Category Archives: Regenerative Medicine

Biotech startup aims to unlock hair regrowth, skin rejuvenation, disease treatment by preserving cells.

Toronto-based biotechnology startup Acorn Biolabs, which helps customers freeze their stem cells in preparation for cell-based regenerative medicine treatments, has announced approximately $11 million CAD ($8 million USD) in Series A funding across multiple closings.

The all-equity, all-primary round was led by new backer Merz Aesthetics with support from Telus Global Ventures, MDE Investments, The Leslie Group, Lee Li Holdings, and several undisclosed physicians in the aesthetics, orthopedic, and longevity fields.

Acorn claims to offer the worlds first non-invasive, [hair] follicle-based cell cryopreservation service.

Founded in 2017, Acorn aims to provide clients with access to personalized regenerative medicine through what it claims is the worlds first non-invasive, [hair] follicle-based cell cryopreservation service and patented cell-based treatments from patients hair follicle cells. By preserving cells, the startup hopes to unlock the possibility of future hair regrowth, skin rejuvenation, injury recovery, and disease treatment through regenerative medicine.

Acorn plans to use this capital to expand its commercial footprint and develop cosmetic offerings. Acorn co-founder and CEO Drew Taylor told BetaKit he believes that since its launch in North America over a year ago, Acorn has proven its model in hair follicle-based stem cell banking. He expects the startups business to accelerate following investments in direct-to-consumer advertising and in-clinic promotion.

We are entering a pivotal time in our history where well launch the first, personalized cosmetic skin and hair product made specially leveraging the persons own hair follicles, said Taylor. We believe the market is primed for this type of personalized approach based on the positive reception weve received to date.

Taylor declined to share when the startups Series A round closed. He also declined to share the companys valuation but claimed it was higher than Acorns seed financing. With this latest capital, Acorn has now raised more than $13.6 million CAD in total funding to date.

The announcement of Acorns Series A round comes more than five years after Acorn raised $3.3 million in seed funding from Real Ventures, Globalive Technology, Pool Global Partners, and Epic Capital Management to fuel its launch. In 2021, Acorn closed another $250,000 from MCI OneHealth, now Healwell AI.

RELATED: Fuelled by Well Health partnership, Healwell looks to apply AI to preventative care

Last year, Acorn launched its stem cell banking service in Canada and the United States.

Acorn customers can visit participating clinicsoften dermatologists or plastic surgeonsand have a clinician collect a sample of their hair follicles, which Acorn then preserves at their labs indefinitely until they are required again. Clients pay an annual subscription fee for this service. In 2023, Taylor said Acorn saw cumulative patient growth of more than 10 percent monthly.

Taylor claimed that Acorn and its 21-person team possess a true first-movers advantage in the category of stem cell cryopreservation leveraging hair follicles as the source.The next step in the companys evolution involves creating topical skin and hair care products, which Acorn plans to make available through those same clinics.

Taylor said Acorn will also expand its commercial operation partner sites in North America and hire a sales team to support clinics in dermatology and plastic surgery, as it gears up to launch its first skin and hair care product in the next year.

RELATED: Biotech startup Noa Therapeutics raises $2.2 million in pre-seed funding

He acknowledged that the skin and hair care markets are both quite large and competitive, but claimed that no other company currently sells a personalized skin or hair care product like the one Acorn plans to launch. Taylor noted that other offerings in the topical cosmetic space leverage donated tissues from other humans or derived from plants.

In a statement, Merz Aesthetics chief corporate development officer Jon Parrish noted that regenerative aesthetics aims to stimulate the bodys own systems to repair and restore the structure and integrity of aging skin.

We are looking to invest in opportunities that lie at the intersection of regenerative aesthetics and personalized medicine and our investment in Acorn directly aligns with this strategy, he added.

Feature image courtesy Acorn Biolabs.

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Acorn Biolabs nabs $11M Series A to boost access to regenerative medicine via cell preservation - BetaKit - Canadian Startup News

Award Will Support the First U.S. Multi-center, Multi-patient Phase 1/2a Trial of an Autologous Neurological Therapy

SAN DIEGO, May 15, 2024 /PRNewswire/ --Aspen Neuroscience, Inc., a California-based private biotechnology company developing personalized regenerative therapies, has received a CLIN2 grant award of $8 million from the California Institute for Regenerative Medicine (CIRM), the world's largest institution dedicated to regenerative medicine, to support clinical research aimed at treating Parkinson's disease (PD).

The grant, a first for an autologous therapeutic for degenerative neurological conditions, will help advance the development of ANPD001, an investigational iPSC-derived dopaminergic neuron replacement therapy.

Award will support the first U.S. multi-center, multi-patient Phase 1/2a trial of an autologous neurological therapy

ANPD001 is being studied in a First in Human Phase 1/2a clinical trial for patients with moderate to advanced PD, to assess safety and tolerability. This is the first use of the autologous approach in a multi-patient and multi-center clinical trial.

"This clinical award represents a significant step forward in the treatment landscape of Parkinson's disease by advancing individualized therapy, which has the potential to restore motor function in patients impacted by this devastating condition," said Dr. Abla Creasey, PhD, Vice President of Therapeutics Development at CIRM.

"We are honored to receive support from CIRM, an incredible sponsor of innovation. ANPD001 was developed in California, and is now being produced and studied here," said Damien McDevitt, PhD, President and CEO of Aspen Neuroscience, Inc. "Providing patients in this study with dopamine neurons made from their own cells is a huge leap forward for personalized medicine, and has the potential to impact the entire field of neurodegenerative disorders."

Affecting more than one million Americans, PD is a neurodegenerative disorder that causes walking and motor problems, as well as impaired balance and coordination. Existing therapies alleviate symptoms but do not treat the underlying disease process, leading to a significant unmet medical need for those suffering from this chronic condition.

"Parkinson's disease is the most common neurodegenerative movement disorder, primarily by depleting dopamine neurons in the midbrain. By the time of diagnosis, it is common for people with Parkinson's to have lost the majority of dopaminergic (DA) neurons, leading to progressive loss of motor and neurological function," explained Edward Wirth III, MD, PhD, Chief Medical Officer of Aspen Neuroscience. "Our Phase 1/2a study has completed enrollment, the first patient has been dosed and we will continue dosing patients this year."

About the California Institute for Regenerative Medicine (CIRM)At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and act with a sense of urgency to succeed in that mission.

To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today's most promising stem cell technologies.

With $5.5 billion in funding and more than 150 active stem cell programs in our portfolio, CIRM is one of the world's largest institutions dedicated to helping people by bringing the future of cellular medicine closer to reality. For more information go to http://www.cirm.ca.gov

About the ASPIRO TrialASPIRO is an open-label Phase 1/2a clinical trial to assess the safety and tolerability of ANPD001 in patients with moderate to severe Parkinson's disease.The trial includes patients 5070 years of age, and excludes patients with cognitive impairment and other comorbidities that could preclude treatment. All enrolled patients are under the care of a movement disorder specialist.

The primary study endpoint is safety and tolerability of two sequential escalating doses of ANPD001. Secondary endpoints include improvement in "on" time, when patients experience periods of good symptom control, and improvements in motor symptoms and quality of life based on standard Parkinson's disease rating scales.

About Aspen Neuroscience Headquartered inSan Diego, Aspen Neuroscience, Inc. is a clinical development-stage, private company focused on autologous regenerative medicine. The company's patient-derived iPSC platform is used to create personalized therapies to address diseases with high unmet medical needs, beginning with autologous neuron replacement for Parkinson's disease.

Aspencombines cell biology with the latest machine learning and genomic approaches to investigate patient-specific, restorative cell treatments. The company has developed a best-in-class platform to create and optimize pluripotent-derived cell therapies, which includes in-house bioinformatics, manufacturing and quality control. For more information and important updates, please visithttps://www.aspenneuroscience.com.

SOURCE Aspen Neuroscience, Inc.

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Aspen Neuroscience Receives CLIN2 Grant for ANPD001 from California Institute for Regenerative Medicine (CIRM) - PR Newswire

In April, the Training Undergraduates in Stem Cell Engineering and Biology (TUSCEB) program marked a significant milestone toward its mission of fostering excellence in stem cell engineering and biology education by hosting its first symposium.

As the cornerstone of our TUSCEB program, this symposium highlighted the specialized stem cell training and biological research activities of our trainees, said program Co-Director Professor Kara McCloskey.

TUSCEB is a collaborative effort between UC Merceds School of Natural Sciences and School of Engineering.

The programs first cohort of scholars showcased their research projects through engaging poster presentations. This platform served as a demonstration of their hard work and dedication and facilitated meaningful interactions with peers, faculty members, industry professionals and community members.

The symposium also offered a comprehensive educational experience through a series of foundational talks from an insightful exploration into the world of stem cells to a detailed overview of the TUSCEB program by McCloskey and Co-Director Professor Jennifer Manilay.

Attendees were enriched with knowledge crucial for navigating the complex landscape of stem cell engineering and biology. The highlight of the event was a talk on medical ethics by guest speaker philosophy Professor Hanna Gunn, whose expertise shed light on ethical considerations in the pursuit of groundbreaking scientific endeavors.

Our TUSCEB Symposium was not only a showcase of academic achievements, but a testament to our unwavering dedication toward shaping the next generation of leaders in regenerative medicine, Manilay said.

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Stem Cell Engineering and Biology Program Hosts First Symposium | Newsroom - University of California, Merced

Back in 2022, the news that a team of scientists had used a multi-drug cocktail to stimulate the regeneration of a frogs leg made headlines around the world. The story was remarkable, first because the animal in question, the African clawed frog, doesnt naturally regenerate complex limbs in adulthood, and second because the drugs were used to establish specific bioelectrical states that stimulated regeneration of the limb.

The scientists behind that research, Tufts University professors Michael Levin and David Kaplan, co-founded a company called Morphoceuticals to explore the potential of their work in regenerative medicine. When we first spoke with Levin, he told us of the companys intention to build a turnkey regenerative medicine platform that would allow the potential of bioelectrical signaling to be harnessed to enable limb and organ regeneration in humans.

Backed by Juvenescence and Prime Movers Lab, Morphoceuticals recently appointed biotech veteran Dr Jim Jenson to the role of CEO, as it seeks to build the first map of the druggable bioelectrome the electrical network in our bodies that ultimately controls tissue repair and regeneration.

Longevity.Technology: In contrast to the electrons that power the electrical networks in our homes, our bioelectrome is powered by ions, which can be manipulated by so-called ion channel drugs to establish different bioelectrical states, including those that promote regeneration. Of course, before you can start drugging anything, you need to know what signals are required to activate a desired response hence the need for a map. We caught up with Jenson to find out more about Morphoceuticals immediate objectives and the path towards human applications of its technology.

On its web site, Morphoceuticals describes the bioelectrome as a form of non-neural, multi-cellular cognition which tells cells what tissues to build and, crucially, when to stop. Jenson says the regenerative potential of the bioelectrome is what attracted him to the company.

Ive been in this business for 35 years now, but what is what is unique about Morphoceuticals is the extraordinary opportunity to develop a higher level omics above proteomics and genomics and transcriptomics with such potential for unlocking real control of tissue repair, an organ regeneration, he says.

Of course, Morphoceuticals didnt discover the bioelectrome. Indeed, Jenson says its existence has been known for over a hundred years.

In the last few decades, weve developed our understanding of what leads to this circuitry the ion channels, that every cell is a little battery in every living thing that makes currents, and that cells work collectively to control shape and form, he says. Its just an extraordinary area that is yet untapped by pharma, to a significant degree. But it can be tapped.

Jensons confidence stems from the fact that the tools already exist to allow the bioelectrome to be quantified.

The tools for measuring bioelectricity exist, both the currents and the specific voltage states on a cellular basis, he says. And then the multi-omics tools exist at a very sophisticated level for measuring in each condition, which voltage channels are prominent. Finally, now the artificial intelligence capability also exists to allow us to analyze the vast amounts of data that will be generated.

Mapping the bioelectrome sounds like an undertaking similar to that of the Human Genome Project, or the more recent Human Immunome Project, but Jenson says Morphoceuticals task should be in some ways easier than those initiatives.

There are only 400 ion channels that need to be opened or closed its a finite number, much smaller than the genome, he says. And the tools are there to measure it, so we dont have to create the tools as we did in the genome project. And there are far fewer moving parts in the bioelectrome than in the immunome, for example, so I think its a more approachable task to map it, and I think it will emerge within a shorter timeframe than the other omics.

To begin with, Jenson explains that Morphoceuticals will collect the relevant electrophysiological data, along with the corresponding multi-omics and cellular data, for resting states versus regenerating states, and for disease states versus healthy states in tissues.

After weve collected all that data, well need artificial intelligence to tell us the signatures associated with healthy and regenerating states, he says. And then, as those signatures are identified, well be able to use AI again to identify the triggers that we can pull for tissue growth and regeneration.

To date, Morphoceuticals has existed in essentially virtual form, supporting the ongoing work in its co-founders labs at Tufts. One of Jensons first objectives is to turn the company into an operational entity.

Over the next year or two were going to build out the team, the first elements of which are already in place, and build the toolkit that can help us generate the first map of a druggable bioelectrome, he says.

In terms of which therapeutic areas Morphoceuticals will target with its technology, Jenson indicates its too early to say.

Were going to let the science lead us, he says. The stump health work that we started in the frogs is still underway, but our emphasis now is primarily on building a much broader picture of the signatures. The science will tell us where to focus what is most tractable and for what are there good translational models the usual drug discovery components.

This will provide the path to triggers for tissue growth and regeneration for maladies that are addressable, with translational models, and we will have products going toward the clinic. Perhaps even more importantly, we will have cracked open the bioelectrome as a way of introducing new therapeutic modalities, opening up a new field of bioelectromics on which other companies will build.

Originally posted here:
Could mapping the bioelectrome lead to limb and organ regeneration drugs? - Longevity.Technology

Coming under the area of regenerative medicine, orthobiologics is a rapidly advancing field that offers new options to treat acute orthopedic injuries and chronic or degenerative conditions without surgery. These products contain growth factors to relieve pain, stimulate tissue healing, and reinstate normal function. There are many types of orthobiologic, and each one has a unique mode of action. As they are one of multiple promising treatments for muscle, joint, and soft tissue injuries, there are now many companies operating within this field.

In this article, we take a look at five orthobiologics companies leading the way in this area.

Bioventus works to deliver cost-effective products that help people heal quickly and safely. The innovations for active healing from the company include offerings for pain treatments, restorative therapies and surgical solutions. In fact, the companys surgical unit says it is specifically driven to advance the science and surgical performance of orthobiologics with a comprehensive portfolio of clinically efficacious and cost-effective solutions.

Bioventus portfolio of surgical biologics offers a wide variety of bone graft solutions to meet the needs of surgeons and their patients, across a broad range of patient needs, procedures, and costs. The products include different types of allografts, an autologous cell and bone marrow extractor (to add needed cells and signals to aid in bone healing), and a suite of minimally invasive therapeutic ultrasonic technologies based on its neXus Ultrasonic Surgical Aspirator System, which is optimized for hard and soft tissue removal.

Isto Biologics is a biologics and cellular therapy company in the orthopedic space. Its focus is on finding ways to help heal patients faster through innovative solutions for bone regeneration and cell-based therapies. The companys flagship product offerings include the Magellan autologous concentration system, which delivers concentrated platelets and cells at the point of care, and bone-growth products, including InQu Bone Graft Extender & Substitute and the Influx product family.

In October 2023, Isto merged with Advanced Biologics, a California-based company known for its biologic solutions. The merger was intended to integrate Advanced Biologics proprietary products into Istos portfolio of allografts found within its Influx line. Prior to the merger, the two companies had maintained a commercial partnership since 2020, catalyzed by the development of Istos Integrative Bone Matrix, SPARC, which is a novel inductive bone matrix that stemmed from Advanced Biologics proprietary tissue processing method used in its allograft, OsseoGen.

Locate Bio, a company committed to developing next-generation orthobiologics, has LDGraft as its main product in development. It is intended for anterior lumbar interbody spinal fusion (ALIF) procedures for patients with degenerative disc disease, an irreversible and debilitating disease that has a significant impact on day-to-day functioning. LDGraft has been designed to provide both an osteoconductive scaffold and a controlled and extended release of osteoinductive recombinant human bone morphogenetic protein 2 (rhBMP-2).

In May last year, Locate Bios LDGraft was granted breakthrough device designation by the U.S. Food and Drug Administration (FDA), which is intended to accelerate patient access to promising technologies that have the potential to provide more effective treatment or diagnosis for life-threatening or irreversibly debilitating diseases or conditions. Furthermore, just last month, the orthobiologics company also managed to raise 9.2 million ($11.6 million) in a funding round from new and existing investors. The proceeds from this will be used to fund a clinical study of LDGraft.

A spin-off of the Swiss Federal Institute of Technology, Kuros Biosciences is viewed as a leader in next-generation bone graft technologies, and it has locations in the U.S., Switzerland, and the Netherlands. The companys first commercial product is called MagnetOs, which is an advanced bone graft that, according to the company, has already been used across three continents in 25,000 fusion surgeries. MagnetOs NeedleGrip surface technology means that it grows bone even in soft tissues. This surface technology provides traction for the bodys vitally important pro-healing immune cells (M2 macrophages). This, in turn, unlocks previously untapped potential to stimulate stem cells and form new bone throughout the graft.

In January 2024, Kuros received an FDA 510K clearance for MagnetOs Granules for interbody use, as well as regulatory clearance for MagnetOs Granules and MagnetOs Putty in New Zealand. Earlier in January, Kuros also announced the FDA clearance of MagnetOs Easypack Putty for interbody use and MagnetOs Putty for standalone use in the posterolateral spine, meaning it can now be used without the need for autograft.

Orthobiologics company OssDsign is focused on developing and marketing products that support the bodys own healing capabilities. The companys primary product is the OssDsign Catalyst, which is a nanosynthetic bone graft putty designed to engage dual bone formation pathways resulting in rapid and reliable bone formation at early time points throughout the entire fusion mass. It has recently been indicated for use in interbody cages in spinal surgery and is the first synthetic bone graft to be cleared to market for interbody use based on bone graft data alone.

At the beginning of last month, OssDsign announced that it has been awarded a new group purchasing agreement for Bone and Bone Substitute Implantable Products with Premier, a leading U.S. healthcare improvement company uniting an alliance of approximately 4,350 U.S. hospitals and health systems and more than 300,000 other providers and organizations. Effective in July, this agreement allows Premier members to take advantage of special pricing and terms pre-negotiated by Premier for the OssDsign Catalyst.

Ongoing advancements in biotechnology and regenerative medicine have contributed to the development of innovative orthobiologics products, with novel biomaterials, growth factors, stem cell therapies, and tissue engineering techniques expanding treatment options and driving market growth. According to a recent report by Market.us, the global orthobiologics market size is expected to be worth around $14.2 billion by 2033 from $7.9 billion in 2023, growing at a compound annual growth rate (CAGR) of 6% during the forecast period from 2024 to 2033.

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Five orthobiologics companies leading the way in the field - Labiotech.eu

Funding routes

We are keen to support high quality research into stem cells and regenerative medicine that:

Advanced therapeutics (including cell and gene therapy, regenerative medicine and innovative medicines) is one of three MRC-wide opportunity areas that apply to all boards and panels, used to help prioritise applications for funding.

Our four research boards fund science that enhances our knowledge of the biology of health and disease and new approaches to treatment, including fundamental or investigative research, for example hypothesis-led research seeking to:

The choice of which board to submit to will depend upon the nature of the work and the disease being investigated. Basic stem or progenitor cell research of a more generic nature should be directed to the Molecular and Cellular Medicine Board. Regenerative medicine research that moves beyond underpinning biological mechanisms and focuses on particular organs or tissues and associated dysfunction or disease, other than haematology, are more likely to align with one of the other research boards:

The Developmental Pathway Funding Scheme is a key part of our Translational Research Strategy and supports the translation of fundamental discoveries toward benefits to human health. It funds the pre-clinical development and early clinical testing of novel therapeutics, devices and diagnostics, including repurposing existing therapies.

Regenerative medicine research projects are eligible for all our training investments. More information about training grants is available, specifically for fellowships and studentships.

The Steering Committee for the UK Stem Cell Bank and use of Stem Cell Lines publishes the UK stem cell line registry, which identifies all human embryonic stem cell lines approved for use in the UK. We will not support research using human embryonic stem cell lines that the steering committee has not approved.

Read the UK stem cell line registry.

The UK Stem Cell Bank provides ethically-sourced and quality controlled human embryonic stem cell (hESC) lines and other associated materials to researchers worldwide, and aims to facilitate high quality and standardised research in this area. The bank publishes a catalogue of currently available hESC lines.

The Human Induced Pluripotent Stem Cell Initiative (HipSci) generated a large, high-quality reference panel of genotypically and phenotypically characterised human induced pluripotent stem cells (iPSC). HipSci cell lines are available through the European Collection of Authenticated Cell Cultures (ECACC)

MRC has issued guiding principles on expectations regarding requests for support for establishing new iPSC resources.

The International Stem Cell Banking Initiative (ISCBI) provides information for scientists interested in developing or using a stem cell bank. The initiatives aim is to create a global network of stem cell banks through support for existing banks, and by encouraging the development of new banks.

The ISCBI encourages good practice in stem cell banking scientifically and ethically and provides information on resources and meetings for those involved in stem cell banking.

The MRC-Wellcome Trust human developmental biology resource is a collection of human embryonic and foetal material available for the international scientific community to research.

The NHS Blood and Transplant special health authority includes:

The Innovate UK-funded Cell and Gene Therapy Catapult is an independent centre of excellence, designed to advance the growth of the UK cell and gene therapy industry by bridging the gap between scientific research and full-scale commercialisation. It works with partners in academia and industry to ensure that life-changing therapies can be developed for use in health services throughout the world.

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Regenerative medicine UKRI - UK Research and Innovation

For many centuries, we have looked to medicine to heal us when we are sick or injured. Major breakthroughs, like vaccines and antibiotics, have improved quality of life, and, in some cases, led to the effective eradication of infectious diseases.

While modern medicine has certainly changed the human experience for the better, we remain at the mercy of disease. There are no vaccines for malaria or HIV, for example. And chronic diseases, like heart disease, Alzheimers, diabetes, and osteoporosis, although treatable, are relentless causes of suffering. There are no silver bullet for these conditions. Often the best we can do is manage the symptoms.

One key to changing that may be regenerative medicine, a field of research with its sights set on the root causes of diseases, including many being studied now at the Institute for Stem Cell and Regenerative Medicine (ISCRM).

As a discipline, regenerative medicine combines principles of biology and engineering to develop therapies for diseases characterized by cell depletion, lost tissue, or damaged organs. The broad aim of regenerative medicine is to engineer, regenerate, or replace tissue using natural growth and repair mechanisms, such as stem cells. Organoids, 3D organ printing, and tissue engineering are examples of biopowered technologies used in regenerative medicine.

Many common chronic diseases begin with harmful cell depletion. For example, Alzheimers disease is associated with a loss of brain cells, heart disease is often marked by a loss of healthy heart muscle, and type 1 diabetes occurs when cells in the pancreas fail to produce insulin. In the case of cancer, the problem is that cells grow too quickly. (Click here to read more about diseases being researched at ISCRM.)

For scientists, regenerative medicine is a way to fix the root causes of disease by harnessing the bodys natural capacity to repair itself in other words, to regenerate lost cells and tissue and restore normal functioning. At the Institute for Stem Cell and Regenerative Medicine, researchers are studying how to jump start the growth of cells in the brain, heart, pancreas, liver, kidney, eyes, ears, and muscles.

Ultimately, the goal of regenerative medicine is to improve the daily wellbeing of patients with debilitating chronic diseases by developing a new generation of therapies that go beyond treating symptoms.

Stem cells are powerful tools of discovery used by researchers hoping to understand how regenerative medicine could be used to treat patients. Right now, ISCRM researchers are using stem cells to study how heart diseases develop, testing stem cell-based therapies that could regenerate damaged or lost heart tissue, and even launching heart tissue into space to study the effects of microgravity on cardiovascular health. Many ISCRM scientists use stem cells to create 3D organ models, known as organoids, that allow them to study diseases and test regenerative treatments without involving animals or human subjects.

Heart Regeneration Researchers in multiple ISCRM labs are pursuing novel approaches that can potentially cure rather than manage heart disease. In 2018, a study led by ISCRM Director Dr. Charles Murry demonstrated that stem cell-derived cardiomyocytes have the potential to regenerate heart tissue in large non-human primates, a major step toward human clinical trials. In another investigation, ISCRM faculty members Jen Davis, PhD and Farid Moussavi-Harami, MD are developing new tools to help cardiologists design personalized treatments for certain heart diseases.

Diabetes ISCRM researchers are studying the mechanisms that regulate the development and function of beta cells in the pancreas that produce insulin a key to future treatments for any type of diabetes. Vincenzo Cirulli MD, PhD, is screening for biological factors that could promote the growth of beta cells necessary for insulin production. Dr. Cirullis ISCRM colleague Laura Crisa MD, PhD is using a disease-in-a-dish model to study how islet cells falter and whether they can be regenerated, and eventually transplanted, into patients.

Vision Disorders Researchers at the Institute for Stem Cell and Regenerative Medicine (ISCRM) are using stem cell-derived retinal organoids to study how diseases of the retina form and how they can be treated. Organoids closely approximate human tissue without many of the ethical questions and supply limitations that complicate the use of fetal tissue. Read more about recent efforts to validate stem cell-derived organoids as disease models here.

In an approach could someday be used to help repair the retinas in patients who have lost vision due to macular degeneration, glaucoma and diabetes, the Reh Lab has successfully induced non-neuronal cells to become retinal neurons. In an October 2021 study published in the journal Cell Reports, Reh and his team using proteins (known as transcription factors) that regulate the activity of genes to induce glial cells in the retina to produce neurons. The effort demonstrates that gene therapy could someday be used in clinics to help repair damaged retinas and restore vision.

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What Is Regenerative Medicine? | Goals and Applications | ISCRM

Prolotherapy injections

Sports medicine specialists use prolotherapy injections to address connective tissue injuries. Research on prolotherapy highlights its potential to reduce pain from early to moderate osteoarthritis, sacroiliac (SI) joint ligaments, and tendinopathy.

Prolotherapy injects a solution made of specific concentrations of dextrose (sugar water), saline (salt and water), and a numbing medication into damaged tissue. Studies have shown the dextrose concentrate itself can stimulate the release of growth factors, explains Dr. Borg Stein. It can also cause some temporary inflammation in the area, which is intended to help kickstart a healing process that may have stalled."

Like all injection therapies, prolotherapy uses a special needling technique during the injection with the goal of increasing your bodys healing response.

Both prolotherapy and extracorporeal shockwave therapy are attractive treatment options when taking time off isnt in the playbook. We often do these treatments with athletes who are in season, sometimes in combination with each other, says Dr. Borg Stein. In most cases, theres really little to no downtime.

Originally posted here:
What Is Regenerative Medicine? | Mass General Brigham

By: Peter Marks, M.D., Ph.D., Director, Center for Biologics Evaluation and Research

The U.S. Food and Drug Administration plays a vital role in facilitating the development and availability of innovative medical products. Products such as cellular-derived therapies, including stem cell-based products, offer the potential to treat or even cure diseases or conditions for which few effective treatment options exist.

The FDAs November 2017 regenerative medicine policy framework was developed to help facilitate and support innovation in the area of regenerative medicine therapies. As part of this framework, we encourage sponsors to take advantage of ongoing expedited programs that might be available to them, including Regenerative Medicine Advanced Therapy, breakthrough therapy, and fast track designations, to support product development and licensure.

The framework also outlines the agencys intent to exercise enforcement discretion with respect to the FDAs investigational new drug (IND) and premarket approval requirements for certain regenerative medicine products until November 2020, which was later extended through May 2021. This compliance and enforcement discretion policy gives manufacturers time to determine if certain requirements apply to their products, and if an application is needed, to prepare and submit the appropriate application to the FDA.

We are now reaffirming the timing of the end of the compliance and enforcement discretion policy for certain human cell, tissue, and cellular and tissue-based products (HCT/Ps), including regenerative medicine therapies. The period during which the FDA intends to exercise enforcement discretion with respect to the IND and premarket approval requirements for certain HCT/Ps ends on May 31, 2021, and will not be extended further.

Since November 2017, the FDA has worked with product developers to help them determine if they need to submit an IND or marketing application and, if so, how they should submit their application to the FDA. The FDA developed programs that provide opportunities for engagement between HCT/P manufacturers and the agency, including the Tissue Reference Group (TRG) Rapid Inquiry Program (TRIP). TRIP helped manufacturers of HCT/Ps, including stakeholders that market HCT/Ps to physicians or patients, obtain a rapid, preliminary, informal, non-binding assessment from the FDA regarding how specific HCT/Ps are regulated. TRIP was a temporary program of the TRG. The TRIP began in June 2019 and was extended twice. It recently ended on March 31, 2021.

Despite all of the FDAs efforts to engage industry, there continues to be broad marketing of these unapproved products for the treatment or cure of a wide range of diseases or medical conditions. Many of these unapproved products appear to be HCT/Ps that are regulated as drugs, devices and/or biological products subject to premarket approval requirements. The wide extent of the marketing of such unapproved products is evidenced by their inappropriate advertisement in various media and by the number of consumer complaints about them submitted to the FDA.

These regenerative medicine products are not without risk and are often marketed by clinics as being safe and effective for the treatment of a wide range of diseases or conditions, even though they havent been adequately studied in clinical trials. Weve said previously and want to reiterate here there is no room for manufacturers, clinics, or health care practitioners to place patients at risk through products that violate the law, including by not having an IND in effect or an approved biologics license. We will continue to take action regarding unlawfully marketed products. Our oversight of cellular and related products has included taking compliance actions, including numerous warning and untitled letters, and pursuing enforcement action for serious violations of the law.

Since December 2019, the agency has issued more than 350 letters to manufacturers, clinics, and health care providers, noting that it has come to our attention that they may be offering unapproved regenerative medicine products and reiterating the FDAs compliance and enforcement policy.

We encourage the public and patients who are considering treatment with regenerative medicine products to work with their health care providers to learn about the treatment being offered. Ask questions and understand the potential risks of treatment with unapproved products. It is critical to only seek treatment using legally marketed products, or, for unapproved products, to enroll in clinical trials under FDA oversight. The public can visit the FDAs website to find out if a particular regenerative medicine product is approved.

The FDA remains committed to helping advance the development of safe and effective regenerative medicine products, including stem cell-based products, to benefit individuals in need. We look forward to working with those who share this goal.

Originally posted here:
Advancing Safe and Effective Regenerative Medicine Products

Learn More about Organicell Regenerative Medicine, Inc. by gaining access to the latest research report

In the medical community, the popularity of regenerative medicine is reportedly soaring primarily because research around these therapies shows promise in treating a wide range of musculoskeletal pain conditions.

Armed with the belief that the human body can heal itself, regenerative medicine treatments like exosome therapy and stem cell therapy are advancing.

But regenerative medicine has sometimes been embroiled in controversy beginning in 1981 when scientistsdiscoveredways to derive embryonic stem cells from early mouse embryos.

That discovery was followed by a method to derive stem cells from human embryos and grow the cells in the laboratory in 1998.

Massive players likeAmgen Inc.AMGN,Sanofi SASNY, andGilead Sciences Inc.GILD have advanced stem cell research and therapies.

Unlike stem cell therapy, Organicells OCEL exosome therapy doesn'tinvolveusing donor cells or umbilical cords. Instead, the exosomes are extracted from full term, planned C Section, Amniotic fluid. The extracted exosome solution is derived from amniotic fluid and contains over 300 soluble proteins as growth factors, cytokines and chemokines, extracellular matrix proteins as fibronectin and collagen, structural molecules as hyaluronic acid, Nanoparticles as extracellular vesicles, exosomes and surfactants proteins, valuable lipids, micro-RNA, messenger-RNA, and cytokines.

Exosome therapy, according toexperts, is a highly targeted, flexible treatment believed to help inflammatory conditions like COPD, Long Covid, musculoskeletal injuries, osteoarthritis, and chronic pain.

Try to think of Stem Cells as microchips in a computer. Exosomes are like the software.

South Florida-basedOrganicell Regenerative Medicine Inc.OCEL is a company that is a pioneer in the exosome space. Their products are designed to operate like software for the computers of our body known as cells. However, the software Organicell uses is naturally occurring and unaltered. Organicell extracts its exosomes from what is believed to be one of the most naturally healing fluids on the planet, amniotic fluid. The software/exosomes in this fluid reminds the body what it used to do when it was young.

To put things plainly, the software (exosomes) is a set of instructions, data or programs used to operate the computers (cells) and execute specific tasks, while a computer-chip (stem cells) are used more as building blocks in regenerative medicine.

The potential benefits of Organicells products could be enormous. For example, the company's investigational productZofinis an acellular, non-HCT/P biologic, currently being studied in clinical trials. The company accomplished the difficult task of an approved investigational new drug (IND)from the U.S. Food and Drug Administration (FDA) which lead to approved clinical trials..

Zofin is derived from perinatal sources and is manufactured to retain the naturally occurring nanoparticles andmicroRNAswithout manipulation or adding or combining any other substance.

Zofin is currently being studied in FDAPhase I/II clinical trials for COVID-19, Long Covid, Chronic Obstructive Pulmonary Disease (COPD), and ready to begin a trial for Osteoarthritis of the knee.

Below are the results that were published on the COVID patients treated with Zofin under eIND approval. The important items in the chart are the key biomarkers that measure inflammation: IL-6 and CRP as well as the chest X Rays that show the structural difference in the lungs over time.

Organicellreports that its mission is to be the first company to prove the efficacy ofextracellular vesicles (EV's) a.k.a exosomes on inflammatory ailments. Organicell has two active FDA approved clinical trials for Long Covid and COPD.

The company says through its ground-breaking research in the field of nanotechnology, specifically perinatal-derived EVs, it has created the drug candidate, Zofin, that could be the next frontier of regenerative biologic therapeutics.

Organicells proprietary products biological representation is allogenic amniotic fluid (secreted body fluid, non-HCT/Ps), which is an acellular product derived from human amniotic fluid (HAF). The product contains no addition or combination of any other substance or diluent during production.

Moreover, the product quality assurance is seemingly unmatched in the regenerative medicine space. the donor from whom this product was derived has been tested and found negative for the following: HBsAg (Hepatitis B Surface Antigen), HBcAb (hepatitis B core antibody), HCV (hepatitis C antibody), HIV I/II-Ab (Antibody to Human Immunodeficiency Virus Types 1 and 2), Syphilis detection test, HIV NAT (HIV Nucleic Acid Test), and HCV NAT (HCV Nucleic Acid Test).

Additional donor screening tests may have been performed on the donor. If additional tests for Human Immunodeficiency Virus, Hepatitis B, Hepatitis C or Syphilis were performed, the results were reviewed and found to be NEGATIVE.

Additional tests for other communicable diseases, such as West Nile Virus, T. Cruzi, Cytomegalovirus and Epstein Barr Virus may have been performed. The results of all additional communicable disease tests have been evaluated by the Medical Director and have been found acceptable according to regulations, standards and Standard Operating Procedures (SOPs).

Donor screening tests are performed by laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and American Association of Blood Banks (AABB) using FDA licensed tests when available performed by VRL Laboratories.

The donor is selected based on medical and social history which meets the Standards of the American Association of Tissue Banks (AATB) United States Public Health Service (USPHS), and the Federal Food and Drug Administration (FDA).

Donor suitability was determined by the Manufacturing Facilities Medical Directors (Organicell Regenerative Medicine, 1951 NW 7th Ave, Suite 300, Miami, FL 33136). Organicell Factor X is manufactured for clinical use under cGMP-compliant manufacturing facility, to control potency and purity of the product.

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