Yearly Archives: 2020


Stem Cell Clinic > 2020

Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update – GlobeNewswire

By Stem Cell Treatment

- Compelling data in synovial sarcoma in the Phase 1 trial, and continued momentum in the Phase 2 SPEARHEAD-1 trial with goal to launch ADPA2M4 for sarcoma in 2022 -

- Encouraging demonstration of the potential of SPEAR T-cell platform in four new solid tumor indications -

- Co-development and co-commercialization agreement with Astellas to develop stem-cell derived off-the-shelf CAR-T and TCR T-cell therapies -

PHILADELPHIA and OXFORDSHIRE, United Kingdom, Feb. 27, 2020 (GLOBE NEWSWIRE) -- Adaptimmune Therapeutics plc(Nasdaq:ADAP), a leader in cell therapy to treat cancer, today reported financial results for the fourth quarter and year endedDecember 31, 2019, and provided a business update.

The last 12 months have been transformative. We reported responses in five different solid tumors, confirming that our SPEAR T-cell platform can treat a wide range of cancers. We also validated the potential of our allogeneic platform by demonstrating that we can generate functional T-cells from stem cells, and by signing our first major strategic deal in five years with Astellas, said Adrian Rawcliffe, Adaptimmunes Chief Executive Officer. With our passionate and skilled teams, and our world class capabilities, we are developing our cell therapy pipeline for a range of tumor indications, aiming to launch our first product in 2022 for people with sarcoma.

Responses in five solid tumor indications demonstrate SPEAR T-cell potential to treat cancerBased on compelling response data in synovial sarcoma from the Phase 1 trial announced in May of last year, and updated at ESMO and CTOS, the Phase 2 SPEARHEAD-1 trial was initiated with ADP-A2M4 in synovial sarcoma and myxoid/ round cell liposarcoma (MRCLS). The product was granted Orphan Drug Designation, for the treatment of soft tissue sarcomas, and Regenerative Medicine Advanced Therapy designation, for synovial sarcoma, by the US FDA. The Company aims to launch ADPA2M4 for sarcoma in 2022.

In January of this year, partial responses in liver, melanoma, gastro-esophageal junction, and head and neck cancers were reported. These early data in multiple indications demonstrate the potential of Adaptimmunes SPEAR T-cell platform across multiple targets and a range of solid tumors. Further updated data will be presented at upcoming medical / scientific meetings.

Partnerships to develop next-generation and off-the-shelf cell therapiesIn January of this year, a co-development and co-commercialization agreement with Astellas, through its wholly owned subsidiary Universal Cells, Inc., was announced for stem-cell derived allogeneic CAR-T and TCR T-cell therapies. The Company has received an upfront payment of $50 million under the agreement and is entitled to receive research funding of up to $7.5 million per year.

This agreement covers the co-development and co-commercialization of up to three T-cell therapies and leverages Astellas Universal Donor Cell Platform and Adaptimmunes stem-cell derived allogeneic T-cell platform. This new collaboration may encompass both CAR-T and TCR T-cell approaches, including Adaptimmunes novel HLA-independent TCR (HiT) platform.

In 2019, Adaptimmune announced agreements with Alpine Immune Sciences and Noile-Immune to develop further next-generation products.

Leadership, manufacturing and financial updates strengthen fully integrated cell therapy company positionAdrian Rawcliffe assumed the role of Chief Executive Officer effective September 1, 2019 and John Lunger became Chief Patient Supply Officer effective August 1, 2019. In January 2020, a series of changes to the R&D leadership were announced, including the appointment of Elliot Norry as Chief Medical Officer. These leadership changes strengthen the scientific and clinical organization from early to late stage and accelerate the application of translational science learnings to therapeutic candidates and trials, as Adaptimmune becomes a late-stage cell therapy company aiming to launch a commercial product in 2022.

Adaptimmunes in-house cell manufacturing facility located at the Navy Yard in Philadelphia, PA, is achieving a 25-day processing time for production of SPEAR T-cells. 95% of patient batches manufactured in 2019 met manufacturing criteria set for those batches. The Navy Yard facility was approved as a manufacturing source for a number of the Companys clinical trials in Europe. The Company also produced its first GMP batch of lentiviral vector using an in-house, proprietary suspension process at its dedicated manufacturing space within the Cell and Gene Therapy Catapult Manufacturing Centre at Stevenage, UK.

Finally, on January 24, 2020, the Company closed an underwritten public offering of 21,000,000 American Depository Shares (ADSs) which, together with the full exercise by the underwriters on February 7, 2020 of their option to purchase an additional 3,150,000 ADSs, generated net proceeds of approximately$89.8 million. Following the agreement with Astellas and the public offering of ADSs described above, the Company is funded into 2H 2021.

Planned 2020 milestonesFirst Half of 2020

Second Half of 2020

Financial Results for the fourth quarter and year ended December 31, 2019

Financial GuidanceThe Company believes that its existing cash and cash equivalents and marketable securities, Total Liquidity, together with the net proceeds received from the underwritten public offering in January 2020, the additional net proceeds generated from the exercise in full of the underwriters option in February 2020 and the upfront payment received under its agreement with Astellas in January 2020, will fund the Companys current operating plan into the second half of 2021.

Conference Call InformationThe Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, February 27, 2020. The live webcast of the conference call will be available via the events page of Adaptimmunes corporate website at http://www.adaptimmune.com. An archive will be available after the call at the same address. To participate in the live conference call, if preferred, please dial (833) 652-5917 (U.S. or Canada) or +1 (430) 775-1624 (International). After placing the call, please ask to be joined into the Adaptimmune conference call and provide the confirmation code (6083408).

About AdaptimmuneAdaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Companys unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T-cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors.

Forward-Looking StatementsThis release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the SEC on November 6, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Total Liquidity (a non-GAAP financial measure)Total Liquidity is the total of cash and cash equivalents and marketable securities. Each of these components appears in the Companys Consolidated Balance Sheet. The U.S. GAAP financial measure most directly comparable to Total Liquidity is cash and cash equivalents as reported in the Companys Consolidated Financial Statements, which reconciles to Total Liquidity as follows (unaudited):

The Company believes that the presentation of Total Liquidity provides useful information to investors because management reviews Total Liquidity as part of its management of overall liquidity, financial flexibility, capital structure and leverage. The definition of Total Liquidity includes marketable securities, which are highly liquid and available to use in our current operations.

Consolidated Statement of Operations(unaudited, in thousands, except per share data)

Consolidated Balance Sheets(unaudited, in thousands)

Consolidated Cash Flow Statement(unaudited, in thousands)

Adaptimmune Contacts:

Media Relations:

Sbastien Desprez VP, Communications and Investor RelationsT: +44 1235 430 583M: +44 7718 453 176Sebastien.Desprez@adaptimmune.com

Investor Relations:

Juli P. Miller, Ph.D. Senior Director, Investor RelationsT: +1 215 825 9310M: +1 215 460 8920Juli.Miller@adaptimmune.com

1 Total liquidity is a non-GAAP financial measure, which is explained and reconciled to the most directly comparable financial measures prepared in accordance with GAAP below.

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Adaptimmune Reports Fourth Quarter / Full Year 2019 Financial Results and Business Update - GlobeNewswire

Rheumatoid Arthritis Stem Cell Therapy Market Key Development by 2025 – News Times

By Stem Cell Treatment

As per a report Market-research, the Rheumatoid Arthritis Stem Cell Therapy economy is likely to see a CAGR increase of XX% within the forecast period (2019-2029) and reach at a value of US$ at the ending of 2029. The macro economic and micro elements which are predicted to influence the trajectory of this market are examined from the market analysis that was presented.

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Rheumatoid Arthritis Stem Cell Therapy Market Key Development by 2025 - News Times

Common sources of shoulder pain and how to treat it – Summit Daily News

By Platelet Rich Plasma Injections

Editors Note: Sponsored content brought to you by Panorama Summit Orthopedics

Shoulder pain can range from temporary to long-lasting, from motion-related to constant, but one of the most disruptive symptoms of any shoulder injury is its effect on sleep.

When you dont sleep, everything in life becomes harder, said Dr. Aaron Black, a shoulder, knee and trauma specialist at Panorama Summit Orthopedics.

Some of the most common sources of shoulder pain include rotator cuff injuries and arthritis. In Summit County, its common to see patients who develop shoulder arthritis as a result of previous injuries to the shoulder, such as a shoulder dislocation earlier in life, Dr. Black said.

A specific diagnosis and treatment plan can result in years or perhaps a lifetime of pain relief and increased mobility in this important joint. Its Dr. Blacks mission to make sure hes helping patients not only eliminate shoulder pain and weakness, but also get back to consistently healthy and restful sleep.

Primary arthritis vs. rotator cuff arthropathy

The two broad categories of arthritis most commonly seen in Summit County are primary arthritis and rotator cuff arthropathy, or secondary arthritis. Primary arthritis has no specifically known cause and is usually related to age, sex and genes, according to the Arthritis Foundation. Rotator cuff arthropathy happens after a large, long-standing rotator cuff tendon tear that no longer holds the head of the humerus in the socket, causing it to move upward and damage the surface of the bones, according to the American Academy of Orthopaedic Surgeons.

Shoulder arthritis is experienced as achy pain and stiffness around the shoulder that often feels worse in the morning, Dr. Black said. Rotator cuff arthropathy is usually associated with stiffness and weakness.

Nonoperative arthritis treatment

Nonoperative shoulder arthritis treatment includes physical therapy and injection therapies.

As with any arthritic joint, the more you use it, the less stiff it is and the less pain you have, Dr. Black said.

PT can help improve range of motion in the shoulder, while icing the shoulder two or three times a day can reduce inflammation and ease pain.

Dr. Blacks injection therapy options include cortisone and biologic agents, such as platelet-rich plasma (PRP), all of which act primarily as anti-inflammatories.

No biologic injection therapies contain stem cells for tendons or cartilage, despite advertisements to the contrary, and thus do not regrow cartilage or tendons, he said.

Cortisone injections can offer pain relief for three to six months, while PRP tends to last a bit longer, Dr. Black said. The procedures are performed in the office under ultrasound guidance.

Shoulder joint replacement (arthroplasty)

If shoulder arthritis is severe, its less likely that the nonoperative options will get the job done. The next option for these patients would be shoulder joint replacement surgery.

Dr. Black said there are two types of shoulder replacements: anatomic total shoulder replacement and reverse total shoulder replacement. There are roughly 53,000 of these surgeries performed each year in the United States, according to the American Academy of Orthopaedic Surgeons.

Both procedures have differing benefits. Dr. Black said that anatomic replacements can be done on patients of any age, but those who have it at a younger age might require another surgery later in life. The procedure works well for getting patients back to their normal activities.

Reverse replacements are extremely reliable for reducing or eliminating pain, but less reliable for getting full range of motion back, he said.

I do all of my shoulder replacements with custom 3D modeling and patient-specific guides made to ensure the components are in exact right position, Dr. Black said.

Dr. Black stresses that all joint replacements are elective surgeries.

I will never tell a patient they have to have a joint replacement, he said. This is symptom-based when you say its time, its something Ill say you should have. I want all of my patients to be informed about the options.

Shoulder joint replacement recovery includes about six weeks in a sling, and in three to four months most patients are back to regular activity with continued improvement from there.

Rotator cuff injuries

Another common local shoulder affliction is to the rotator cuff, which is the combination of muscles and tendons that keep your arm bone centered in your shoulder socket to provide shoulder motion and stability. Dr. Black said these injuries can happen during a fall when the arm is thrown away from the body, but sometimes rotator cuff injuries are chronic and happen over time.

Some people even have large tears to the rotator cuff without ever feeling any symptoms.

The good news is that there are a lot of treatment options, from physical therapy and injections to repair or reconstruction surgery.

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Common sources of shoulder pain and how to treat it - Summit Daily News

HEALTHBEAT 4: Alternatives to surgery – KTIV

By Platelet Rich Plasma Injections

SIOUX CITY (KTIV) -- Incisions. It's something you commonly think of when it comes to doctors.

But, many look to put down the scalpel and take an alternative approach.

"Most of the patients that come to my clinic, don't end up getting a surgery," CNOS Orthopedic Sports Surgeon Dr. Ben Bissell said.

Dr. Ben Bissell is an Orthopedic Sports Surgeon with CNOS. He said while there are many cases where surgery is the best option for patients.

"Acute ACL tear with meniscus tears and a locked knee in a young athlete, that particular issue just need surgery," Dr. Bissell said.

He said they always try to look for alternatives. To them, the most important thing is getting the correct diagnosis.

"The most important thing is to do a careful history and physical exam and X-rays and/or MRI if needed because every diagnosis has different treatment options," Dr. Bissell said. "It's important that we don't use a one size fits all approach."

Options like bracing, medications, physical therapy, platelet-rich plasma injections, or dry needling.

"I find kind of the area of dysfunction or sometimes people call it a knot," CNOS Physical Therapist Alex Tritz said. "I put the needle right into that area and then I piston it around to try and find a twitch. Then I use electric stimulation a lot with my needling. So I usually hook up to electric stimulation and I make the muscle twitch."

Tritz said many of the people she sees have chronic or acute pain. Many coming to her with sports-related injuries.

"Usually it's kind of to prevent surgery or a lot of times it's a last-ditch effort," Tritz said. "People that have had a lot of or have even had previous surgeries and they didn't get relief, this is kind of their last-ditch effort and I usually get pretty good results."

"I think in general the less invasive, more conservative approach is always best to try first," Bissell said. "Because it's less disruptive to their lives. It's less expensive and it's less risky."

Dr. Bissell said he always tells patients that "Plan A" is to try and avoid surgery and while 70 to 90 percent of patients he initially sees, don't need surgery, that can change.

He said some may need it after a year or two if the other options haven't worked.

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HEALTHBEAT 4: Alternatives to surgery - KTIV

CAR T Cells to Go? Outpatient Therapy Can Be Safe – Medscape

By Stem Cell Medical Center

ORLANDO, Florida Chimeric antigen receptor (CAR) T-cell therapy can be safely delivered in the outpatient setting, which could make the life-extending treatment available to patients who don't have access to a major teaching hospital or treatment center, contend investigators who analyzed data from three clinical trials.

Looking at outcomes for patients with large B-cell lymphomas (LBCL) who were treated with the CAR T-cell construct lisocabtagene maraleucel (liso-cel) in the outpatient setting at both university-based and nonacademic medical centers in three clinical trials, Carlos Bachier, MD, from the Sarah Cannon Blood Cancer Network in Nashville, Tennessee, and colleagues found that the incidences of severe adverse events were relatively low and manageable.

"Outpatient administration of liso-cel and subsequent monitoring were successfully implemented in multiple clinical trials at both university and nonuniversity sites," he said here at the Transplantation and Cellular Therapy annual meeting.

Dr Carlos Bachier

The need to monitor and treat serious side effects from CAR T therapy, such as the cytokine release syndrome (CRS) and neurologic toxicities, has previously limited the therapy to major treatment centers with extensive resources. Yet most patients in the US with relapsed or refractory large B-cell non-Hodgkin lymphoma are treated at nonacademic centers where cancer therapies are typically delivered in outpatient infusion centers, Bachier said.

"Infusion and monitoring of patients receiving CAR T-cell therapy in the outpatient setting can lead to wider utilization and improved access," he said.

To get a better idea of the safety and efficacy of CAR T-cell therapy in the outpatient setting, Bachier and colleagues examined outcomes from the phase 1 TRANSCEND NHL 001 trial of liso-cel in one or two doses for a variety of aggressive lymphoma histologies, conducted in both university-based and nonuniversity centers; the phase 2 TRANSCEND-OUTREACH trial of outpatient liso-cel therapy after two or more prior lines of therapy against various lymphomas and lymphoproliferative disorders, conducted in nonuniversity centers; and the phase 2 TRANSCEND-PILOT-017006, testing liso-cel in patients with LBCL relapsed or refractory after a single line of immunochemotherapy who were ineligible for either high-dose chemotherapy or stem cell transplant. This trial was conducted in both university and nonuniversity settings.

In OUTREACH and PILOT, liso-cel was administered at a dose of 100 x 106 CAR-positive T cells; in TRANSCEND, it was given at doses of 50, 100, or150 x 106.

To qualify for outpatient administration and monitoring, both university centers and nonuniversity specialty oncology centers had to have at least hematopoietic stem cell therapy (HSCT) or phase 1 trial capability, an outpatient infusion center or inpatient infusion unit with same-day discharge; an affiliated aphereseis center; and a multidisciplinary medical team that can coordinate care between inpatient and outpatient settings, have standard operating procedures for outpatient monitoring and admissions when necessary, and an oncologist on call at all times.

In addition, each center had to have one designated hospital for care of CAR T-cell recipients with staff trained to manage typical CAR T-cell toxicities and a ready supply of tocilizumab (Actemra, Genentech) for treating CRS.

For their part, patients needed to have caregiver support and stay within 1 hour travel of the treatment center for the first 30 days after infusions, had to commit to returning to the site for immediate medical evaluation as necessary, and had to be educated about the early signs and symptoms of CRS and neurologic toxicities.

The analysis included data on 44 patients with a median age of 62 years (range 24 to 82), including 25 enrolled in TRANSCEND, 13 in OUTREACH, and 6 in PILOT. Eighteen patients were age 65 or older, 12 had high tumor burden, and 6 had lactate dehydrogenase (LDH) levels of 500 U/L or higher.

Treatment-related adverse events (TEAEs) occurring in at least 25% of outpatients were similar to those among all patients in TRANSCEND, with the most frequent grade 3 or 4 events being neutropenia, anemia, and thrombocytopenia. There were no treatment-related deaths among those monitored as outpatients.

CRS of any grade occurred in 12 of 25 outpatients (48%) in TRANSCEND, in 5 of 13 (38%) in OUTREACH, and in none of the 6 outpatients in PILOT. Grade 3 or 4 CRS was seen in 1 outpatient in TRANSCEND, but in none of the other patients in the other two trials.

Grade 3 or 4 neurologic events occurred in two outpatients in TRANSCEND, but were not seen in any outpatients in OUTREACH or PILOT.

Three patients in TRANSCEND and two in OUTREACH received either tocilizumab or corticosteroids for CRS, and five patients in TRANSCEND received corticosteroids for neurologic adverse events. Prolonged grade 3 or greater cytopenias were seen in three patients in TRANSCEND, five in OUTREACH, and one in PILOT.

The median onset of CRS was 5 days, and the median onset of neurologic toxicities was 8 days among all outpatients, and was similar to combined inpatient and outpatient population in TRANSCEND. The median duration of the events 6 days for CRS, 16 days for neurologic events was also similar to that seen in TRANSCEND.

Of the 44 patients from all three trials, 24 (55%) were hospitalized after liso-cel administration, for a median of 6.5 days (range 2-23). The median time to hospitalization was 5 days. One third of the hospitalizations were for either CRS or neurologic events. There were 2 cases of ICU admissions after liso-cel administration, for a median ICU stay of 4 days.

In all, 45% of outpatients did not require hospitalization, and there was no increase in ICU admissions compared with inpatients, Bachier pointed out.

The overall response rate was 80%, with a complete response rate of 55%, similar to that seen in TRANSCEND, he said.

In an interview with Medscape Medical News seeking objective commentary on the findings, Yago Nieto, MD, from the University of Texas MD Anderson Cancer Center in Houston, said that he would be comfortable with CAR T-cell therapy in the outpatient setting, provided that several key components of care are in place.

"It requires an organized effort to be able to see those patients in an outpatient clinic weekdays and weekends, having every contingency discussed beforehand, including for ICU team members to admit patients into the ICU if necessary which is unusual, particularly with liso-cel but it has to be all worked out in advance in a multidisciplinary effort," he said.

Nieto comoderated the session where the data were presented, but was not involved in the study.

Comoderator Mazyar Shadman, MD, MPH, from the Fred Hutchinson Cancer Research Center in Seattle, Washington, who was not involved in the study, told Medscape that his center treats patients with CAR T therapy in the outpatient setting.

"But it's important to know that when you talk about outpatient care, it's not your outpatient clinic where you see patients once a week," he said. "These are intensive outpatient centers. We have a team that's just outpatient, but we see these patients on a daily basis, we have dedicated nurses and practitioners, and we have labs and immunotherapy services for getting results quickly."

"I feel comfortable giving CAR T therapy to a patient in this setting," he added, "but not to a patient being treated in the middle of nowhere."

The study was funded by Juno Therapeutics, a Bristol-Myers Squibb company. Bachier disclosed advisory board activities for various companies, not including Juno or BMS. Nieto disclosed research funding and consultancy for various companies not including the sponsors of this study. Shadman disclosed research funding, honoraria, and consultancy with various companies not including Juno or BMS.

Transplantation & Cellular Therapy Meetings of ASTCT and CIBMTR 2020: Abstract29. Presented February 19, 2020.

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CAR T Cells to Go? Outpatient Therapy Can Be Safe - Medscape

TO YOUR HEALTH: Inflammation can drive triple-negative breast cancer – Dover Post

By Stem Cell Medical Center

Study at ChristianaCare Cawley Center for Translational Cancer Research

While radiation is successfully used to treat breast cancer by killing cancer cells, inflammation caused as a side-effect of radiation can have a contrary effect by promoting the survival of triple-negative breast cancer cells, according to research published online in the International Journal of Radiation Biology by Jennifer Sims-Mourtada, Ph.D., director of Translational Breast Cancer Research at ChristianaCares Helen F. Graham Cancer Center & Research Institute.

Accounting for 15-20% of all breast cancers, triple-negative breast cancer is faster growing than other types.

Sims-Mourtadas latest study, Radiation induces an inflammatory response that results in STAT3-dependent changes in cellular plasticity and radioresistance of breast cancer stem-like cells, brings scientists closer to understanding the mechanisms behind this aggressive and hard-to-treat cancer. It shows that inflammation caused by radiation can trigger stem-cell-like characteristics in non-stem breast cancer cells.

This is the good and the bad of radiation, Sims-Mourtada said. We know radiation induced inflammation can help the immune system to kill tumor cells thats good but also it can protect cancer stem cells in some cases, and thats bad.

She added, Whats exciting about these findings is were learning more and more that the environment the tumor is in its microenvironment is very important. Historically, research has focused on the genetic defects in the tumor cells. Were now also looking at the larger microenvironment and its contribution to cancer.

The term triple-negative breast cancer refers to the fact that the cancer cells dont have estrogen or progesterone receptors and also dont make too much of the protein called HER2. The cells test negative on all 3 tests. These cancers tend to be more common in women under age 40, who are African-American, Latina or who have a BRCA1 mutation.

My work focuses on cancer stem cells and their origination, Sims-Mourtada said. They exist in many cancers, but theyre particularly elusive in triple-negative breast cancer. Their abnormal growth capacity and survival mechanisms make them resistant to radiation and chemotherapy and help drive tumor growth.

She and her team applied radiation to triple-negative breast cancer stem cells and to non-stem cells. In both cases, they found radiation induced an inflammatory response that activated the Il-6/Stat3 pathway, which plays a significant role in the growth and survival of cancer stem cells in triple-negative breast cancers. They also found that inhibiting STAT3 blocks the creation of cancer stem cells. As yet unclear is the role IL-6/STAT3 plays in transforming a non-stem cell to a stem-cell.

For women living in Delaware, Sims-Mourtadas research is especially urgent: The rates of triple-negative breast cancer in the state are the highest nationwide.

At ChristianaCare, we are advancing cancer research to help people in our community today, while we also advance the fight against cancer nationwide, said Dr. Nicholas J. Petrelli, Bank of America endowed medical director of the Helen F. Graham Cancer Center & Research Institute. Dr. Sims-Mourtadas research is a dramatic step toward better treatments for triple-negative breast cancer.

To advance her research on inflammation, last year Sims-Mourtada received a $659,538 grant from the Lisa Dean Moseley Foundation. The three-year grant will enable her and her team at the Cawley Center for Translational Cancer Research to continue investigating the role of cells immediately around a tumor in spurring the growth of triple-negative breast cancer and a possible therapy for this particularly difficult cancer.

Our next step is to understand the inflammatory response and how we might inhibit it to keep new cancer stem cells from developing, Sims-Mourtada said.

Sims-Mourtadas research team previously identified an anti-inflammatory drug, currently used to treat rheumatoid arthritis, that has the potential to target and inhibit the growth of cancer stem cells and triple-negative breast cancer tumors. That research could set the stage for clinical investigation of the drug, alone or in combination with chemotherapy, to improve outcomes for patients with triple-negative breast cancer.

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TO YOUR HEALTH: Inflammation can drive triple-negative breast cancer - Dover Post

Family Doctors: Their Role, Education and Responsibilities – The Hear UP

By Stem Cell Doctors

Autism spectrum disorder (ASD) is becoming a growing concern across the nation for doctors and caregivers alike.

Recent statistics provided by the Centers for Disease Control and Prevention (CDC) indicate that 1 out of 150 kids display the symptoms of this affliction in the United States alone. The surging number of ASD cases across the nation has spurred the medical community to find and prescribe suitable treatment solutions that are viable and safe for children.

The last decade has witnessed a sharp increase in the use of HBOT for autism relied on. Initiating the right treatment methods such as HBOT for autism-related issues in the early stages is proving to be a life-saver for several kids ailing from this disorder.

Autism spectrum disorder (ASD) is a neurodegenerative condition that can significantly affect the cognitive functions of a child. Kids with ASD are known to experience challenges whilst communicating or engaging in simple day-to-day activities.

Autistic kids often struggle with basic issues such as:

These conditions are visible in kids from a nascent stage. Any delay in providing adequate treatment post the initial diagnosis can result in the children behaving erratically or turn reclusive.

The most commonly reported symptoms in patients with ASD are:

Medical experts attribute the causes of autism to varied factors.

A few have been listed herewith:

However, clarity on the veracity of these claims remains unfounded and efforts by researchers to unravel the actual causes of autism are still ongoing.

Medical experts treating cases of autism are increasingly recommending HBOT for autism-related complications.

Hyperbaric researchers recently conducted a randomized, controlled study on a group of 62 autistic kids aged between 2 to 7 and the results have been quite encouraging.

The children underwent 40 hours of hyperbaric therapy for four weeks. The following observations were recorded by the research team post the HBOT program:

Pure oxygen, an integral element of HBOT, has been used by physicians for centuries to provide relief to individuals ailing from a range of health disorders.

During the early 1960s, doctors in the US Navy used hyperbaric oxygen therapy (HBOT) to provide relief to deep-sea divers for decompression sickness.

Gradually, hyperbaric experts realized that this alternative therapy could also be applied to treat varied ailments such as:

Apart from these above-mentioned FDA approved conditions, researchers discovered that HBOT can be successfully used to treat patients with an autism spectrum disorder.

As medical professionals claim that ASD is linked to pre-dominantly low levels of oxygen in the body, hyperbaric therapy is being widely recommended by specialists, as an ideal treatment program for autistic patients.

During the HBOT process, the autistic child is placed into a hyperbaric chamber and administered pressurized pure oxygen at levels that are 1.2 to 3 times greater than normal atmospheric pressure.

The pressurized oxygen instantly dissolves into the body fluids of the child and boosts the oxygen-rich plasma to all the parts of the brain that are affected due to the reduced blood-oxygen levels. The surge of oxygen-rich plasma stimulates the dormant neurons in the brain and activates fresh cell regeneration.

Hyperbaric experts have observed a significant improvement in the autistic patients condition post undergoing regular HBOT.

Cerebral hypoperfusion is linked to repetitive behavior, affected facial expressions and distorted speech patterns.

Autistic kids have displayed a marked increase in their cerebral perfusion levels post HBOT.

Oxidative stress is known to reduce antioxidant enzymes that are vital for brain health. Patients have recorded healthy antioxidant enzyme levels post undergoing hyperbaric therapy.

Neuro-inflammation, gastrointestinal inflammation, and immune dysregulation are serious conditions that occur due to abnormal cytokine levels, leading to health setbacks such as disruptive behavior, inflammatory bowel disease, and chronic diarrhea.

Autistic kids undergoing HBOT have experienced substantial relief in their condition post hyperbaric therapy as this alternative treatment is known to regulate cytokine production.

ASD is known to cause mitochondrial dysfunction in children. A few related complications such as higher CSF lactate levels, decreased cerebral blood flow and brain oxygen levels are potential health hazards that disrupt the patients overall well-being.

Controlled studies conducted by hyperbaric researchers have revealed that HBOT aids in elevating both the brain oxygen level and cerebral blood flow. A decrease in the CSF lactate levels have also been observed in the patients post the therapy.

The current success rate of HBOT for autism relief is definitely enabling kids to dream of leading a healthy life by effectively countering and overcoming this debilitating disorder.

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Family Doctors: Their Role, Education and Responsibilities - The Hear UP

Stem Cell Therapy for Coronavirus Infection – Benzinga

By Stem Cell Treatment

GOLDEN, CO / ACCESSWIRE / February 27, 2020 /Vitro Diagnostics, Inc. (OTCPK:VODG), dba Vitro Biopharma reports on a potential therapy of Coronavirus (COVID-19) infections by stem cell transplant. While this therapy is not a method to eradicate or cure Coronavirus, there is evidence to support the concept that infected patients may be more likely to combat and survive infection. First, stem cells resist viral attack by the expression of certain genes known as interferon gamma stimulated genes (ISGs). These are expressed in stem cells prior to their differentiation. (Wu, X, et al, Cell 172: 423, 2018). Hence, stem cells would be expected to survive even if transplanted into a patient with an active Coronavirus infection. Also, it is known that stem cells rejuvenate and regenerate cells in the body through various processes involving reduction of inflammation, secretion of substances that protect cells, transfer of mitochondria, reduction of cell death, anti-oxidative effects and improvement of immune system function. These effects are likely to increase survival in patients infected with Coronavirus. Also, there is direct evidence of stem cell protection against viral infection. Influenza virus A/H5N1 causes acute lung injury that was reduced by human mesenchymal stromal cells (MSCs) in mice and the treatment increased survival (Chan, et al, PNAS 113:3621, 2016).

Vitro Biopharma has operated a highly regulated, FDA-compliant commercial biologics manufacturing facility for several years and is cGMP compliant, ISO9001 Certified, ISO13485 Certified, CLIA Certified and FDA registered. All clinical manufacturing occurs in a certified sterile clean room with extensive and advanced testing to assure the absence of contamination. Furthermore, in numerous patients treated to date by IV infusion of our AlloRx Stem Cells there have been no significant adverse events while we have gained evidence of efficacy. We presently supply our AlloRx Stem Cells to DVC Stem in the Cayman Islands for treatment of inflammatory conditions. We plan to begin recruitment of patients for a trial of stem cell therapy of musculoskeletal conditions in the Bahamas during spring 2020.

Dr. Jim Musick, CEO said, "We are pleased to be positioned to offer stem cell therapy for Coronavirus infection. While there are several factors related to the possible extent of this global infection, stem cell therapy represents a therapeutic option to fight the virus and increase survival while effective vaccines are being developed. Our existing off-shore partners offer stem cell transplant services and we are in contact with CDC officials regarding potential US-based stem cell transplants into infected individuals."

About Vitro Biopharma

Vitro Biopharma, for over 10 years, has supplied major biopharmaceutical firms, elite university laboratories and clinical trials worldwide with Mesenchymal Stem Cells, the MSC-Grow Brand of cell culture media, various stem cell derivatives and stem cell-derived differentiated cells. We also manufacture primary fibroblast cells and an expanding line of cancer-associated fibroblasts (CAFs) from various tumors including lung, breast, melanoma, pancreatic, glioblastoma and colorectal tissues. Our CAFs are purchased by major pharmaceutical and biopharmaceutical firms to advance immunotherapy of cancer.

Out of our 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. We are supporting clinical studies of stem cell therapies using our AlloRx Stem Cells for osteoarthritis, neurodegenerative diseases including Parkinson's disease, Multiple Sclerosis and Alzheimer's disease while pursuing select US markets for stem cell therapies.

We support our regenerative therapies with NutraVivo/STEMulize, a nutraceutical Stem Cell Activator that has been shown to induce proliferation, migration and epigenetic modification of human adult stem cells. NutraVivo improves overall cellular wellness and significantly increases expression of anti-aging genes.

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. James MusickChief Executive OfficerVitro Biopharma(303) 999-2130 Ext. 1E-mail: jim@vitrobiopharma.com

SOURCE: Vitro Diagnostics, Inc.

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Stem Cell Therapy for Coronavirus Infection - Benzinga

New technique developed to treat hardening of internal organs – WNDU-TV

By Stem Cell Treatment

There is new hope for patients with a rare autoimmune disorder. In mild cases, scleroderma causes areas of hardened skin. But in severe cases, it can also cause deadly hardening of internal organs like the lungs.

A transplant typically used to treat cancer is having remarkable results for patients who had little hope of surviving.

A year ago, Chuck Beschta couldn't walk more than a few minutes without stopping to rest.

"Just going out and doing normal activities outside raking the lawn, mowing the grass, shoveling the driveway, whatever, snow blowing those became impossible," he said.

After months of testing, he was diagnosed with severe scleroderma, which was hardening his skin. But even worse, it was hardening his lungs, making it hard to breathe.

"He was getting worse despite the best therapy we had to offer," University of Wisconsin rheumatologist Dr. Kevin McKown said.

McKown recommended a stem cell transplant newly approved for scleroderma to reboot Beschta's immune system.

"There's a process by which they try to remove the autoreactive immune cells, the cells that are caught in the immune process, and then they infuse that back in and hope that the body will basically take up and graft that immune system," McKown said.

Beschta saw almost immediate results. His skin was softer and his breathing improved. He hopes his scleroderma has been cured.

"I think we can be optimistic, and so far the people who have been followed out as far as 10 years out don't seem to be getting it back," McKown said.

Without a transplant, less than half the patients who have diffuse scleroderma and severe lung disease live 10 years past diagnosis.

Stem cell transplants are commonly used to treat leukemia and lymphoma, cancers that affect the blood and lymphatic system.

MEDICAL BREAKTHROUGHSRESEARCH SUMMARYTOPIC: NEW THERAPY FOR SCLERODERMAREPORT: MB #4698

BACKGROUND: Scleroderma is an autoimmune rheumatic disease where an overproduction of collagen produced in the body tissues causes the skin and internal organs to harden. The symptoms and effects range by person, but some common symptoms include hardened patches of skin (locations on the body vary,) painful and numb-feeling fingers and toes, and sharp internal pain in the esophagus, intestines, heart, lungs, or kidneys. Women are four times as likely to have scleroderma and the onset is between 30 and 50 years of age. However, anyone from infants to the elderly can have scleroderma. Possible risk factors include having certain gene variations as other family members, ethnic groups, exposure to certain medications or drugs, and already having another autoimmune disease, like rheumatoid arthritis, lupus or Sjogren's syndrome. (Source: https://www.scleroderma.org/site/SPageNavigator/patients_whatis.html;jsessionid=00000000.app30132b?NONCE_TOKEN=9B76519DF6B5819859319F0B63B805C9#.XheCGVVKhaQ , https://www.mayoclinic.org/diseases-conditions/scleroderma/symptoms-causes/syc-20351952 )

DIAGNOSING: A physical exam will be conducted as well as a blood test to check for elevated levels of antibodies the immune system produced. The doctor will also take a sample of skin to be tested in the lab. If there are complaints about internal pain, the doctor may run other tests, including imaging, organ function, and other blood tests. (Source: https://www.mayoclinic.org/diseases-conditions/scleroderma/diagnosis-treatment/drc-20351957 )

NEW TECHNOLOGY: A new stem cell transplant that's commonly known to treat cancer is improving the quality and quantity of life for those with scleroderma. Rheumatologists at University of Wisconsin Health tested the treatment since they have already been conducting bone marrow transplants for decades. Surgeons take out a sample of the patient's bone marrow, isolate the stem cells, and use radiation and chemotherapy to clean out their immune system. The same stem cells are later injected back into the patient's immune system with the hope that new cells will grow and the system is rid of the bad ones. The process is dangerous when the cells are taken out because the patient's immune system is more vulnerable, making infections more likely to occur. However, after four and a half years, 79% of patients that underwent the treatment were alive without serious complications compared to 50% that were treated with the original drugs. (Source: https://madison.com/wsj/news/local/health-med-fit/man-with-severe-autoimmune-disease-gets-stem-cell-transplant-at/article_7e8e17a5-21da-52f8-b728-fe584dab2b77.html)

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New technique developed to treat hardening of internal organs - WNDU-TV

Cells carrying Parkinson’s mutation could lead to new model for studying disease – University of Wisconsin-Madison

By Stem Cell Treatment

Parkinsons disease researchers have used gene-editing tools to introduce the disorders most common genetic mutation into marmoset monkey stem cells and to successfully tamp down cellular chemistry that often goes awry in Parkinsons patients.

The edited cells are a step toward studying the degenerative neurological disorder in a primate model, which has proven elusive. Parkinsons, which affects more than 10 million people worldwide, progressively degrades the nervous system, causing characteristic tremors, dangerous loss of muscle control, cardiac and gastrointestinal dysfunction and other issues.

Marina Emborg

We know now how to insert a single mutation, a point mutation, into the marmoset stem cell, says Marina Emborg, professor of medical physics and leader of University of WisconsinMadison scientists who published their findings Feb. 26 in the journal Scientific Reports. This is an exquisite model of Parkinsons. For testing therapies, this is the perfect platform.

The researchers used a version of the gene-editing technology CRISPR to change a single nucleotide one molecule among more than 2.8 billion pairs of them found in a common marmosets DNA in the cells genetic code and give them a mutation called G2019S.

In human Parkinsons patients, the mutation causes abnormal over-activity of an enzyme, a kinase called LRRK2, involved in a cells metabolism. Other gene-editing studies have employed methods in which the cells produced both normal and mutated enzymes at the same time. The new study is the first to result in cells that make only enzymes with the G2019S mutation, which makes it easier to study what role this mutation plays in the disease.

The metabolism inside our stem cells with the mutation was not as efficient as a normal cell, just as we see in Parkinsons, says Emborg, whose work is supported by the National Institutes of Health. Our cells had a shorter life in a dish. And when they were exposed to oxidative stress, they were less resilient to that.

The mutated cells shared another shortcoming of Parkinsons: lackluster connections to other cells. Stem cells are an especially powerful research tool because they can develop into many different types of cells found throughout the body. When the researchers spurred their mutated stem cells to differentiate into neurons, they developed fewer branches to connect and communicate with neighboring neurons.

We can see the impact of these mutations on the cells in the dish, and that gives us a glimpse of what we could see if we used the same genetic principles to introduce the mutation into a marmoset, says Jenna Kropp Schmidt, a Wisconsin National Primate Research Center scientist and co-author of the study. A precisely genetically-modified monkey would allow us to monitor disease progression and test new therapeutics to affect the course of the disease.

The concept has applications in research beyond Parkinsons.

We can use some of the same genetic techniques and apply it to create other primate models of human diseases, Schmidt says.

The researchers also used marmoset stem cells to test a genetic treatment for Parkinsons. They shortened part of a gene to block LRRK2 production, which made positive changes in cellular metabolism.

We found no differences in viability between the cells with the truncated kinase and normal cells, which is a big thing. And when we made neurons from these cells, we actually found an increased number of branches, Emborg says. This kinase gene target is a good candidate to explore as a potential Parkinsons therapy.

This research was supported by grants from the National Institutes of Health (R24OD019803, P51OD011106 and UL1TR000427).

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Cells carrying Parkinson's mutation could lead to new model for studying disease - University of Wisconsin-Madison

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