BioRestorative Therapies Enhances Preclinical Metabolic Program with a Novel Exosome-Based Biologic Targeting … – GlobeNewswire

New therapeutic candidate developed using Companys patented ThermoStem platform

Candidate has potential to serve as an adjuvant to existing pharmaceuticals that are FDA approved and marketed towards weight loss

DMF submission and commencement of first-in-human studies targeted for before the end of 2024

Expanding the use of ThermoStem may open the door to big pharma partnership opportunities

MELVILLE, N.Y., May 08, 2024 (GLOBE NEWSWIRE) -- BioRestorative Therapies, Inc. (BioRestorative, BRTX or the Company) (NASDAQ:BRTX), a clinical stage company focused on stem cell-based therapies, today announced its development of a novel exosome-based biologic program targeting obesity.

BioRestorative currently anticipates initiating the formal U.S. Food and Drug Administration (FDA) process for this ThermoStem-based therapeutic candidate by filing a Drug Master File (DMF) in the third quarter of 2024. The Company aims to initiate first-in-human clinical studies before the end of the year.

Exosomes are small extracellular vesicles secreted by various cells, including stem cells. They are understood to be important mediators of intercellular communication, and have been found to play a role in adipose (fat) metabolism by transporting cargo, such as non-coding RNAs (ncRNA), proteins, and other factors that may impact weight loss. Previously published peer-reviewed preclinical data from a study conducted in collaboration with the University of Utah School of Medicine demonstrated that functional brown adipose derived stem cells, formulated using BioRestoratives proprietary ThermoStem platform, produced significant reductions in weight (consistent with losses achieved by GLP1 drugs) and blood glucose levels in a diet induced obesity model in mice.

BioRestoratives ThermoStem platform has a comprehensive portfolio of issued patents that cover both the U.S. and international markets. This broad intellectual property portfolio can be leveraged across drugs that are currently approved and marketed for weight loss, potentially opening the door to future big pharma partnership opportunities for the Company.

We believe that our proprietary ThermoStem technology platform has immense potential to develop both best-in-class and first-in-class therapies to treat obesity, such as this exosome-based biologic candidate, said Lance Alstodt, BioRestoratives Chief Executive Officer. While tremendous progress has been made in the fight against obesity, there is no question that significant unmet need remains. As an adjuvant to approved and marketed weight loss drugs, we believe that our new therapeutic candidate may allow for lower dosing, as well as prevent or minimize potential of muscle mass loss and negative cardiovascular effects.

About BioRestorative Therapies, Inc.

BioRestorative (www.biorestorative.com) develops therapeutic products using cell and tissue protocols, primarily involving adult stem cells. As described below, our two core clinical development programs relate to the treatment of disc/spine disease and metabolic disorders, and we have also recently begun offering BioCosmeceutical products:

Disc/Spine Program (brtxDISC): Our lead cell therapy candidate,BRTX-100,is a product formulated from autologous (or a persons own) cultured mesenchymal stem cells collected from the patients bone marrow. We intend that the product will be used for the non-surgical treatment of painful lumbosacral disc disorders or as a complementary therapeutic to a surgical procedure. TheBRTX-100production process utilizes proprietary technology and involves collecting a patients bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient procedure,BRTX-100is to be injected by a physician into the patients damaged disc. The treatment is intended for patients whose pain has not been alleviated by non-invasive procedures and who potentially face the prospect of surgery. We have commenced a Phase 2 clinical trial usingBRTX-100to treat chronic lower back pain arising from degenerative disc disease.

Metabolic Program (ThermoStem): We are developing cell-based therapy candidates to target obesity and metabolic disorders using brown adipose (fat) derived stem cells (BADSC) to generate brown adipose tissue (BAT), as well as exosomes secreted by BADSC. BAT is intended to mimic naturally occurring brown adipose depots that regulate metabolic homeostasis in humans. Initial preclinical research indicates that increased amounts of brown fat in animals may be responsible for additional caloric burning as well as reduced glucose and lipid levels. Researchers have found that people with higher levels of brown fat may have a reduced risk for obesity and diabetes.BADSC secreted exosomes may also impact weight loss.

BioCosmeceuticals: We operate a commercial BioCosmeceutical platform. Our current commercial product, formulated and manufactured using our cGMP ISO-7 certified clean room, is a cell-based secretome containing exosomes, proteins and growth factors. This proprietary biologic serum has been specifically engineered by us to reduce the appearance of fine lines and wrinkles and bring forth other areas of cosmetic effectiveness. Moving forward, we also intend to explore the potential of expanding our commercial offering to include a broader family of cell-based biologic aesthetic products and therapeutics via Investigational New Drug (IND)-enabling studies, with the aim of pioneering U.S. Food and Drug Administration (FDA)-approvals in the emerging BioCosmeceuticals space.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, and such forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. You are cautioned that such statements are subject to a multitude of risks and uncertainties that could cause future circumstances, events or results to differ materially from those projected in the forward-looking statements as a result of various factors and other risks, including, without limitation, those set forth in the Company's latest Form 10-K filed with the Securities and Exchange Commission. You should consider these factors in evaluating the forward-looking statements included herein, and not place undue reliance on such statements. The forward-looking statements in this release are made as of the date hereof and the Company undertakes no obligation to update such statements.

CONTACT:

Email:ir@biorestorative.com

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BioRestorative Therapies Enhances Preclinical Metabolic Program with a Novel Exosome-Based Biologic Targeting ... - GlobeNewswire

Clonal hematopoiesisderived therapy-related myeloid neoplasms after autologous hematopoietic stem cell transplant … – Nature.com

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Clonal hematopoiesisderived therapy-related myeloid neoplasms after autologous hematopoietic stem cell transplant ... - Nature.com

GMP Cell Therapy Consumables Market Expected to Grow at a CAGR of 29.3% From 2024 to 2031 – BioSpace

Global GMP Cell Therapy Consumables Market is valued at US$ 17.98 Mn in 2023, and it is expected to reach US$ 139.19 Mn by 2031, with a CAGR of 29.3% during the forecast period of 2024-2031.

GMP (Good Manufacturing Practice) cell therapy consumables are materials used in the production and processing of cell-based therapies that meet stringent regulatory quality and safety requirements. The market for GMP cell therapy consumables is driven by a number of reasons, including the expansion and development of the cell therapy sector, regulatory requirements, and technological advances.

Recent Developments:

Download Free Report Sample Pages: https://www.insightaceanalytic.com/request-sample/1929

Market Dynamics:

Market Drivers:

The rising prevalence of chronic diseases is a major factor driving demand for GMP cell therapy consumables. Current research activities focusing on cell therapy as a possible treatment for chronic illnesses highlight the growing need for high-quality consumables to ensure the efficacy of clinical trials and therapy administration. Moreover, the market's growth is also being aided by new advancements in drug discovery, which are fueled by cutting-edge technologies in molecular biology, genetics, and high-throughput screening. The approval of multiple new pharmacological entities indicates a good trend in drug discovery activities, which will expand the market for GMP cell therapy consumables.

Challenges:

Achieving and sustaining GMP compliance necessitates large investments in infrastructure, quality control procedures, and employee training. The severe regulatory requirements increase the cost of manufacturing GMP-compliant consumables, potentially leading to increased prices for these products. Smaller businesses and academic organizations with insufficient financial means may find it difficult to cope. Additionally, the production processes for GMP cell therapy consumables can involve many phases and necessitate specialized equipment and knowledge. Manufacturers may face challenges in increasing production efficiency while maintaining product quality and regulatory compliance.

Regional Trends:

The North America GMP cell therapy consumables market is likely to register a significant revenue share and develop at a rapid CAGR in the near future. This is due to a growth in medication development, R&D activity, and strategic collaborations among market players. Furthermore, rising rates of cancer, infectious diseases, autoimmune disorders, and neurological disorders have increased demand for personalized treatment and regenerative medicine, driving the expansion of the GMP cell therapy consumables market. The United States has a sizable share of the North American GMP cell therapy consumables industry. Rising government health expenditure, increased pharmaceutical industry development, and rising demand for innovative pharmaceuticals as a result of the incidence of numerous infectious diseases are all driving market expansion.

Segmentation of GMP Cell Therapy Consumables Market-

GMP Cell Therapy Consumables Market- By Product

GMP Cell Therapy Consumables Market- By Cell Therapy Type

GMP Cell Therapy Consumables Market- By Process

GMP Cell Therapy Consumables Market- By End-user

GMP Cell Therapy Consumables Market- By Region

North America-

Europe-

Asia-Pacific-

Latin America-

Middle East & Africa-

Talk with Experts Panel on the GMP Cell Therapy Consumables Market Report @ https://calendly.com/insightaceanalytic/30min?month=2024-02

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GMP Cell Therapy Consumables Market Expected to Grow at a CAGR of 29.3% From 2024 to 2031 - BioSpace

Alzheimer’s trial doses patients with stem cell treatment directly to brain – Clinical Trials Arena

California-based Regeneration Biomedical has dosed the first patient has been dosed in a first-in-human trial of its autologous stem cell treatment, RB-ADSC, for patients with mild-to-moderate Alzheimers disease.

The Phase I trial (NCT05667649) of the candidate bypasses the blood-brain barrier (BBB) which most approved and investigated treatments pass through, with Regenerations stem cell treatment, RB-ADSC, being injected directly into the ventricular system.

RB-ADSCs are Wnt-activated adipose-derived stem cells obtained from a patients own adipose tissue. The cells are cultured and expanded in vitro, selected for Wnt expression, and then reintroduced into the patients brain.

The Phase I trial is an open-label, single-arm study which will enroll nine patients over one year. Patients will be randomised into a 3 + 3 dose escalation design to evaluate the safety of autologous RB-ADSC infused into the lateral ventricles of the brain in subjects with mild-to-moderate AD, as well as to determine a recommended dose for a potential Phase II clinical trial.

Secondary endpoints include AD clinical assessments and biochemical and anatomical biomarkers. Each patient will be followed for up to 12 months after treatment.

Founder of Regeneration Biomedical, Christopher Duma, said: Stem cells have represented a novel approach to treatment, but evidence of efficacy has been elusive because systemically administered cells are unable to bypass the BBB and enter the brain. Our RB-ADSC product candidate is designed to overcome the BBB by delivering potentially efficacious stem cells directly to the brain.

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Duma said the company hopes that the therapy will turn on the stem cells that are sitting dormant in the brain to initiate repair and replacement of damaged neurons.

The company has plans to investigate the therapy in other neurodegenerative diseases at Phase II including multiple sclerosis, Parkinsons disease, traumatic brain injury and amyotrophic lateral sclerosis.

Alzheimers disease is a chronic neurodegenerative disease that usually starts slowly in people aged over 65 and worsens over time. It is the most common cause of dementia, accounting for 60% to 70% of all cases. Estimates suggest that as many as 12.4 million patients in the US could have the disease by 2050.

Currently, the only disease-modifying treatments on the market are amyloid targeting treatments Leqembi (lecanemab) and Aduhelm (aducanemab), however, Biogen has decided to discontinue Aduhelm, returning the rights for the drug back to the original developer Neurimmune.

Eli Lilly was hoping that its amyloid targeting therapy donanemab would be on the market by now however it has faced a couple of set back by the US Food and Drug Administration (FDA), with the agency now wanting an Adcomm to further evaluate the unique trial design.

Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.

Editorial content is independently produced and follows thehighest standardsof journalistic integrity. Topic sponsors are not involved in the creation of editorial content.

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Alzheimer's trial doses patients with stem cell treatment directly to brain - Clinical Trials Arena

Celebrities Quietly Paying Huge Amounts for Anti-Aging Stem Cell Therapy That May Cause Gruesome Side Effects – Yahoo Canada Shine On

Age is just a number. Or, in the era of immortality-obsessed elites, it's just the number of bizarre, supposedly youth-preserving stem cell treatments you can afford.

One celebrity to recently come clean about their use of these experimental treatments is British actor and comedian John Cleese. In an interview with Saga Magazine, the 84-year-old revealed that for the past two decades, he's been spending around 17,000 the equivalent of about $21,000 a year on a private stem cell therapy to stave off aging.

Sure, the Monty Python co-creator is looking pretty good for his age. But experts warn that not only are the purported benefits of these therapies unproven, they may even be outright damaging to our bodies, possibly leading to gruesome outcomes like cancer.

The private clinics that provide these treatments, they warn, operate in "regulatory gray zones" in countries like the US and Switzerland where Cleese gets his treatment preying on the public's lack of understanding on the science behind the technology.

"These clinics may be operating outside of regulatory oversight and scientific collaboration, and do not publish the protocols or outcomes of what they are doing to patients that pay for their services," Anna Couturier at the European Consortium for Communicating Gene and Cell Therapy Information (EuroGCT) told The Telegraph.

Of course, there's a reason that stem cells have their reputation as a miracle of science. Not only are they remarkably good at renewing themselves, the so-called "pluripotent" ones are capable of developing into virtually any kind of cell in the human body. They're basically jacks of all trades, and it's these properties make them ideal for regenerating damaged or even lost tissue.

Perhaps one day advances in this field will let us regrow limbs like frogs. Even now, stem cells already have a well established use in treating leukemia patients by being transplanted into diseased bone marrow.

"You're looking to get rid of the disease and then replace the blood system with some fresh stem cells," Jon Frampton, a stem cell biologist at the University of Birmingham, told The Telegraph. "It's tried and tested and proven to work."

Things get shady beyond these limited proven uses, though. Some anti-aging treatments purport to make you look younger by replenishing the collagen in your face despite there being limited evidence to support them and the potential downsides don't sound worth the risk.

"If put into the wrong context without the right prompts and cues, stem cells do what they're capable of doing but in a very random way," Frampton told The Telegraph. "You can get a tumor called a teratoma, because the stem cells grow a lot and form a lump."

There's also considerable risks about the way these stem cells are administered.

"If the product is not sterile, it can lead to inflammation and, in worst case scenarios, septic shock," Darius Widera, a professor of stem cell biology and regenerative medicine at the University of Reading, told The Telegraph. "Many patients have been harmed by these gray zone clinics."

It's not that stem cells can't live up to the sky high potential we've predicted for them. But we should be skeptical about rushing to use them in these dubious, supposedly age-defying applications. Whatever your anxieties about getting old, it's best to let the science catch up first.

More on stem cells: Scientists Grow Teeny Tiny Testicles in Laboratory

Excerpt from:
Celebrities Quietly Paying Huge Amounts for Anti-Aging Stem Cell Therapy That May Cause Gruesome Side Effects - Yahoo Canada Shine On

Stem cells improve memory, reduce inflammation in Alzheimer’s mouse brains – Newswise

BYLINE: Noah Fromson

Newswise When people think of Alzheimers Disease and possible treatment, amyloid and the accumulation of plaques that invade the cerebral cortex is often brought up first.

However, scientists are finding that Alzheimers is influenced by many factors, including neuroinflammation and disrupted metabolism.

By transplanting human neural stem cells, researchers led by Michigan Medicine improved memory and reduced neuroinflammation in a mouse model of Alzheimers Disease, suggesting another avenue for potential treatment.

The results are published inFrontiers in Aging Neuroscience.

The beneficial effects of transplanting human neural stem cells within the brains of Alzheimer's Disease miceoccurred despite amyloid plaque levels remaining unchanged, which lends further evidence that strategies targeting neuroinflammation may be a promising therapeutic strategy, independent of amyloid plaques, saidlead authorKevin Chen, M.D., clinical assistant professor of neurosurgery and neurology at Michigan Medicine.

Additionally, the treatment was associated with normalized inflammation in the microglia, which are the innate immune cells of the brain that become activated with Alzheimers Disease. As the disease progresses, microglia and their inflammatory signaling is thought to contribute to neuron loss.

A team at Michigan MedicinesNeuroNetwork for Emerging Therapies transplanted neural stem cells into the memory centers of transgenic mice that expressed mutations associated with familial Alzheimers Disease. They had both the test mice and control mice perform a task called the Morris water maze to assess spatial memory and learning eight weeks after transplant.

Investigators found that Alzheimers disease mice transplanted with stem cells had their learning curves restored to resemble the control mice with normal learning and memory.

Additional testing through spatial transcriptomics a method to measure gene expression in areas across the brain revealed over 1,000 differently expressed genes that were normalized in the memory centers of the Alzheimers Disease mice after transplantation.

In analyzing the gene expression changes specifically in microglia, the genetic markers linked to progression of Alzheimers Disease were also restored to levels close to control mice. This suggested a reduction in neuroinflammation and disease progression.

Researchers say the improvements reported after stem cell transplantation must be further studied in mice before advancing to larger animals and, eventually, humans.

Our research is incredibly important and continues to support the promise of stem cell therapies in neurodegenerative diseases, according tosenior authorEva Feldman, M.D., Ph.D.,director of the ALS Center of Excellence at U-M and James W. Albers Distinguished University Professor at U-M.

These preclinical studies are the required first step on the road to stem cell therapies.

Additional authors:Include Mohamed H. Noureldein, Ph.D., Lisa M. McGinley, Ph.D., John M. Hayes, Diana M. Rigan, Jacquelin F. Kwentus, Shayna N. Mason, Faye E. Mendelson, all of University of Michigan, and Masha G. Savelieff, CRED, of University of North Dakota.

Funding:This research was supported by the National Institutes of Health, The Handleman Emerging Scholar Program, the NeuroNetwork for Emerging Therapies, The Robert E. Nederlander Sr. Program for Alzheimers Research, the Sinai Medical Staff Foundation and an Alzheimer's Association grant.

Michigan Research Core:Advanced Genomics Core

Citation:Human neural stem cells restore spatial memory in a transgenic Alzheimers disease mouse model by an immunomodulating mechanism,Frontiers in Aging Neuroscience. DOI:10.3389/fnagi.2023.1306004

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Stem cells improve memory, reduce inflammation in Alzheimer's mouse brains - Newswise

Trial testing Parkinson’s cell therapy ANPD001 treats 1st patient – Parkinson’s News Today

A Phase 1/2 clinical trial dubbed ASPIRO thats testing Aspen Neurosciences ANPD001 a stem cell therapy candidate designed to replace the nerve cells that are lost in Parkinsons disease has dosed its first patient.

A first transplant was conducted at the Banner-University Medical Center Tucson by neurosurgeon Paul Larson, MD, the trials lead investigator, Aspen announced in a company press release

ASPIRO (NCT06344026), which was cleared by the U.S. Food and Drug Administration (FDA) last year, is testing the long-term safety and tolerability of the ANPD001 stem cell therapy when transplanted at two escalating doses in people with moderate to severe Parkinsons. The eligible study participants range in age from 50 to 70.

The initiation of this clinical trial is a major milestone in Aspens mission to develop and deliver personalized, regenerative neurologic therapies for people with unmet medical needs, starting with Parkinsons disease, said Damien McDevitt, PhD, president and CEO of Aspen Neuroscience.

To date, there is no disease-modifying therapy that can stop, replace or prevent the loss of dopamine neurons or slow the progression of Parkinsons, McDevitt said.

Additional trial goals will include assessments of the therapys early efficacy by measuring so-called on time, or periods when a patients symptoms are controlled by medications and the easing of motor symptoms. The trial is running at five clinical sites in the U.S.

Parkinsons is caused by the death of dopamine-producing neurons in the brains nigrostriatal dopaminergic pathway. That pathway includes the substantia nigra and the dorsal striatum, both involved in motor control. Dopamine is a major brain chemical messenger.

ANPD001 aims to replace the dopaminergic neurons that are lost in Parkinsons.

This experimental therapy for Parkinsons uses a type of stem cell called an induced pluripotent stem cell, or iPSC, which is able to generate nearly any type of cell in the body including dopamine-producing neurons. Its manufacturing is a three-step process.

The first step involves collecting skin cells from a patient, which are then modified in the lab and reprogrammed into iPSCs. The iPSCs are then provided with biochemical cues that guide them into transforming into dopamine neuronal precursor cells. These cells will eventually mature into dopamine-producing neurons once transplanted into patients.

The procedure is known as autologous because it uses a patients own cells.

This is the first use of the autologous approach in a formal clinical trial, saidLarson, also a professor of neurosurgery at the University of Arizona College of Medicine-Tucson.

Larson called it an honor to take part in ASPIRO, saying its an important study.

Parkinsons disease is the most common neurodegenerative movement disorder, primarily affecting the depletion of dopamine neurons in the midbrain, Larson said.

By the time of diagnosis, it is common for people with Parkinsons to have lost the majority of dopaminergic (DA) neurons in the nigrostriatal pathway, which leads to progressive loss of motor and neurological function, Larson said.

The enrolled participants expected to be nine in total were first remotely monitored via a digital health platform, by Rune Labs, as part of a Trial-Ready Cohort Screening study. The goal was to have a comprehensive view of the disease ahead of patient recruitment.

Also included in the trials additional goals, along with increased on time and reduced motor symptoms, is improvement in patients quality of life.

This first-in-human trial holds significant promise to investigate the ability of ANPD001 to improve the lives of people with moderate to advanced Parkinsons disease.

The trials primary phase is expected to be completed by next year, and patients will be assessed for five years post-transplant, with the use of imaging scans of the brain.

This first-in-human trial holds significant promise to investigate the ability of ANPD001 to improve the lives of people with moderate to advanced Parkinsons disease, said Edward Wirth III, MD, PhD, Aspens chief medical officer.

Our 2022 Trial Ready Cohort Screening Study has completed enrollment, and we plan to dose patients in the ASPIRO Phase 1/2a study this year, Wirth said.

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Trial testing Parkinson's cell therapy ANPD001 treats 1st patient - Parkinson's News Today

Rejuvenating the immune system by depleting certain stem cells – National Institutes of Health (NIH) (.gov)

At a Glance

The risk for serious infections rises with age, as peoples immune systems lose the ability to respond to novel infections. Part of the reason for this is that the types of hematopoietic stem cells (HSCs), which make the various types of blood cells, change with age.

Some HSCs, called myeloid-biased HSCs (my-HSCs) produce mostly myeloid cells, which include red blood cells, platelets, and most cells of the innate immune system. Others, called balanced HSCs (bal-HSCs), produce a healthy mix of myeloid and lymphoid cells, which include the T and B cells that make up the adaptive immune system.

The proportion of my-HSCs increases with age. Thisleads to more myeloid cells and fewer lymphoid cells. More myeloid cellsincreaseinflammation and bring an increased risk of atherosclerosis and myeloid-related diseases such as leukemia. Fewer lymphoid cellsreduces theability to fight infections. A research team led by Drs. Kim Hasenkrug and Lara Myers at NIH and Drs. Irving Weissman and Jason Ross at Stanford University School of Medicine explored whether reducing my-HSCs could restore a more youthful immune system in aged mice. The results appeared in Nature on March 27, 2024.

The team began by identifying proteins on the surface of mouse HSCs that are unique to my-HSCs. They then created antibodies against these proteins and used them to deplete my-HSCs in aged mice.

Depletingmy-HSCs reduced the effects of aging on the mouse immune system.Itincreased lymphoid progenitor cells, which give rise to T and B cells, in the bone marrow. Consequently, treated mice had more nave T cells and B cells in their blood than untreated mice. These cells allow the immune system to learn to recognize novel infections. Thetreatmentalsolowered levels of exhausted T cells and age-associated B cells, along with certain inflammatory markers.

When the researchers vaccinated aged mice with a live, weakened virus, those with depleted my-HSCs had a stronger T cell response than untreated mice. The treated mice also gained better protection against infection from the vaccination.

These findings could explain why older people are more vulnerable to infections such as SARS-CoV-2. Weakened adaptive immunity from fewer lymphoid cells makes it harder for them to fight off the infection. At the same time, increased myeloid cells cause harmful inflammation. The researchers noted that the genes that characterize my-HSCs in mice are also found in aged human HSCs. This suggests that my-HSC depletion might be used in humans to relieve certain age-associated health problems.

During the start of the COVID-19 pandemic, it quickly became clear that older people were dying in larger numbers than younger people, Weissman says. This trend continued even after vaccinations became available. If we can revitalize the aging human immune system like we did in mice, it could be lifesaving when the next global pathogen arises.

by Brian Doctrow, Ph.D.

Funding:NIHs National Institute of Allergy and Infectious Diseases (NIAID), National Cancer Institute (NCI), National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), and National Institute of General Medical Sciences (NIGMS); Virginia and D.K. Ludwig Fund for Cancer Research; Stanford University; Radiological Society of North America; Stanford Cancer Institute.

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Rejuvenating the immune system by depleting certain stem cells - National Institutes of Health (NIH) (.gov)

Man Paralyzed In Surfing Accident Regains Ability to Walk After Stem Cell Treatment – The Inertia

After a surfing accident left Chris Barr paralyzed from the neck down, stem cell treatment got him back on his feet again. Photo: Mayo Clinic

Seven years ago, Chris Barr went surfing at San Franciscos Ocean Beach, the same as hed done every weekend for a decade. It began as a day like any other, but it would end with a life-changing accident. Barr walked into the water that day, but when he fell on a wave, he broke his neck in eight places. He was paralyzed from the neck down. But after a miraculous stem cell trial at the Mayo Clinic, Barr is walking again.

He was so distraught over being paralyzed from the neck down as a result of his injuries, wrote Joel Streed for the Mayo Clinic, that the first thing he mouthed to his wife, Debbie, through the intubation tube when she arrived at his hospital bedside was a plea to take it all away.

Her husband asked the impossible of her. The first words he mouthed to me were Pull the plug, which was so shocking, she said.

Thankfully, Barrs mental state improved with time. A few days later, a friend of Barrs named Chris Whitewho was the one who pulled Barr out of the water on that fateful day came to visit him. Knowing Barr was in a dark place, he had some words of encouragement.

He said, Theres technology, new developments every day, Barr remembered. Why would you throw in the towel? Youve got nothing to lose.'

In the weeks following his injury, Barr underwent a battery of tests, surgeries, and therapies. He improved for the first six months, but then his process flatlined. Thats when a nuerosurgeon from the Mayo Clinic named Mohamad Bydon came to see him and offered him something he couldnt turn down: the chance to participate in a stem cell trial aimed at helping paralyzed people improve their mobility.

Stem cell treatments are still relatively new, but they show enormous promise.

Mesenchymal stem cells taken from the stomach fat of a patient with a spinal cord injury are given time to multiply in a cultured laboratory setting, according to the Mayo Clinic. Then they are injected into the patients lower back. The cells migrate to the site of the patients injury and help augment healing and any initial improvement in motor and sensory function the patient might have experienced after surgery.

Dr. Bydon emphasizes that the six-month wait is an important part of the stem cell recovery process.

We want to intervene when the physical function has plateaued, he said, so that we do not allow the intervention to take credit for early improvements that occur as part of the natural history with many spinal cord injuries.

After a few more months and consultations, Barr entered the Mayo Clinic to be patient number one in a clinical trial, including nine others, each with a variety of different spinal cord injuries. The trial tested the safety, side effects, and dosages of stem cells, and as of this writing, hasnt been approved by the Food and Drug Administration.

But the results were, quite frankly, astonishing. Barr told ABC that the effects were immediate.

I could feel it, he said of the hours after his first stem cell injection. I absolutely felt something in my legs.

From there, Barrs condition only continued to improve. The stem cells worked on repairing his injuries, and in the following months nearly everything got better. His scores on a grip and pinch strength test, a 10-meter walking test, and an ambulation test improved by 50 percent above his waist and 25 percent below.

Still, though, his recovery was and still is a long road, but the improvements Barr was seeing spurred him on. While Barrs response to the treatment were extraordinary, Dr. Bydon knows that it wasnt the norm.

Although some patients like Chris are super-responders, other patients are moderate responders or nonresponders, he said. But this trial will help us advance the field, so we can offer new treatments for patients with spinal cord injury.

Barr still does require a cane and a helping hand now and then to walk and go about his day-to-day business, but considering the fact that he was paralyzed from the neck down, the stem cell treatment was like a miracle.

I cant say it enough times that the stem-cell regimen and protocol offers hope, he said. The hopelessness of paralysis is just unlike anything you can imagine. And this is the hope.

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Man Paralyzed In Surfing Accident Regains Ability to Walk After Stem Cell Treatment - The Inertia

Antiviral cellular therapy for enhancing T-cell reconstitution before or after hematopoietic stem cell transplantation … – Nature.com

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Antiviral cellular therapy for enhancing T-cell reconstitution before or after hematopoietic stem cell transplantation ... - Nature.com