Category Archives: Stem Cell Medicine

The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy – JD Supra

Stem cell therapy, also known as regenerative medicine, has been around for decades, but in recent years, the use of and interest in stem cell therapy has increased exponentially. The dramatic utilization of stem cell therapy, and the increasing government spend related to these novel techniques, have now caught the eye of federal regulators and prosecutors. In this client alert, we profile some brief context of stem cell therapy, the governments regulations governing these techniques, and some of the best practices for those interested in this emerging space.

Stem cells are cells from which all other cells with specialized functions are generated (i.e., the bodys raw materials). Stem cells may duplicate themselves to create more stem cells or they may generate cells with a specific function like blood or brain cells.

Stem cell therapy is used to repair or replace damaged tissue or cells within the body. Many in the medical community are hopeful that stem cell therapy can be used to treat a wide array of conditions and diseases from multiple sclerosis to vision loss to traumatic spinal cord injuries to Lou Gehrigs disease just to name a few.

The Food and Drug Administration (FDA) oversees and regulates stem cell therapy treatments. While the FDA has acknowledged that stem cell therapy has the potential to treat diseases or conditions for which few treatments exist, there are still only a few treatments that have actually been approved by the FDA. Many treatments are still only in early investigatory stages.

The FDA has recognized the massive potential that stem cell therapy has in allowing patients treatments for various conditions. Consequently, in 2017, the FDA issued guidance indicating its intent to exercise enforcement discretion as a means to support and expedite the development of regenerative medicine products. This enforcement discretion period was to allow innovators time to determine whether to submit an Investigational New Drug (IND) or marketing application and, if such an application is needed, to prepare and submit the application as appropriate. The FDA, however, has made clear its enforcement discretion policy only applies to products that do not raise potential significant safety concerns. What the FDA considers significant is debatable, creating uncertainty and ambiguity for those who might be relying on the FDAs enforcement discretion period.

Initially, the FDA stated that its enforcement discretion period would last through November 2020. But in July 2020, the FDA extended its enforcement discretion period through May 2021 a fast-arriving date. It remains unclear whether the FDA intends to extend the time period of its enforcement discretion any further, but either way, stem cell therapy providers would be well-served by planning for and expecting enforcement efforts to ramp up in the near future.

In 2019, the FDA went to great lengths to warn consumers of the potential fraud that may arise from what it called stem cell therapy hype, and encouraged consumers to make sure any stem cell therapy treatments were either approved or being studied as an IND. The FDAs concerns have led to multiple enforcement actions, including one just last month. On February 1, 2021, for example, the government announced the indictment of Ashton Derges, a healthcare provider in Missouri, who marketed stem cell shots as a successful treatment for various conditions, including COVID-19. According to the indictment, Derges was paid nearly $200,000 by patients for the stem cell shots, none of which actually contained stem cells at all. While this alleged fraud was not particularly sophisticated, it nonetheless marked a significant development: the governments first criminal prosecution of those touting stem cell therapies.

But blatant fraud is not the only type of stem cell therapy case the government has expressed interest in investigating. A primary concern of the government is the marketing and use of unproven stem cell treatments as miracle cures. A good case study of the risks associated with aggressive marketing of stem cell therapy is a case out of Florida involving US Stem Cell Clinic Inc. The clinic was marketing stem cell therapy to treat conditions and diseases such as Parkinsons disease, stroke, and brain injuries none of which were approved by the FDA. And, much of the marketing that US Stem Cell Clinic used promised almost miraculous results. As a result, last year, the FDA successfully permanently enjoined the US Stem Cell Clinic from selling or providing those stem cell therapy treatments. Notably, this case was pursued by the FDA despite the FDA explicitly stating its intent to be lenient with emerging stem cell therapy treatments.

Stem cell therapy is a groundbreaking medical tool with great possibilities to treat a plethora of diseases and conditions. As the industry continues to expand, so will the governments interest. Our firm continues to see an uptick in cases involving stem cell therapy treatments. And we have successfully assisted clients in avoiding unnecessary scrutiny by the FDA and other government regulators.

If you are in the stem cell therapy industry or are considering offering stem cell therapy treatments, we recommend that you:

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The Governments Watchful Eye on Fraud Stemming from Stem Cell Therapy - JD Supra

Uprooting Cancer: Innovative Hydrogel Rapidly Reverts Cancer Cells Back to Cancer Stem Cells – SciTechDaily

The cancer stem cells cultured on the DN gel formed a tumor when injected into mice brain. Credit: Jun Suzuka et al., Nature Biomedical Engineering, March 29, 2021

A hydrogel, a type of soft matter, developed at Hokkaido University successfully reverted cancer cells back to cancer stem cells within 24 hours, in six different human cancer types. This could lead to the development of anti-cancer stem cell drugs and personalized medicines.

An innovative hydrogel called a double network (DN) gel can rapidly reprogram differentiated cancer cells into cancer stem cells, researchers at Hokkaido University and the National Cancer Center Research Institute have reported in the journal Nature Biomedical Engineering. The hydrogel can be used to help develop new cancer therapies and personalized medicines targeting cancer stem cells.

Cancer is the leading cause of death in developed countries, and more than 8.6 million people die from cancer annually worldwide. Despite the advancement of treatments, the 5-year survival rate of patients with advanced-stage cancer remains low. One reason is that cancer tissues contain cancer stem cells, which are resistant to chemotherapies and radiotherapies. These cells can hide as roots or circulate in the body, causing cancer recurrence.

Cancer stem cells are a major target for anti-cancer drugs, but they are difficult to identify because they are present in very small numbers in cancer tissues, explained Professor Shinya Tanaka of Hokkaido Universitys Faculty of Medicine. Understanding the molecular mechanisms of cancer stem cells is crucial for developing better cancer treatments.

Cancer stem cells require a very specific microenvironment. In this study, the research team investigated whether their DN gel could recreate the right conditions to induce cancer stem cells. The DN gel consists of a network of two chemicals and incorporates a high volume of water, giving it soft and wet characteristics resembling biological tissues.

In the study, the DN gel rapidly reprogrammed differentiated cancer cells into cancer stem cells in just 24 hours in six different human cancer cell lines brain cancer, uterine cancer, lung cancer, colon cancer, bladder cancer, and sarcoma. After cancer cells were placed on the DN gel, they started to form spherical structures and produce specific molecules known to be markers of cancer stem cells such as SOX2 and Oct3/4, aka Yamanaka factors, named after the Nobel Prize laureate, suggesting they had been reprogrammed.

Human brain cancer cells cultured on the DN gel expressed a stem cell marker protein SOX 2 (green). Credit: Jun Suzuka et al., Nature Biomedical Engineering, March 29, 2021

The researchers also uncovered some of the molecular mechanisms involved in cancer cell reprogramming. They found that calcium channel receptors and the protein osteopontin were essential for the induction of cancer stem cells. They also found that brain cancer cells from a patient that had been cultured on the DN gel produced receptors called platelet-derived growth factor receptors. By adding a molecular inhibitor of these receptors, they were able to target and eradicate the cancer stem cells, suggesting that the DN gel could be used to select therapeutic drugs. In addition, they showed that the brain cancer cells that had been cultured on DN gel formed tumors efficiently when transplanted into mice brain, suggesting the stemness of the cancer cells.

This study paves the way for research into drugs that can target cancer stem cells. In the future, the DN gel could be used to enhance cancer cell type diagnosis and to produce personalized medicines, which could improve the prognosis of cancer patients, said Shinya Tanaka.

Reference: Rapid reprogramming of tumour cells into cancer stem cells on double-network hydrogels by Jun Suzuka, Masumi Tsuda, Lei Wang, Shinji Kohsaka, Karin Kishida, Shingo Semba, Hirokazu Sugino, Sachiyo Aburatani, Martin Frauenlob, Takayuki Kurokawa, Shinya Kojima, Toshihide Ueno, Yoshihiro Ohmiya, Hiroyuki Mano, Kazunori Yasuda, Jian Ping Gong and Shinya Tanaka, 29 March 2021, Nature Biomedical Engineering. DOI: 10.1038/s41551-021-00692-2

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Uprooting Cancer: Innovative Hydrogel Rapidly Reverts Cancer Cells Back to Cancer Stem Cells - SciTechDaily

Multiple sclerosis: Recent research on causes and treatments – Medical News Today

Multiple sclerosis (MS) causes a wide range of symptoms involving the brain, optic nerves, and spinal cord. Research is only just beginning to reveal who is at risk and what causes the condition.

MS is a chronic condition affecting 2.8 million people worldwide. While treatment options are currently limited, trials of several new approaches are underway.

Researchers believe that MS is an autoimmune disorder. This type of illness involves the immune system attacking healthy cells, much as it would attack viruses or bacteria.

In the case of MS, the immune system attacks the myelin sheath that surrounds nerve cells. The attack causes lesions to form, and over time, these cause scarring, which leads to nerve damage and reduced function.

As a result of this damage, a person with MS may experience numbness and tingling sensations, fatigue, muscle weakness, dizziness and vertigo, memory issues, and vision problems, among other symptoms.

There are four types of MS: clinically isolated syndrome (CIS), relapsing-remitting MS, primary progressive MS, and secondary progressive MS.

CIS is a single episode of MS-like symptoms that lasts for at least 24 hours. People with CIS do not necessarily have MS, but experiencing an episode can be the first sign of the condition.

Treating MS involves interdisciplinary care, including rehabilitation, disease-modifying drugs (DMARDs), and complementary and alternative therapies.

Scientists do not fully understand the risk factors for MS and the mechanisms of the condition. However, they are making new headway in the search for answers and improvements in treatment.

What does the latest research show about the risk factors, mechanisms, and treatments of MS? In this Special Feature, Medical News Today takes a closer look.

French neurologist Jean-Martin Charcot first described the features of MS in 1868. He noted the differences between this condition and the tremor of paralysis agitans, a symptom of the neurological condition later named Parkinsons disease.

The three symptoms associated with MS at the time were called Charcots triad. They included a characteristic tremor, involuntary eye movements, also known as nystagmus, and scanning speech, which some call staccato or explosive speech.

Decades later, the invention of MRI scans helped doctors diagnose MS. Treatment with steroids became commonplace, and doctors then began to use medications in a class of drugs called interferons. The Food and Drug Administration (FDA) first approved interferons for use in people with MS in 1993.

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Although scientists and healthcare professionals understand the defining features of MS, several aspects of the condition remain a mystery.

While researchers recognize that MS is an autoimmune condition, they do not understand why immune cells attack myelin.

Also, diagnosing MS is still an ambiguous process because its symptoms are similar to those of many other health conditions.

In addition, experts do not know why women are 23 times more likely to be diagnosed with MS than men.

Research suggests that risk factors of MS include a lack of vitamin D or sunlight, smoking, obesity, a history of infection with the Epstein-Barr virus, being female, and possibly having inherited specific genes, as well as environmental factors.

More recently, the gut microbiota has emerged as a possible risk modulator.

A recent overview of clinical research found that people with MS had larger populations of Pedobacteria, Flavobacterium, Pseudomonas, Mycoplana, Acinetobacter, Eggerthella, Dorea, Blautia, Streptococcus, and Akkermansia bacteria in their intestines than people without MS.

People with MS also had reduced populations of Prevotella, Bacteroides, Parabacteroides, Haemophilus, Sutterella, Adlercreutzia, Coprobacillus, Lactobacillus, Clostridium, Anaerostipes, and Faecalibacterium bacteria.

Researchers speculate that balancing out the populations of gut bacteria in people with MS may reduce inflammation and the overactivation of the immune system.

Research from the MS Society Edinburgh Centre for MS Research found that people with MS had reduced numbers of inhibitory neurons, compared with people who did not have the condition.

However, people with MS had as many stimulating neurons as those without the condition. This was true even for people who had received their MS diagnoses many years earlier.

These findings help reveal the types of neurons affected by MS, shedding more light on how the condition evolves within the body. The research may also offer insight into treatments that could protect the targeted neurons.

DMARDs that health authorities have recently approved as MS treatments include cladribine (Mavenclad) and siponimod (Mayzent) for relapsing-remitting and active secondary progressive forms of the condition.

Cladribine targets lymphocytes, white blood cells responsible for attacks on myelin. Siponimod harnesses specific white blood cells that attack myelin and prevents them from circulating in the body.

However, due to their interactions with the immune system, these drugs may lead to a reduction in lymphocytes, making a person vulnerable to infections.

The medicines actions may also contribute to reduced responses to vaccines in people who receive routine vaccinations. With the introduction of COVID-19 vaccines, scientists have investigated whether people with MS who take medications such as cladribine can have adequate responses to vaccines.

The latest research indicates that people taking cladribine do produce protective antibodies to other common vaccines, despite having decreased lymphocyte levels induced by the medication.

This result gives scientists and others in the medical community hope that people who take these drugs for MS will have similarly adequate responses to COVID-19 vaccines.

Some scientists are currently investigating the potential for stem cell therapy for MS. In a phase 1 study conducted at the Karolinska Institute, in Stockholm, Sweden, seven people with progressive MS received infusions of stem cells derived from each participants own bone marrow.

As early as 7 days after administration of the stem cell therapy, researchers found evidence of positive changes in the participants immune systems. At 12 weeks, five out of six participants had no new characteristic lesions on follow-up MRI brain scans.

As their understanding of the condition evolves, many scientists are investigating the root cause of MS.

An analysis of the current data has revealed a possible connection between gut health and the condition. Data revealing relationships between the gut microbiota and the brain continually emerge, and scientists are hopeful that diet modifications, probiotics, and certain drugs that balance the gut microbiome will play a role in MS treatment.

Also in development are remyelination and neuroprotection therapies. The latter aim to protect the axons and myelin from further damage, while the former could restore lost function for people with MS.

Meanwhile, immunotherapy drugs would protect the nerves from destruction and rebuild neurons that have already sustained damage.

Another potential treatment in phase 1 trials is a tumor necrosis factor-alpha (TNF-alpha) inhibitor called MYMD-1. TNF-alpha is a type of cytokine produced by white blood cells that regulates some aspects of the immune system.

Overproduction of this cytokine is associated with several autoimmune conditions, including MS. MYMD-1 is a new type of TNF-alpha blocker that shows promise as a treatment for MS and other conditions.

Trials for therapies involving the gut microbiome, stem cells, neuroprotective treatments, remyelination, and MYMD-1 are still in the earliest stages. However, the possibilities provide hope that ongoing research will lead to effective ways to prevent MS and better methods of treatment.

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Multiple sclerosis: Recent research on causes and treatments - Medical News Today

First CAR T-Cell Therapy for Multiple Myeloma: Abecma – Medscape

Chimeric antigen receptor (CAR) T-cell therapy, described as a "living drug," is now available for patients with relapsed/refractory multiple myeloma who have been treated with four or more prior lines of therapy.

The US Food and Drug Administration (FDA) said these patients represent an "unmet medical need" when it granted approval for the new product idecabtagene vicleucel (ide-cel; Abecma), developed by bluebird bio and Bristol-Myers Squibb.

Ide-cel is the first CART-cell therapy to gain approval for use in multiple myeloma. It is also the first CAR T-cell therapy to target B-cell maturation antigen.

Previously approved CAR T-cell products target CD19 and have been approved for use in certain types of leukemia and lymphoma.

All the CAR T-cell therapies are customized treatments that are created specifically for each individual patient from their own blood. The patient's own T cells are removed from the blood, are genetically modified and expanded, and are then infused back into the patient. These modified T cells then seek out and destroy blood cancer cells, and they continue to do so long term.

In some patients, this has led to eradication of disease that had previously progressed with every other treatment that had been tried results that have been described as "absolutely remarkable" and "one-shot therapy that looks to be curative."

However, this cell therapy comes with serious adverse effects, including neurologic toxicity and cytokine release syndrome (CRS), which can be life threatening. For this reason, all these products have a risk evaluation and mitigation strategy, and the use of CAR T-cell therapies is limited to designated centers.

In addition, these CAR T-cells products are phenomenally expensive; hospitals have reported heavy financial losses with their use, and patients have turned to crowdfunding to pay for these therapies.

The FDA noted that approval of ide-cel for multiple myeloma is based on data from a multicenter study that involved 127 patients with relapsed/refractory disease who had received at least three prior lines of treatment.

The results from this trial were published in February 2021 in the New England Journal of Medicine (NEJM).

An expert not involved in the trial described the results as "phenomenal."

Krina Patel, MD, an associate professor in the Department of Lymphoma/Myeloma at the University of Texas MD Anderson Cancer Center, Houston, Texas, said that "the response rate of 73% in a patient population with a median of sixlines of therapy, and with one-third of those patients achieving a deep response of complete response or better, is phenomenal.

"We are very excited as a myeloma community for this study of idecabtagene vicleucel for relapsed/refractory patients," Patel told Medscape Medical News at the time.

The lead investigator of the study, Nikhil Munshi, MD, of Dana-Farber Cancer Institute, Boston, Massachusetts, commented: "The results of this trial represent a true turning point in the treatment of this disease. In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients."

In my 30 years of treating myeloma, I have not seen any other therapy as effective in this group of patients. Dr Nikhil Munshi

Both experts highlighted the poor prognosis for patients with relapsed/refractory disease. Recent decades have seen a flurry of new agents for myeloma, and there are now three main classes of agents: immunomodulatory agents, proteasome inhibitors, and anti-CD38 antibodies.

Nevertheless, in some patients, the disease continues to progress. For patients for whom treatments with all three classes of drugs have failed, the median progression-free survival is 3 to 4 months, and the median overall survival is 9 months.

In contrast, the results reported in the NEJM article showed that overall median progression-free survival was 8.8 months, but it was more than double that (20.2 months) for patients who achieved a complete or stringent complete response.

Estimated median overall survival was 19.4 months, and the overall survival was 78% at 12 months. The authors notethat overall survival data are not yet mature.

The patients who were enrolled in the CAR T-cell trial had undergone many previous treatments. They had undergone a median for six prior drug therapies (range, three to 16), and most of the patients (120, 94%) had also undergone autologous hematopoietic stem cell transplant.

In addition, the majority of patients (84%) had disease that was triple refractory (to an immunomodulatory agent, a proteasome inhibitor, and an anti-CD38 antibody), 60% had disease that was penta-exposed (to bortezomib, carfilzomib, lenalidomide, pomalidomide, and daratumumab), and 26% had disease that was penta-refractory.

In the NEJM article, the authors report that about a third of patients had a complete response to CAR T-cell therapy.

At a median follow-up of 13.3 months, 94 of 128 patients (73%) showed a response to therapy (P < .001); 42 (33%) showed a complete or stringent complete response;and 67 patients (52%) showed a "very good partial response or better," they write.

In the FDA announcement of the product approval, the figures for complete response was slightly lower. "Of those studied, 28% of patients showed complete response or disappearance of all signs of multiple myeloma to Abecma, and 65% of this group remained in complete response to the treatment for at least 12 months," the agency noted.

The FDA also noted that treatment with Abecma can cause severe side effects. The label carries a boxed warning regarding CRS, hemophagocytic lymphohistiocytosis/macrophage activation syndrome, neurologic toxicity, and prolonged cytopenia, all of which can be fatal or life threatening.

The most common side effects of Abecma are CRS, infections, fatigue, musculoskeletal pain, and a weakened immune system. Side effects from treatment usually appear within the first 1 to 2 weeks after treatment, but some side effects may occur later.

The agency also noted that, to further evaluate the long-term safety of the drug, it is requiring the manufacturer to conduct a postmarketing observational study.

"The FDA remains committed to advancing novel treatment options for areas of unmet patient need," said Peter Marks, MD, PhD, director of the FDA's Center for Biologics Evaluation and Research.

"While there is no cure for multiple myeloma, the long-term outlook can vary based on the individual's age and the stage of the condition at the time of diagnosis. Today's approval provides a new treatment option for patients who have this uncommon type of cancer."

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First CAR T-Cell Therapy for Multiple Myeloma: Abecma - Medscape

Allogeneic hematopoietic stem cell transplantation for therapy-related myeloid neoplasms following treatment of a lymphoid malignancy – DocWire News

This article was originally published here

Leuk Lymphoma. 2021 Mar 29:1-10. doi: 10.1080/10428194.2021.1894645. Online ahead of print.

ABSTRACT

Advances in lymphoma treatment lead to increasing numbers of long-term survivors. Thus, secondary therapy-related myeloid neoplasms (t-MN) gain clinical relevance. We analyzed 38 t-MN patients receiving an allogeneic stem cell transplantation (SCT) after successful cytotoxic treatment of Hodgkin lymphoma (n = 9), non-Hodgkin lymphoma (n = 24), and multiple myeloma (n = 5), who had developed t-AML (n = 20) or t-MDS (n = 18). Overall survival (OS) and relapse-free survival at 3 years after allogeneic SCT were 43% and 39%. The cumulative incidences of relapse and non-relapse mortality (NRM) at 3 years were 19% and 42%. More than one therapy line for the lymphoid malignancy resulted in a significantly higher NRM rate and inferior 3-year-OS. Our data indicate that allogeneic SCT for patients with t-MN after treatment of a lymphoid malignancy leads to OS rates comparable to patients transplanted for de novo MN. Multiple lines of lymphoma therapy increase NRM and lead to inferior survival after allogeneic SCT.

PMID:33779471 | DOI:10.1080/10428194.2021.1894645

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Allogeneic hematopoietic stem cell transplantation for therapy-related myeloid neoplasms following treatment of a lymphoid malignancy - DocWire News

Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director – Benzinga

GOLDEN, CO / ACCESSWIRE / April 3, 2021 / Vitro Biopharma, Inc. (formerly Vitro Diagnostics, Inc.) announced the appointment of Dr. Caroline Mosessian, PhD, DRSc, FACMPE, ACHE as its acting Director of Regulatory Affairs. Dr. Mosessian has an extensive background in regulatory science including a PhD, MS and Masters in Healthcare Administration degrees from USC in LA. In 2016 she was honored with the prestigious Top Ranked US Executive Award awarded to the top 1% of the millions of active executives in the United States. She is a trusted advisor for strategic development and operations to a variety of technology firms promoting innovation excellence to enhance quality of life for patients, caregivers and providers while optimizing outcomes and overall corporate success. In addition to regulatory expertise, she has extensive experience in the development, management and licensing of intellectual property, government and private fund raising, strategic planning and clinical research operations. She is fluent in several languages that support her international business development skills. She is also actively involved in local, national and international charitable organizations that emphasize humanitarian aid.

She has led numerous clinical studies of medical devices and pharmaceuticals through regulatory agency approval including the FDA and EMA leading to successful development of multi-million dollar clinical programs. She presently assists Vitro Biopharma in the guidance, drafting and submission of its pending IND phase I application to the FDA (Randomized, Double-blinded, placebo-controlled study of the safety and efficacy of therapeutic treatment with AlloRx Stem Cells in adults with COVID-19). As a result, the FDA has authorized several expanded access/compassionate use INDs that employ IV infusion of AlloRx Stem Cells in the treatment of COVID-19 patients.

These results together with several additional clinical studies using MSCs are now providing substantial clinical evidence of safety and efficacy of stem cell therapy for COVID-19. Furthermore, since MSC therapy is independent of the genome of the virus, this MSC therapy is likely to be effective in treatment of COVID-19 patients infected with new variants resulting from viral mutation.

Dr. Jack Zamora, MD and CEO said, "We are elated to add Dr Mosessian to our regulatory team targeting FDA approval of AlloRx Stem Cells. She has been instrumental in establishing a strong working relationship between Vitro Biopharma and the FDA. She will also be a key driver of the execution of our pending Phase I trial and future INDs targeting additional indications of AlloRx Stem Cells."

Dr. Mosessian said, "I am inspired by Vitro Biopharma's mission to deliver innovative solutions and access to regenerative therapies to deliver unmet needs of the vulnerable patients. I feel fortunate to become part of the team thriving to achieve such an ambitious goal."

John Evans C.F.O. and Chairman of the Board said "We are pleased to have Caroline join the Board of Directors of the company, she adds such a wide breadth of experience in the regulatory, clinical and legal areas of board governance.

ABOUT VITRO BIOPHARMA

Out of years of research, we developed our patent-pending and proprietary line of umbilical cord derived stem cells AlloRx Stem Cells now being used in offshore regenerative medicine clinical trials. Our stem cells are used in regenerative medicine clinical trials with our partner in the Cayman Islands http://www.DVCStem.com. We have a recently approved clinical trial using our AlloRx Stem Cells to treat musculoskeletal conditions at The Medical Pavilion of the Bahamas http://www.tmp-bahamas.com in Nassau. Our nutraceutical stem cell activation product, STEMulize complements AlloRx Stem Cells as an adjuvant therapy to optimize therapeutic outcomes.

Vitro Biopharma has a proprietary and scalable manufacturing platform to provide stem cell therapies to critically ill Coronavirus patients and other conditions including multiple sclerosis, OA, Crohn's disease, and numerous medical conditions that are under-treated by the current standard of care. Our cGMP manufacturing is CLIA, ISO9001, ISO13485 certified and we are FDA registered. Our stem cells have been shown to be safe and effective in Phase I clinical trials.

Forward-Looking Statements

Statements herein regarding financial performance have not yet been reported to the SEC nor reviewed by the Company's auditors. Certain statements contained herein and subsequent statements made by and on behalf of the Company, whether oral or written may contain "forward-looking statements". Such forward-looking statements are identified by words such as "intends," "anticipates," "believes," "expects" and "hopes" and include, without limitation, statements regarding the Company's plan of business operations, product research and development activities, potential contractual arrangements, receipt of working capital, anticipated revenues, and related expenditures. Factors that could cause actual results to differ materially include, among others, acceptability of the Company's products in the market place, general economic conditions, receipt of additional working capital, the overall state of the biotechnology industry and other factors set forth in the Company's filings with the Securities and Exchange Commission. Most of these factors are outside the control of the Company. Investors are cautioned not to put undue reliance on forward-looking statements. Except as otherwise required by applicable securities statutes or regulations, the Company disclaims any intent or obligation to update publicly these forward-looking statements, whether as a result of new information, future events or otherwise.

CONTACT: Dr. Jack Zamora, MD Chief Executive Officer Vitro Biopharma, Inc. (303) 999-2130 x 1 http://www.vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.

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Vitro Biopharma Retains Leading Health Care Executive as Acting Director of Regulatory Affairs & Director - Benzinga

Orca-T Offers an Alternative to HSCT With Improved Patient Experience – OncLive

Advances in the treatment of patients with leukemias and lymphomas have led to a significant improvement in survival, which has increased the need for bone marrow transplant as a later-line therapy, said Mehrdad Abedi, MD, who added that Orca-T, a high precision cell therapy, confers significant antitumor activity, minimizes the incidence of acute and chronic graft-vs-host disease (GVHD), and causes less adverse effects (AEs) compared with standard bone marrow transplant among these patients.

There is a lot of research [ongoing]; the holy grail of research is trying to figure out whether we can separate the graft-vs-leukemia or graft-vs-lymphoma effect from GVHD, said Abedi. [The Orca-T trial] is basically looking at the past 10 years of research in this area to try to identify the cells that are good from those that are bad.

During the 2021 Transplantation and Cellular Therapy (TCT) Meetings, findings from an analysis of 2 studies demonstrated a significant reduction in cases of GVHD, a higher GVHD relapse-free survival rate, and a lack of treatment-related mortalities with Orca-T when historically compared with hematopoietic stem cell transplant (HSCT).

Additionally, the median time to neutrophil engraftment, median time to platelet engraftment, and median time from day 0 to hospital discharge was shortened with Orca-T compared with HSCT.

In an interview with OncLive during the 2021 TCT Meetings, Abedi, a professor of cancer, hematology/oncology, and internal medicine in the Department of Internal Medicine, Division of Hematology and Oncology at the UC Davis Comprehensive Cancer Center, discussed the challenges of standard transplant, how Orca-T could overcome some of those limitations, and the potential future of transplant in hematologic malignancies.

Abedi: HSCT has been around for more than 50 years in one form or another. It has been used mostly for patients with blood cancers, [such as] leukemia and lymphoma. Allogeneic bone marrow transplants, where we use cells from a donor, are very effective. [They are associated with] a very high response rate for patients who have no other options and whose disease is going to [recur] without transplant.

The problem [with allogeneic bone marrow transplant] is that it [is associated with] AEs. When we give donor cells to patients after high-dose chemotherapy, [which is given] so that the patients body doesnt reject [the cells], even though the cells are a match for the patient, they can still [develop] severe GVHD.

The acute form of GVHD can be life threatening, whereas the chronic form can become a nuisance for the rest of a patients life. A lot of patients suffer [from GVHD] to the point where they regret going through transplant. Fortunately, that is not everybody, but it is still a problem that needs to be solved and an unmet need for the field.

This research has been focused on [the question of]: Are there specific cells in the graft we give to the patients immune cells that can cause GVHD? Can we separate those cells from those that are responsible for causing graft-vs-leukemia effects?

Basically, Orca Bio approached UC Davis a few years ago to [start] collaborative research with our Good Manufacturing Practice [GMP] facility and to produce these products.

Each graft of [the Orca-T] product has stem cells and immune cells in it. The stem cells are what we need to maintain the graft and [allow the product to] stay in the patient for a long time. The immune cells are the ones that can cause graft-vs-leukemia [effects], which is what we want.

From the work that Robert Negrin, [MD] at Stanford University and many other investigators [did], it is very clear that there is a population of T cells called T-regulatory cells that can prevent GVHD. There are other populations, such as the nave T cells or conventional T cells that can cause GVHD. It looks like a smaller number of [those cells] may actually be helpful; they can cause graft-vs-leukemia, but not GVHD.

The graft is basically designed so that we can give stem cells, but they get rid of a lot of conventional T cells that can cause rapid GVHD. [The graft provides] a small amount of conventional T cells that can cause graft-vs-leukemia effects, as well as the regulatory T cells that can prevent GVHD. UC Davis got involved [with this work] because we have a very robust GMP facility. We helped Orca Bio design these protocols and manufacture the cells. Now, [Orca Bio] has moved on to their own facility. I have been involved [with this research] for the past few years.

[We] havent looked at the QOL data, but there have been several short-term and long-term benefits so far that we have seen.

We give high-dose chemotherapy that can get rid of all [the patients] stem cells and leukemia or lymphoma cells. Then, we give the graft; however, after the graft is given, it takes a couple of weeks usually to engraft [before] new cells [develop]. In between, the patients are sick because of the effects of the chemotherapy; patients also have low blood counts.

[With Orca-T] we have seen that the engrafting [occurs] a little bit earlier. For everyday [sooner] the engraftment [occurs], there is less risk of complication and suffering for the patient. That has been a major difference [with Orca-T].

Also, we have noticed that patients in general are doing better [with Orca-T compared with traditional transplant]. When we give high-dose chemotherapy, it is the same whether the patient is on a clinical trial or not. They may still get sick [with Orca-T] because of the effects of chemotherapy.

However, there is also inflammation [that can occur] as the donor cells are trying to establish themselves in the body because some of them attack the body. That inflammation also adds to the problems with chemotherapy. We havent seen that inflammation [with Orca-T]. We have seen some effects from the chemotherapy, but because we dont have the inflammation, other AEs that we see with the standard of care arent seen with Orca-T.

In general, patients do better [with Orca-T vs standard of care], and that has been a universal experience with all of our patients who have gone through the trial so far.

[Patients] just look and feel better. When they are discharged, they are not as sick compared with patients [receiving] the standard of care.

With the standard of care, after we give the graft, we have to give patients a new medication to prevent GVHD because it is such a lethal problem. If we dont put patients on immunosuppressive medications to prevent GVHD, there is a very high chance that they get and die from GVHD. Those immunosuppressive medications are critical.

The way the Orca-T graft is designed is that we dont need as many of those [immunosuppressive] medications. For example, there is a medication called methotrexate that we give on days 1, 3, 6, and 11 after [standard] transplant. That medication can cause a lot of other AEs, such as mouth sores, delayed engraftment, and kidney [problems], that can make the patient miserable. With Orca-T, we dont have to [give methotrexate], which by itself is a huge improvement.

We do give immunosuppressive medications, such as tacrolimus [Envarsus XR] or sirolimus [Rapamune] to these patients, but we dont give 2 or 3 medications as we usually do with the standard of care. Less immunosuppressive medications mean probably less infection, but more importantly, less AEs. Thats [a factor that has made] a big difference in patient experience.

That is a very loaded question. There are a lot of new drugs coming, some of which are very targeted to treat leukemia or lymphoma. Thus far, we havent seen any curative [benefit] with those drugs, so in most situations, we will still need an allogeneic stem cell transplant for patients.

The exceptions [to that] were rare diseases, such as chronic myeloid leukemia [CML], where [an oral medication was approved] and we dont need to transplant patients. That is an example of a targeted treatment that may exclude [the need to] transplant patients. That would be great because transplant is not a trivial procedure and it has a lot of AEs.

However, [CML] is a very specific disease with 1 gene that causes the disease. In most leukemias and lymphomas, multiple genes are involved, so we dont think single-target treatments will get rid of the disease. We still think that allogeneic transplant will be around for a long time.

In fact, if you look at any center in the country, the volume of transplant has substantially increased over time because patients are living longer. Patients end up being able to go to a transplant vs before when many were dying in the middle of their treatment and not getting to transplant.

That being said, there are 2 directions [we can go in]. One is to try to decrease the AEs associated with transplant. This [Orca-T cell therapy] is very effective [in doing this] by targeting the graft-vs-leukemia effect and preventing GVHD. The second direction is to use these allogeneic cells to specifically target the tumor cells. That is why gene modifications, CAR T-cell therapies, and other approaches are coming. They still use allogeneic cells from a donor, but now they are directing them to specifically go after tumor cells.

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Orca-T Offers an Alternative to HSCT With Improved Patient Experience - OncLive

Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy…

SUZHOU and SHANGHAI, China, March 31, 2021 /PRNewswire/ --Gracell Biotechnologies Inc. (NASDAQ: GRCL) ("Gracell"), a global clinical-stage biopharmaceutical company dedicated to developing highly efficacious and affordable cell therapies for the treatment of cancer, announced that they have enrolled the first patient in their pivotal Phase 1/2 clinical study of GC007g, an allogeneic donor-derived anti-CD19 chimeric antigen receptor (CAR)-T cell therapy for the treatment of B-cell acute lymphoblastic leukemia (B-ALL).

GC007g is an allogeneic HLA (human leukocyte antigen)-matched donor-derived CAR-T therapy. Gracell obtained IND approval for GC007g for the treatment of B-ALL from China's National Medical Products Administration (NMPA) and the approval for the pivotal Phase 1/2 clinical study in December 2020. The open-label, single-arm Phase 1/2 study is evaluating the safety and efficacy of GC007g in r/r B-ALL patients.

"We are thrilled to announce the enrollment of the first patient into our registrational Phase 1/2 trial for the allogeneic donor-derived CD19-targeted CAR-T therapy, GC007g, for the treatment of patients with B-ALL," said Dr. Martina Sersch, M.D., Chief Medical Officer of Gracell. "GC007g is a unique treatment approach for B-ALL patients who relapse after allogeneic stem cell transplantation and are not eligible for standard-of-care. With Gracell's innovative portfolio, we are excited to bring novel CAR-T therapies to more patients with high unmet medical need."

About GC007g

GC007g is a donor-derived CD19-directed allogeneic CAR-T cell therapy that has been studied for the treatment of r/r B-ALL in a completed investigator-initiated Phase 1 trial in China, where CAR-T cells were manufactured using T cells from an HLA-matched healthy donor.

About B-ALL

B-ALL, a major form of acute lymphoblastic leukemia (ALL), is one of the most common forms of cancer in children between the ages of two and five and adults over the age of 50.[1]In 2015, ALL affected around 837,000 people globally and resulted in 110,000 deaths worldwide.[2]It is also the most common cause of cancer and death from cancer among children.

About Gracell

Gracell Biotechnologies Inc. ("Gracell") is a global clinical-stage biopharmaceutical company dedicated to discovering and developing breakthrough cell therapies. Leveraging its pioneering FasTCAR and TruUCAR technology platforms, Gracell is developing a rich clinical-stage pipeline of multiple autologous and allogeneic product candidates with the potential to overcome major industry challenges that persist with conventional CAR-T therapies, including lengthy manufacturing time, suboptimal production quality, high therapy cost and lack of effective CAR-T therapies for solid tumors.

Cautionary Noted Regarding Forward-Looking Statements

Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute "forward-looking statements" within the meaning of The Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to, statements relating to the expected trading commencement and closing date of the offering. The words "anticipate," "believe," "continue," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "target," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and the completion of the public offering on the anticipated terms or at all, and other factors discussed in the "Risk Factors" section of the final prospectus filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Gracell specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise. Readers should not rely upon the information on this page as current or accurate after its publication date.

Media contact Marvin Tang marvin.tang@gracellbio.com +86 21 64031522

Investor contact Gracie Tong gracie.tong@gracellbio.com

[1] https://www.cancer.org/cancer/acute-lymphocytic-leukemia/about/key-statistics.html [2] https://www.ncbi.nlm.nih.gov/pmc/articles/PMC5055577

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Gracell Biotechnologies Announces Enrollment of First Patient in Registrational Phase 1/2 Clinical Study for GC007g, an Allogeneic CAR-T Cell Therapy...

Russell Health Highlighted in the Silicon Review’s ’50 Leading Companies of the Year 2021′ – PRNewswire

WILLOWBROOK, Ill., March 31, 2021 /PRNewswire/ --Based in Willowbrook, Illinois, Russell Health, a national marketer and distributor of specialty medical products and services,was recently announced as one of The Silicon Review's "50 Leading Companies of the Year 2021."The feature strategically places the Russell Health brand alongside other tech innovators in industries including marketing, finance, software, sustainability, leadership and health. Russell Health's Profile features a Q&A with the leading tech publication covering the history of the Russell Health brand, services offered, anticipated trends in Stem Cell Recruitment Therapy, continued product category research, and more. Read the full feature here.

About Russell Health: Russell Health and its partners have distributed regenerative therapy products nationwide and achieved profound clinical outcomes in multiple therapeutic areas including cosmetics, wound care, pain management, podiatry, orthopedic, optometry and gynecology.

With their partners and suppliers, they work to provide innovative life-changing and sustaining products and therapies to patients and healthcare providers around the world.

Stem Cell Recruitment Therapy products take advantage of the body's ability to repair itself. Responsibly sourced acellular tissue allografts are helping people of all ages to recover from injuries and get their life back.

Quote about the current landscape and anticipated trends in Stem Cell Recruitment Therapy:

"We do not distribute 'Stem Cells' or 'Stem Cell Procedures'. All our products are acellular and do not contain live stem cells. By using a combination of growth factors and other endogenously synthesized molecules, Stem Cell Recruitment Therapyproducts help to assist the body with repair, reconstruction and supplementation of the recipient's tissue, as mentioned above. During the pandemic, we have seen a lot of patients and physicians searching for alternative treatments like ours that are safe and effective without posing any additional risks of infection while providing the clinic."(Ryan Salvino, CEO of Russell Health)

Quote about Russell Health's involvement in Stem Cell Recruitment Therapy research:

"We are currently working with some of the top leaders in the regenerative medicine field to continue to grow and provide new innovative products to our customers and their patients. We are always looking for new breakthrough products in the market to stay abreast on the new technologies and innovations in the field. We are consistently documenting patient results to provide clinicians with testimonialson how effective the Stem Cell Recruitment Therapy products are and how they are positively affecting patients' lives." (Jonathan Benstent, Vice President of Russell Health)

Visit Russell Health online to learn more about Stem Cell Recruitment Therapy. For media inquiries or to contact the Russell Health team directly, please visit http://www.russellhealth.comor email [emailprotected].

Contact: Veronica Bennett Phone: 844-249-6200 Email: [emailprotected] Mailing Address: 621 Plainfield Rd., Willowbrook, IL 60527 Online: http://www.russellhealth.com Social Media: http://www.linkedin.com/company/russell-health/

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Russell Health Highlighted in the Silicon Review's '50 Leading Companies of the Year 2021' - PRNewswire

LGL Leukemia: Overview, Symptoms, and Treatment – Healthline

Large granular lymphocytic (LGL) leukemia is a kind of cancer that affects blood cells. The disease is rare: Only about 1,000 people per year are diagnosed with it. It affects men and women in roughly equal numbers, and most of those diagnosed are over 60 years old.

Heres what we know about this form of leukemia.

Your blood is made up of four different parts:

Some of your white blood cells are larger than the rest. These cells contain tiny granules that can be seen under a microscope.

In people with LGL leukemia, these large, granular white blood cells copy themselves until there are too many. The fact that the white blood cells (also called lymphocytes) replicate themselves is what makes this disorder a type of cancer.

Your blood contains two different types of lymphocytes: T-cells (T-LGL) and B-cells, which are also known as natural killer cells (NK-LGL). B-cells fight off invading bacteria and viruses. T-cells attack other cells in your body that have become harmful, like cancer cells.

When your T-cells are copying themselves too much, you have T-LGL leukemia. If your natural killer cells are replicating too much, you have NK-LGL leukemia.

Most cases of LGL leukemia are chronic and slow-growing, whether theyre NK-LGL or T-LGL. Only around 10 percent of all LGL cases are aggressive, fast-growing cells.

Researchers dont yet know what causes LGL leukemia. The disorder is associated with a genetic change or mutation, usually to the STAT3 and STAT5b genes.

Between 10 and 40 percent of people with LGL leukemia also have a history of autoimmune disorders. The immune disorder most often associated with LGL leukemia is rheumatoid arthritis (RA).

About 20 percent of those with LGL leukemia also have RA. So far, researchers have been unable to determine which disorder began first.

Most people who are diagnosed with LGL leukemia will experience some of these symptoms:

A healthcare professional may look for other symptoms, too, including:

You should contact your doctor and seek treatment if youre having recurring infections, especially if you have a fever that doesnt go away or you have other infection symptoms, such as swelling or sores, that arent getting better.

To find out if you have LGL leukemia, a healthcare professional will analyze a sample of your blood. Your doctor may also take a sample of your bone marrow, often from your hip area, to look for abnormal cells.

To determine which type of LGL leukemia you have, your doctor could use a laser technology called flow cytometry to identify whether T-cells or NK-cells are replicating too much.

Most cases of LGL leukemia are slow growing. Doctors sometimes take a wait-and-watch approach to treatment.

You may not start treatment until tests or symptoms show that the condition has reached a certain level.

If tests show that your neutrophil levels have dropped too much, your doctor may start treatment at that time. Around 45 percent of people with this condition needed immediate treatment.

When treatment for LGL leukemia begins, it may or may not follow the same intensive course as other cancer treatments.

Most people will eventually need some combination of chemotherapy and immune-suppressing drug therapy. Your medications could include:

In some cases, treatment for LGL leukemia involves a bone marrow or stem cell transplant. Its also possible that your treatment could include removing your spleen, an organ in your abdomen that filters your blood and helps maintain your immune system.

Two to three times a year, you may need to visit a healthcare professional to have bloodwork done to monitor your health and the activity of your white blood cells.

While theres no cure for LGL leukemia, most cases progress very slowly, unlike other forms of leukemia. One study that followed 1,150 people with the disease found that they lived an average of 9 years after their diagnosis.

The more aggressive form of LGL leukemia doesnt respond well to treatment. Life expectancy is likely much shorter for those with this very rare subtype of LGL leukemia.

LGL leukemia is a rare type of cancer where large white blood cells copy themselves too much, making your body prone to frequent infections.

Most cases of LGL leukemia are slow-growing, so treatment might not be necessary at first.

Eventually, people with this condition might need a combination of chemotherapy and immunosuppressing medications to slow the growth of cancer cells. Theres no cure yet for LGL leukemia.

A small percentage of cases are a faster-growing type of leukemia that doesnt respond well to treatments. Life expectancy for this subtype is shorter than the slow-growing type.

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LGL Leukemia: Overview, Symptoms, and Treatment - Healthline