Category Archives: Stem Cell Medicine

Engineer the future of human health with a PhD in biomedical engineering – Study International News

Technological advancements have paved the way for many important breakthroughs in biomedical engineering. New methods are being developed, as are our understanding, diagnosing and treating of medical conditions.

Unsurprisingly, the job outlook for biomedical engineers looks promising. The US Bureau of Labor Statistics notes that employment of biomedical engineers is projected to grow four percent from 2018 to 2028, about as fast as the average for all occupations. It adds that the increasing number of technologies and applications to medical equipment and devices, along with the medical needs of a growing and ageing population, will further require the services of biomedical engineers.

If youre trained in biomedical engineering or are a graduate in a related field looking to enhance your qualifications or progress into a leadership role, you may want to consider enroling in doctoral studies in biomedical engineering.

A good place to start is Michigan State University (MSU), which has carved itself a strong reputation in the field.

Its Biomedical Engineering Department (BME) offers a competitive research-oriented doctoral programme with flexible and personalised curricula.

The department is housed in a state-of-the-art research facility and engages with faculty across several disciplines, departments and colleges to explore the intersection of medicine, human biology and engineering.

The BME department is housed within a new research facility, the Institute for Quantitative Health Science and Engineering (IQ). IQ consists of seven research divisions, i.e. biomedical devices, biomedical imaging, chemical biology, developmental and stem cell biology, neuroengineering, synthetic biology and systems biology.

The interdisciplinary research centre is devoted to basic and applied research at the interface of life sciences, engineering, information science and other physical and mathematical sciences.

Students have access to the stellar facilities and equipment at IQ, which foster extensive collaboration between researchers from different areas to solve some of the worlds most challenging biomedical problems.

This systems approach to biomedical research look set to lead to discoveries that are the first of their kind. IQ is connected to both the Clinical Center and Life Sciences buildings, establishing a biomedical research hub at MSU that holds the potential to transform medicine.

The BME department also boasts a range of expertise, including advanced imaging methods and nanotechnology in biomedical research.

Training PhD students in the biodesign process is a priority here whereby students identify significant needs for new biomedical technologies before developing commercialisable technologies that meet those needs.

MSU also provides a host of services to help students healthcare solutions make it to market.

The MSU Innovation Center houses MSU Technologies, Spartan Innovations and MSU Business CONNECT in support of entrepreneurship, facilitating technology transfer, and providing the educational and financial support to turn doctorate students research technologies into successful businesses.

Another major focus of the BME department is biomedical imaging, including the development of new nanoparticle-based combined imaging and therapeutic technologies. The IQ building has one of the few PET MRI systems in the world.

What differentiates MSU from other institutions is their new, two-semester course sequence on the development and translation of new biomedical technologies to meet clinical needs.

Named BioDesign IQ 1 and 2, these courses train BME PhD students and professional students from the colleges of medicine, law, and business to work together effectively in innovation teams. They shadow doctors, identify unmet medical needs that have significant market potential, prototype new technologies to meet those needs, and then develop intellectual property and a business plan to advance these new technologies towards commercialisation.

Apart from its stellar facilities, the university is also home to faculty with strong expertise.

For instance, inaugural IQ director and BME chairperson Christopher H Contag is a pioneer in molecular imaging and is developing imaging approaches aimed at revealing molecular processes in living subjects, including humans and the earliest markers of cancer. Through advances in detection, professionals in the field can greatly improve early detection of diseases and restoration of health. Contag was previously at Stanford University as a professor in the departments of Pediatrics, Radiology, Bioengineering, and Microbiology and Immunology.

Meanwhile, Dr Mark Worden, BME Associate Chair, has developed several interdisciplinary programmes that integrate research and education. His research on nanostructured biointerfaces and multiphase biocatalysis has resulted in over 10 patents issued or pending on technologies including microbiosensors, bioelectronics and multiphase bioreactors.

Source: Shutterstock

Other faculty members doing trailblazing work in the field include Dr Dana Spence, who is investigating and dening new roles for red blood cells in autoimmune diseases such as Type 1 diabetes and multiple sclerosis; Dr Aitor Aguirre, whose research focuses on investigating regeneration and tissue re-modelling in health and disease; and Dr Ripla Arora, who is working on understanding how hormones influence the uterine luminal and glandular epithelium to modulate receptivity and implantation, to name a few.

In addition to insightful guidance from a faculty of this calibre, PhD students also enjoy 100 percent funding, including stipend, tuition and healthcare. As a graduate student in biomedical engineering, they will have the valuable opportunity to work alongside graduate students from different departments across campus.

Without a doubt, a PhD in biomedical engineering from MSU will prove to be fulfilling endeavour, professionally and personally.

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4 leading North American universities for biomedical engineering

Humanitas MEDTEC School: Where science and biomedical engineering meet

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Engineer the future of human health with a PhD in biomedical engineering - Study International News

GIOSTAR Announces Medical Breakthrough in Biotechnology and Lifesciences To Manufacture Abundant, Safe Red Blood Cells From Stem Cells – Benzinga

GIOSTAR/HEAMGEN has developed and secured patented technology to manufacture lifesaving mature red blood cells from stem cells. The red blood cells are made utilizing a bioreactor that permits the production of mature red blood cells, under strictly controlled conditions, for transfusion therapy and replaces the need for a human blood donor. GIOSTAR/HEAMGEN mature red blood cells are safe and not compromised by inadequate pathogen detection and inactivation of diseases such as hepatitis C, HIV, hepatitis B and syphilis. The red blood cells are O-Negative (Universal Donor) to eliminate incompatibility and allosensitization reactions.

ATLANTA (PRWEB) January 29, 2020

GIOSTAR/HEAMGEN has developed and secured patented technology to manufacture lifesaving mature red blood cells from stem cells. The red blood cells are made utilizing a bioreactor that permits the production of mature red blood cells, under strictly controlled conditions, for transfusion therapy and replaces the need for a human blood donor. GIOSTAR/HEAMGEN mature red blood cells are safe and not compromised by inadequate pathogen detection and inactivation of diseases such as hepatitis C, HIV, hepatitis B and syphilis. The red blood cells are O-Negative (Universal Donor) to eliminate incompatibility and allosensitization reactions. Trauma situations often do not allow for adequate blood typing due to time restrictions, so the GIOSTAR/HEAMGEN red blood cells address that need effectively.

"There are three main problems for blood transfusions," stated Dr. Anand Srivastava, Founder and Chairman of GIOSTAR. "First we have to match the blood type. Second, there's not enough blood available every single time. And third, when we transfer blood from one person to another person, there is always a chance of the transfer of disease."

Watch a feature interview with Dr. Anand Srivastava on The DM Zone with host Dianemarie Collins.

The World Health Organization (WHO) published the first detailed analysis on the global supply and demand for blood in October 2019 and found that 119 out of 195 countries do NOT have enough blood in their blood banks to meet hospital needs. In those nations, which include every country in central, eastern, and western sub-Saharan Africa, Oceania (not including Australasia), and south Asia are missing roughly 102,359,632 units of blood, according to World Health Organization (WHO) goals. While total blood supply around the world was estimated to be around 272 million units, in 2017, demand reached 303 million units. That means the world was lacking 30 million units of blood, and in the 119 countries with insufficient supply, that shortfall reached 100 million units.

The global market opportunity for GIOSTAR/HEAMGEN technology presents not only a profitable and scalable business opportunity but also a significant social and environmental impact. The global market is estimated to be at least $ 85 Billion/year.

GIOSTAR/HEAMGEN has identified early entry global markets to include Military, Trauma, Asia (replace Hepatitis C contaminated blood products), Africa (AIDS contaminated blood), Newborns, Thalassemia patients, Allosensitized sickle cell disease patients. South Sudan was found to have the lowest supply of blood, at 46 units per 100,000 people. In fact, the country's need for blood was deemed 75 times greater than its supply. In India, which had the largest absolute shortage, there was a shortfall of nearly 41 million units, with demand outstripping supply by over 400 percent. Strategic investments are needed in many low-income and middle-income countries to expand national transfusion services and blood management systems. Oncology is a major user of blood transfusion but if countries don't have the capacity to manage the bulk of oncology, it will limit complex surgery options.

GIOSTAR/HEAMGEN has acquired the exclusive license to the patent for the technique for stem cell proliferation from University of California San Diego (UCSD). The founding team of GIOSTAR/HEAMGEN is comprised of the scientists and clinicians who were involved in creating the Intellectual Property at UCSD and has already achieved PROOF OF CONCEPT - the optimized lab scale proliferation of mature red blood cells - at UCSD as part of their research.

GIOSTAR/HEAMGEN is currently looking for strategic partnerships (Contact Doug@DMProductionsLLC.com) to accelerate the development of donor-independent red blood cells manufacturing capabilities and advance the proof of concept work already done (patented) around the manufacture of safe, universal donor, human red blood cells. GIOSTAR/HEAMGEN will also develop a full automated proprietary bioreactor using robotic technology to produce abundant quantities of red blood cells with a goal for cost-effective commercialization of fresh, human, universal donor Red Blood Cells (RBCs).

ABOUT GIOSTAR

Dr. Anand Srivastava is a Chairman and Cofounder of California based Global Institute of Stem Cell Therapy and Research (GIOSTAR) headquartered in San Diego, California, (U.S.A.). The company was formed with the vision to provide stem cell based therapy to aid those suffering from degenerative or genetic diseases around the world such as Parkinson's, Alzheimer's, Autism, Diabetes, Heart Disease, Stroke, Spinal Cord Injuries, Paralysis, Blood Related Diseases, Cancer and Burns. GIOSTAR is a leader in developing most advance stem cell based technology, supported by leading scientists with the pioneering publications in the area of stem cell biology. Company's primary focus is to discover and develop a cure for human diseases with the state of the art unique stem cell based therapies and products. The Regenerative Medicine provides promise for treatments of diseases previously regarded as incurable.

GIOSTAR is world's leading Stem cell research company involved with stem cell research work for over a decade. It is headed by Dr Anand Srivastava, who is a pioneer and a world-renowned authority in the field of Stem Cell Biology, Cancer and Gene therapy. Several governments and organizations including USA, India, China, Turkey, Kuwait, Thailand, Philippines, Bahamas, Saudi Arabia and many others seek his advice and guidance on drafting their strategic and national policy formulations and program directions in the area of stem cell research, development and its regulations. Under his creative leadership, a group of esteemed scientists and clinicians have developed and established Stem Cell Therapy for various types of autoimmune diseases and blood disorders, which are being offered to patients in USA and soon it will be offered on a regular clinical basis to the people around the globe.

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GIOSTAR Announces Medical Breakthrough in Biotechnology and Lifesciences To Manufacture Abundant, Safe Red Blood Cells From Stem Cells - Benzinga

Study suggests Parkinson’s present from birth and may be preventable – New Atlas

Parkinsons disease is an illness that most often affects older people, but new research suggests it may actually be present in the brain right from birth and even earlier. Scientists from Cedars-Sinai have now found that in the brains of young-onset Parkinsons patients, malfunctioning neurons are always there but it takes 20 to 30 years for the symptoms to accumulate. Thankfully, a drug thats already on the market could help prevent the disease from taking hold if caught early enough.

Parkinsons disease primarily affects neurons in the brain that produce dopamine, eventually causing muscle weakness and stiffness, tremors, and balance problems. Most of the time, the disease is diagnosed in older people over the age of 60, but around 10 percent of cases occur in those aged between 21 and 50.

In a new study, scientists from Cedars-Sinai set out to investigate whether there were any early warning signs in the neurons of patients whod been diagnosed with Parkinsons before they turned 50. To do so, they created induced pluripotent stem cells (IPSCs) from young-onset Parkinsons patients, which can then be turned into almost any other cells in the body.

The researchers used the IPSCs to grow dopamine neurons in lab dishes. As they watched them develop, the team noticed that cell structures called lysosomes were malfunctioning. These structures are responsible for breaking down unneeded or worn-out proteins so when they dont work as well as they should, proteins begin to pile up. And one such protein that the team spotted in higher amounts is called alpha-synuclein, which is implicated in many forms of Parkinsons.

"Our technique gave us a window back in time to see how well the dopamine neurons might have functioned from the very start of a patients life, says Clive Svendsen, senior author of the study. "What we are seeing using this new model are the very first signs of young-onset Parkinsons. It appears that dopamine neurons in these individuals may continue to mishandle alpha-synuclein over a period of 20 or 30 years, causing Parkinsons symptoms to emerge.

Next up, the team investigated whether the condition could potentially be treated or even prevented. After testing a series of drugs, they found one that looked promising PEP005, which has already been approved by the FDA for use against skin precancers. The researchers found that PEP005 works to reduce the levels of alpha-synuclein, as well as another abnormally-abundant enzyme called protein kinase C, whose role in Parkinson's remains unclear.

The treatment looks promising, but for now its only been shown to work in mice and lab-grown cells, so it wont necessarily translate to human trials. The team plans to continue working on this, as well as figuring out how to adapt PEP005 for use in the brain at the moment, its only available as a topical gel, since it's for treating skin cancer.

The research was published in the journal Nature Medicine.

Source: Cedars-Sinai

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Study suggests Parkinson's present from birth and may be preventable - New Atlas

Celavie Biosciences Presented Five-Year Follow-Up Data in Parkinsonian Patients at the World Stem Cell Summit – Yahoo Finance

CEO Sandy Solmon to Present on Celavies Stem Cell Therapies at Upcoming Conferences in New York and Barcelona

Celavie Biosciences, LLC, a company working to improve lives and restore hope by advancing innovations in CNS diseases with regenerative stem cell-based therapies, today announced their presentation of a poster, titled "Five year follow-up on the first-in-human transplantation of undifferentiated stem cells into Parkinsonian patients reveals no adverse effects with improvement in motor function or arrest of the disease progression in five out of seven patients," at the Phacilitate Leaders World and World Stem Cell Summit, held January 21-24 in Miami, Florida.

The poster shows five-year follow-up data that expands on the exploratory clinical data in 7 PD patients with four-year follow-up published in Cell Transplantation in 2018. Oleg Kopyov, Executive Vice President and Chief Scientific Officer at Celavie, presented the poster on-site at the Miami Hyatt Regency.

In the results at one year after cell grafting, all but two of the seven patients completing the study showed various degrees of motor improvement, and five of them showed better response to medication. At five-year evaluation, Unified Parkinsons Disease Rating Scale III (UPDRS III) scores remained better than at baseline in 4/7 patients in the OFF condition and in 5/7 patients in the ON condition. None of the patients showed unwanted motor disturbances (dyskinesias), tumor formation, or any detectable immune responses to the grafted cells.

"We are excited that the five-year data for our exploratory clinical trial suggest that the neural progenitor cells are able to stop or slow down the motor deterioration in Parkinsons patients that one would expect to see in this timespan, showing continued improvement even compared to the fourth year," said Oleg Kopyov. "We anticipate filing an IND with the FDA for a Phase I U.S. trial in patients with moderate to advanced Parkinsons disease this year."

In addition, Sandy Solmon, Celavies CEO, will deliver presentations at two upcoming international industry conferences:

Ms. Solmon will discuss Celavies application of the companys human undifferentiated allogeneic pluripotent stem cells in Parkinsons disease, as well as pre-clinical data in cerebellar ataxia and upcoming milestones. To schedule a meeting with Celavie Biosciences at these conferences, please contact: Mary Beth Cicero at mbcicero@lavoiehealthscience.com.

About the World Stem Cell Summit

Produced by the non-profit Regenerative Medicine Foundation (RMF), and in its 15th year, the World Stem Cell Summit will take place January 21-24, 2020, in Miami, Florida in partnership with Phacilitate Leaders World, as part of Advanced Therapies Week. The Summit is the most inclusive and expansive interdisciplinary, networking, and partnering meeting in the stem cell science and regenerative medicine field. With the overarching purpose of fostering translation of biomedical research, funding, and investments targeting cures, the Summit and co-located conferences serve a diverse ecosystem of stakeholders. For more information about the upcoming World Stem Cell Summit in Miami, please visit: http://www.worldstemcellsummit.com.

About Celavie Biosciences

Celavie Biosciences is a privately-held company whose mission is to improve lives and restore hope by advancing regenerative stem cell therapies for the treatment of Parkinsons disease and other disorders of the central nervous system (CNS). The company develops undifferentiated, unmodified allogeneic pluripotent stem cell-based therapies, holds a strong IP portfolio, including 18 issued patents, and has an experienced management team blending expertise in concept and cell technology, product scalability and entrepreneurship. Celavet, a subsidiary, applies the same proprietary technologies for the treatment and prevention of serious veterinary diseases. More information is available at https://www.celavie.com/.

View source version on businesswire.com: https://www.businesswire.com/news/home/20200122005497/en/

Contacts

Hannah MongeonLaVoieHealthScience(617)655-6765hmongeon@lavoiehealthscience.com

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Celavie Biosciences Presented Five-Year Follow-Up Data in Parkinsonian Patients at the World Stem Cell Summit - Yahoo Finance

The Brave New World of Organoids – North Forty News

PHOTO COURTESY OF ROANE STATE COMMUNITY COLLEGE, TN: Typical nervous tissue that can now be grown as organoids in the lab.

Bio Bites

By R. Gary Raham

One of the big scientific news stories of 2019 involved the use of organoids to help fight disease, and to learn more about how embryos build entire human beings from one fertilized egg cell. The term organoids has a science fictiony sound to it. A title like Attack of the organoids wouldnt be out of place in an SF library. Actually, the ability to create specialized tissuelike bundles of brain neurons that hook together to transmit nerve impulsescan raise a few hairs on ones neck. But organoids do hold great promise for curing diseases, broadening our understanding of development, and personalizing medical treatments.

Stem cells allow scientists to build organoids. Stem cells are like major subcontractors produced by embryos to build the various organs and organ systems we depend on. These pluripotent cells (cells that can differentiate in many ways) can produce brain, kidney, lung, intestinal, stomach, and liver tissue. The tissue clumps produced tend to be smallroughly the size of a peapartly because they dont have access to the circulatory system the body uses to provide oxygen and nutrients and remove wastes. Scientists have to provide work-arounds to keep organoids alive and functioning.

One of the amazing things about organoids is that they self-organize into recognizable tissues without input from an entire body. Take brain cells for example. The neurons produced by stem cells link up and form networks that are capable of transmitting nerve impulses like an intact, complete brain. One leading researcher in this field of study is Alysson Muotri, a biologist at University of California San Diego School of Medicine. His website is http://www.medschool.ucsd.edu. He also has a fascinating series of YouTube videos called Building The Brain With Alysson Muotri. Muotri was senior author on a paper in 2019 in Cell Stem Cell. His lab was able to nurture the growth of brain organoids for many months. After four months electrical activity in the organoids began to increase exponentially. By twenty-five weeks, a computer program had a hard time distinguishing between brain wave patterns produced by organoids and pre-term babies.

Brain tissue organoids also hold promise for studying conditions like autism in human beingsa kind of neurological condition marked by differences in learning styles, repetitive motions, and sometimes difficulty with language and communication. The Harvard Stem Cell Institute is also studying how the Zika virus associates with microcephaly (small brain syndrome) during early embryo development.

Someday, scientists may be able to routinely take stem cells from individuals and test the efficacy of drugs on that persons liver cells, for example, to make sure those drugs wont produce harmful or fatal effects.

The brave new world of organoids is comingand not just in the next SF novel you read.

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The Brave New World of Organoids - North Forty News

The Tiny Brain Cells That Connect Our Mental and Physical Health – WIRED

When enlarged under a high-resolution microscope, microglia resemble elegant tree branches with many slender limbs. As they pass by neurons, microglia extend and retract their tiny arm-like protrusions, tapping on each neuron as if to inquire, Are we good here? All okay? Or not okay?as a doctor might palpate a patients abdomen, or check reflexes by tapping on knees and elbows.

Back in 2004, Barres and Stevens were examining how synapses originally come to be pruned to form a healthy brain during early, normal development. Theyd recently discovered that immune molecules known as complement were sending out eat me signals from some brain synapses, and these synapsestagged with a kind of kiss of death signagewere destroyed. Think of the way you click and tag emails that you want deleted from your inbox. Your email servers software recognizes those tags, and when you click on the Trash icon, bing, theyre gone. Thats similar to what Stevens and Barres were seeing happen to brain synapses that were tagged by complement. They disappeared.

What they described happening in the brain, which they reported in the journal Cell in 2007, echoed a similar process that was well-understood to happen in the body. When a cell dies in a bodily organ, or if the bodys immune system senses a threatening pathogen, complement molecules tag those unwanted cells and invaders for removal. Then, a type of white blood cell known as macrophagesGreek for big eatersrecognizes the tag, engulfs the cell or pathogen, and destroys it. In the body, macrophages play a role in inflammation as well as in autoimmune diseases like rheumatoid arthritis and Guillain Barre. When activated, they can mistakenly go too far in their effort to engulf and destroy pathogens and spew forth a slew of inflammatory chemicals that begin to do harm to the bodys own tissue.

Stevens and Barres werent sure what was eating away at these tagged synapses, causing them to disappear in the brain, but Stevens had a hunch that it might have something to do with microglia.

We could see that when microglia sensed even the smallest damage or change to a neuron, they headed, spider-like, in that neurons direction, then they drew in their limbs and morphed into small, amoeba-like blobs, Stevens says. Soon after, those same synapses disappeared. Poof.

Could microglia be the culprit at the center of it all, the macrophage corollary in the brain, responding to eat me signals and pruning the brains circuitry during development? And what if this process was not only taking place in utero? Stevens wondered, when she first saw microglia behaving this way. What if it was also being mistakenly turned back on again later in life, during the teen years, or in adulthoodonly now its a bad thing and microglia are sometimes mistakenly engulfing and destroying healthy brain synapses too?

You can imagine how you could have too many synapses, or not enough synapse connectivity, Stevens says, her hands spreading wide with excitement. And you can imagine, given how our brain works, if that connectivity is even slightly off, that could potentially underlie a range of neuropsychiatric and cognitive disorders.

When she landed at Harvard, Stevens and her postdoc, Dori Schafer, tried to get a closer look at what microglia were up to in the brain. Schafer injected dye into the eyes of mice, which she then traced down from the neurons in the eye nerves and into the brain. This made the brains synapses glow bright fluorescent red. Microglia were stained fluorescent green. If they saw structuresthe synapsesglowing like red, fluorescent lit-up dots inside the bellies of the green microglia, they would know that microglia were eating synapses.

Six months into their efforts, Schafer came running into Stevenss office with photo images flapping in her hand. Theyre in there! she told Stevens. The synapses are inside the microglia! We can see it! It was such a high-five moment, Stevens recalls. Microglia were like tiny little Pac-Men in the brainand brain synapses were in the belly of the Pac-Men! We felt we were on to something really wonderful, really novel. This was deeply important in terms of looking ahead to microglias role in disease.

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The Tiny Brain Cells That Connect Our Mental and Physical Health - WIRED

Organicell Regenerative Medicine Inc. Provides Update On Operations and Financial Reporting Status – GlobeNewswire

MIAMI, Jan. 21, 2020 (GLOBE NEWSWIRE) -- Organicell Regenerative Medicine Inc. (OTCPK:BPSR) (the Company) is pleased to provide shareholders and the investment community with an update on operations since its filing on November 1, 2018 of the Companys Annual Report on Form filing of Form 10-K for the year ended October 31, 2017, as well as the status of becoming fully compliant with SEC reporting obligations.

The Company is diligently working to complete its Quarterly Reports on Form 10-Q for the quarters ended January 31, 2018, April 30, 2018 and July 31, 2018 and its Annual Report on Form 10-K for the year ended October 31, 2018. In August 2019, the Company engaged Marcum LLP as its independent registered public accounting firm. The Company expects these reports to be completed and filed during the first calendar quarter of 2020. Following completion and filing of these reports, the Company expects to promptly proceed to preparation and filing of its Quarterly and Annual Reports for the fiscal year ended October 31, 2019, with the objective of becoming current in its SEC reporting requirements as soon as possible.

Since November 2018, the Company has remained focused on research and development activities and sale and distribution of anti-aging and cellular therapy derived products.

In February 2019, the Company recommenced its efforts to once again operate a perinatal tissue bank processing laboratory in Miami, Florida for the purpose of performing research and development and the manufacturing and processing of anti-aging and cellular therapy derived products. This new laboratory facility became operational in May 2019 and during the same period, the Company began producing products that are now being sold and distributed to its customers.

In addition, the Company has created what it believes is a world class research, medical and scientific advisory team. We believe that our team is one of the most qualified and industry reputable teams assembled to adequately address the current and expected future medical and regulatory challenges facing the Company and overall industry and to provide leadership in the ongoing development of superior quality products for use in the health care industry.

The Company has actively taken steps to assure that it meets compliance with current and anticipated United States Food and Drug Administration (FDA) regulations expected to be enforced beginning in November 2020 requiring that the sale of products that fall under Section 351 of the Public Health Services Act pertaining to marketing traditional biologics and human cells, tissues and cellular and tissue based products (HCT/Ps) can only be sold pursuant to an approved biologics license application (BLA). On July 14, 2019, the Company received Institutional Review Board (IRB) approval to proceed with two pilot studies in connection with the Companys efforts to obtain Investigation New Drug (IND) approval from the FDA and commence clinical trials in connection with the use of the Companys products and related treatment protocols for specific indications. The Company is aggressively pursuing efforts to obtain the aforementioned IND approvals and commence and complete those clinical studies as well as obtaining approval to commence additional studies for other specific indications it has identified that the use of its products will provide more favorable and desired health related benefits for patients seeking alternative treatment options than are currently available.

In an effort to increase sales and mitigate anticipated near future restrictions expected to be imposed by the FDA with respect to the use and distribution of Section 351 designated biologics, the Company is seeking to develop sales and distribution channels outside of the United States. In addition, the Company is focusing its efforts on developing other leading edge product offerings that would not fall within the FDA regulations for requiring a BLA license for U.S. manufacture and sale.

As a result of the Companys expected future increase in processing requirements and to enable it to perform certain advanced research and development activities, the Company is currently in negotiations to relocate its laboratory facility during the second calendar quarter of 2020 to a larger ISO 7 classified research and development and processing facility.

The Company has also been actively developing and expanding its sales, marketing and distribution network which it believes that based on the quality of the Companys existing products, the Companys commitment to regulatory compliance and superior research and development resources, the Company believes that it will be able to achieve desired growth during 2020.

The Company expects to provide periodic updates on operational and financial reporting developments as warranted.

For more information regarding the Company please visit our website at http://www.organicell.com.

About Organicell Regenerative Medicine, Inc.

Organicell is a leading, fully integrated Company focused in the field of regenerative medicine. Our world class research, technology, manufacturing and clinical development team is focused on creating new biologic medicines to revolutionize the field of regenerative medicine. We believe that our ground-breaking research in the field of nanotechnology, specifically exosome enrichments and other micro vesicles, is the next frontier of stem cell-based therapeutics. Organicell is committed to creating life changing and lifesaving therapies for patients.

Our mission is to transform regenerative medicine by continuing to combine exosome technology with other synergistic therapies and become the healthcare technology incubator for biologic medicine.

CAUTIONARY COMMENT REGARDING FORWARD-LOOKING STATEMENTS

The foregoing contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. We intend for these forward-looking statements to be covered by the safe harbor provisions of the federal securities laws relating to forward-looking statements. This release contains forward-looking statements that reflect Organicell Regenerative Medicine Inc., and its subsidiaries, plans and expectations, financial situation, the ability to retain key personnel, product acceptance, the commercial success of any new products or technologies, success of clinical programs, ability to retain key customers, ability to expand sales and channels, and legislation or regulations affecting our operations and the ability to protect our patents and other intellectual property both domestically and internationally and other known and unknown risks and uncertainties. You are cautioned not to rely on these forward-looking statements. In this press release and related comments by Company management, words like "expect," "anticipate," "estimate," "intend", believes and similar expressions are used to identify forward-looking statements, representing management's current judgment and expectations about possible future events.

Management believes these forward-looking statements and the judgments upon which they are based to be reasonable, but they are not guarantees of future performance and involve numerous known and unknown risks, uncertainties and other factors that may cause the Company's actual results, performance, achievements or financial position to be materially different from any expressed or implied by these forward-looking statements. Important factors that could cause actual results to differ materially from the forward-looking statements are set forth in our Form 10-K and other filings with the SEC. Other information can be obtained at http://www.organicell.com. The contents of the Companys website are not incorporated by reference in this Press Release.

Specific information included in this press release may change over time and may or may not be accurate after the date of the release. Organicell has no intention and specifically disclaims any duty to update the information in this press releases.

Organicell Regenerative Medicine Inc.4045 Sheridan Ave.Suite 239Miami Beach, FL 33140Website:http: http://www.organicell.comPhone: (888) 963-7881Email: info@organicell.com

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Organicell Regenerative Medicine Inc. Provides Update On Operations and Financial Reporting Status - GlobeNewswire

Novel mutations in stem cells of young donors can be passed to recipients – BioNews

20 January 2020

A new study suggests that rare harmful mutations in young healthy donors' stem cells can be passed on to recipients of stem cell transplants, potentially leading to health problems.

Stem cell transplants can be used to treat some blood disorders and cancers, such as acute myeloid leukaemia (AML), but can also have life-threatening complications such as cardiovascular problems and graft-versus-host disease (GvHD), where new immune cells from the donor attacks the patient's healthy cells.

'There have been suspicions that genetic errors in donor stem cells may be causing problems in cancer patients, but until now we didn't have a way to identify them because they are so rare,' said Dr Todd EDruley, Associate Professor of Paediatrics, Haematology and Oncology at Washington University School of Medicine, StLouis. 'This study raises concerns that even young, healthy donors' blood stem cells may have harmful mutations and provides strong evidence that we need to explore the potential effects of these mutations further.'Researchers analysed samples from patients with AML and their stem cell donors looking at 80 specific genes. The small pilot study identified at least one harmful genetic mutation in 11 of the 25 donors using an advanced sequencing technique. The donors ranged from 20 to 58 years old, with a median age of 26. Researchers later detected the harmful mutations present in donors within the recipients.

These extremely rare, harmful genetic mutations that are present in donors' stem cells do not cause any health problems to the donors, however, they may be passed on to the patients receiving stem cell transplants. Intense chemo- and radiation therapy is required prior to stem cell transplants and the immunosuppression given after the transplant unfortunately allows the rare mutation containing cells the opportunity to replicate quickly, which potentially can create health problems for the patients who receive them.

Co-author, Dr Sima TBhatt, Assistant Professor of Paediatrics, Haematology and Oncology also at Washington University, said 'Transplant physicians tend to seek younger donors because we assume this will lead to fewer complications. But we now see evidence that even young and healthy donors can have mutations that will have consequences for our patients. We need to understand what those consequences are if we are to find ways to modify them.'

The clinical implications of the findings need to be further studied. Dr Bhatt added: 'Now that we've also linked these mutations to GvHD and cardiovascular problems, we have a larger study planned that we hope will answer some of the questions posed by this one.'

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Gains in Stem Cell Transplant Mortality Over Last 25 Years – MedPage Today

Outcomes have improved over the last quarter-century for patients undergoing allogeneic hematopoietic cell transplantation for treating their cancer, a single-center cohort study indicated.

Reported in the Annals of Internal Medicine, an adjusted analysis revealed that patients who had a transplant from 2013-2017 had a 34% lower risk of dying within 200 days after transplantation from a cause unrelated to disease relapse compared with patients who had a transplant from 2003-2007 (HR 0.66, 95% CI 0.48-0.89).

These patients from the later era also had an adjusted lower risk of disease relapse (HR 0.76, 95% CI 0.61-0.94), dying from relapse (HR 0.69, 95% CI 0.54-0.87), and dying from any cause (HR 0.66, 95% CI 0.56-0.78), according to George McDonald, MD, of Fred Hutchinson Cancer Research Center in Seattle, and colleagues.

The improvement in overall mortality was seen regardless of whether patients had myeloablative conditioning therapy versus reduced-intensity conditioning therapy or whether the transplant was from a matched sibling or unrelated donor.

"This is good news," Ryotaro Nakamura, MD, co-director of the Center for Stem Cell Transplantation at City of Hope in Duarte, California, told MedPage Today. Nakamura, who was not involved in the research, said the study shows at least "some progress" but the outcomes are still "far from perfect."

The results of the cohort study are based on data from 1,148 patients who had their first transplant from 2003-2007 and 1,131 patients who had their first transplant from 2013-2017, all of whom were treated at Seattle Cancer Care Alliance. Most patients had acute lymphocytic leukemia, acute myeloid leukemia, or myelodysplastic syndrome.

Although the results are from a single institution, Nakamura believes they are "largely applicable to the field in general."

These latest data show a trend in improved outcomes over not just the past 10 years, but 25. Previously, the study researchers showed in a 2010 study that 30% of patients who had a transplant from 1993-1997 died within 200 days after transplantation. The incidence has declined to 16% for patients from the 2003-2007 era and 11% for patients from the 2013-2017 era.

In addition, rate of relapse and overall mortality also improved over the three time periods, but the greatest improvement was seen for the rate of non-relapse mortality within 200 days. Relapse-related mortality was not assessed in the previous study for the 1993-1997 era.

Although the current cohort study cannot identify what caused the improvement in outcomes, "we can speculate about what changes in our transplant practices have contributed to better outcomes," McDonald told MedPage Today.

For starters, the risk of infection through 100 days after transplant was lower for patients treated from 2013-2017 compared with 2003-2007. These later-era patients had a lower risk of invasive mold infection (HR 0.55, 95% CI 0.33-0.92) and gram-negative bacteremia (HR 0.42, 95% CI 0.29-0.60).

Also, while the risk of any cytomegalovirus (CMV) infection did not decrease for later-era patients (HR 1.15, 95% CI 0.88-1.52), the risk of having a higher CMV viremia did. Specifically, the risk of CMV infection of more than 250 IU/mL (HR 0.78, 95% CI 0.55-1.10) or more than 1,000 IU/mL (HR 0.46, 95% CI 0.28-0.74) declined.

McDonald said that the lower frequency of serious infection may be due to the emergence of molecular methods of diagnosis and newer treatments. Also, the practice of treating graft-vs-host disease (GVHD) has changed.

Patients from the 2013-2017 era received lower initial doses of prednisone on average to treat GVHD (mean 0.58 vs 0.83 mg/kg, P<0.001) as well as had a lower total prednisone exposure (mean 0.08 vs 0.05, P<0.001). These reductions in prednisone allowed patients to avoid "many" of the side effects of prednisone, including loss of muscle mass, diabetes, and hypertension, explained McDonald.

In addition, the odds of a grade 3/4 GVHD event was lower among later-era patients compared with earlier-era patients (OR 0.63, 95% CI 0.46-0.86), as was the odds of chronic GVHD (OR 0.40, 95% CI 0.33-0.48).

Patients from the 2013-2017 period also had less frequent acute kidney injury, respiratory failure, and liver dysfunction during the first 100 days after transplant.

"The gradual shift from very high-dose conditioning therapy to less intense myeloablative therapy and to reduced-intensity conditioning was likely responsible for a reduction in damage to the liver, lungs, and kidneys over the last 10 years," McDonald said.

The study was primarily funded by the National Institutes of Health. Other funding sources included a grant from the American Cancer Society and individual awards. One study researcher was supported by a contract from the Patient-Centered Outcomes Research Institute. The funding sources did not influence the reporting of the study data.

Several study authors, including McDonald, reported having industry relationships.

Nakamura reported having no relevant conflicts of interest.

2020-01-20T17:00:00-0500

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Gains in Stem Cell Transplant Mortality Over Last 25 Years - MedPage Today

Biomedical Applications of Zeolitic Nanoparticles, with an Emphasis on | IJN – Dove Medical Press

Hossein Derakhshankhah, 1, 2,* Samira Jafari, 1, 2,* Sajad Sarvari, 3 Ebrahim Barzegari, 4 Faezeh Moakedi, 5 Milad Ghorbani, 6 Behrang Shiri Varnamkhasti, 1 Mehdi Jaymand, 7 Zhila Izadi, 1, 8 Lobat Tayebi 9

1Pharmaceutical Sciences Research Center, Health Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; 2Zistmavad Pharmed Co., Tehran, Iran; 3Department of Pharmaceutical and Pharmacological Science, School of Medicine, West Virginia University, Morgantown, WV, USA; 4Medical Biology Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; 5Department of Biochemistry and Molecular Biology, School of Medicine, West Virginia University, Morgantown, WV, USA; 6Department of Chemical Engineering, College of Engineering, University of Tehran, Tehran, Iran; 7Nano Drug Delivery Research Center, Health Technology Institute, Kermanshah University of Medical Sciences, Kermanshah, Iran; 8Department of Regenerative Medicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology, ACECR, Tehran, Iran; 9Marquette University School of Dentistry, Milwaukee, WI 53201, USA

*These authors contributed equally to this work

Correspondence: Zhila Izadi; Lobat Tayebi Email izadi_zh@razi.tums.ac.ir; lobat.tayebi@marquette.edu

Abstract: The advent of porous materials, in particular zeolitic nanoparticles, has opened up unprecedented putative research avenues in nanomedicine. Zeolites with intracrystal mesopores are low framework density aluminosilicates possessing a regular porous structure along with intricate channels. Their unique physiochemical as well as physiological parameters necessitate a comprehensive overview on their classifications, fabrication platforms, cellular/macromolecular interactions, and eventually their prospective biomedical applications through illustrating the challenges and opportunities in different integrative medical and pharmaceutical fields. More particularly, an update on recent advances in zeolite-accommodated drug delivery and the prevalent challenges regarding these molecular sieves is to be presented. In conclusion, strategies to accelerate the translation of these porous materials from bench to bedside along with common overlooked physiological and pharmacological factors of zeolite nanoparticles are discussed and debated. Furthermore, for zeolite nanoparticles, it is a matter of crucial importance, in terms of biosafety and nanotoxicology, to appreciate the zeolite-bio interface once the zeolite nanoparticles are exposed to the bio-macromolecules in biological media. We specifically shed light on interactions of zeolite nanoparticles with fibrinogen and amyloid beta which had been comprehensively investigated in our recent reports. Given the significance of zeolite nanoparticles interactions with serum or interstitial proteins conferring them new biological identity, the preliminary approaches for deeper understanding of administration, distribution, metabolism and excretion of zeolite nanoparticles are elucidated.

Keywords: zeolite, mesoporous, nanostructure, biosafety, biomedical applications

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Biomedical Applications of Zeolitic Nanoparticles, with an Emphasis on | IJN - Dove Medical Press