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Advances and challenges of the cell-based therapies among diabetic patients – Journal of Translational Medicine – Journal of Translational Medicine

By Stem Cell Treatment

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Advances and challenges of the cell-based therapies among diabetic patients - Journal of Translational Medicine - Journal of Translational Medicine

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

By Stem Cell Treatment

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

Yale Cancer Center Earns International Reaccreditation for Expertise in CAR T-cell Therapy and Stem Cell … – Yale School of Medicine

By Stem Cell Medicine

Yale Cancer Center (YCC) and Smilow Cancer Hospital (SCH) have again received an internationally recognized accreditation for cellular therapy and stem cell transplantation from the Foundation for the Accreditation of Cellular Therapy (FACT), giving patients lifesaving cancer treatment options in Connecticut. SCH is the only cancer hospital in the state offering these therapies, including chimeric antigen receptor (CAR) T-cell therapy. A new cellular therapy, tumor infiltrating lymphocyte (TIL) therapy, will be available soon for melanoma.

FACT accreditation has evolved into a necessary qualification to be accepted and competitive in the field of cellular therapy, said Stuart Seropian, MD, clinical director and lead physician of the stem cell transplant program at YCC and SCH. This accreditation shows that we strive to achieve the highest quality care for cellular therapy treatment programs.

YCC and SCH uphold the most rigorous standards in every aspect of transplantation and cellular therapy from clinical care to donor management, cell collection, processing, storage, transportation, administration, and cell release. There are currently 310 FACT-accredited institutions worldwide.

What are cellular therapies?

SCH is one of a select group of hospitals and cancer centers that offer CAR T-cell therapy (a type of immune effector cell therapy) to patients with solid tumors, relapsed/refractory melanoma, and even disease areas beyond oncology.

CAR T-cell therapy is a relatively new and highly personalized type of immunotherapy drug that uses a patients synthetically modified T cells a type of white blood cell to kill cancer cells. Dr. Seropian said CAR T is an exciting new form of immunotherapy that is proving effective in patients with certain recurrent or resistant blood cancers.

YCC and SCH will soon offer (TIL) therapy cellular therapy for melanoma that was recently approved by the Food and Drug Administration. Doctors grow a large number of tumor infiltrating lymphocyte cells in the lab from a sample of a patients own tumor and return the cells to the body to seek out and combat tumors.

What is stem cell transplantation?

A stem cell transplant, which is also known as a bone marrow transplant, is a medical procedure in which healthy stem cells from a donor replace damaged or diseased bone marrow. The healthy stem cells can then develop into new, healthy bone marrow and blood cells. The procedure can be used to treat various cancers of the blood, bone marrow, or lymph system such as leukemia or lymphoma.

YCC physicians at SCH offer transplantation, using compatible donor stem cells, which is known as an allogeneic transplant or using a patients own stem cells, which is known as an autogulous transplant.

A leader in cellular therapy and stem cell transplant

The stem cell transplant program at YCC and Smilow first received FACT accreditation in 2003, and reaccreditation occurs every three years.

YCC and SCH are members of the National Marrow Donor Program. This program tracks data on patients who have received a transplant at accredited United States Transplant Centers. Data from the program shows that after one year, patients who receive a stem cell transplant at Smilow Cancer Hospital have a 9 percent higher expected one year survival rate than the national rate of 63%.

Smilow also ranks as a top hospital in U.S. News & World Report as one of the "America's Best Hospitals" for leukemia, lymphoma, and myeloma three conditions for which ceullar therapy and stem cell transplants may be necessary.

To make an appointment with a Yale Cancer Center physician, click here.

About Yale Cancer Center and Smilow Cancer Hosptial

Yale Cancer Center combines a tradition of innovative cancer treatment and quality care for our patients. A National Cancer Institute (NCI) designated comprehensive cancer center since 1974, Yale Cancer Center is one of only 56 such centers in the nation and the only one in Connecticut. Yale Cancer Center members include national and internationally renowned scientists and physicians at Yale School of Medicine and Smilow Cancer Hospital. This partnership enables the Center to provide the best approaches for prevention, detection, diagnosis, and treatment for cancer.

Smilow Cancer Hospital at Yale New Haven Health is one of the nations pre-eminent cancer hospitals, Connecticuts largest provider of cancer care, and the only comprehensive cancer facility in the Northeast bringing together both inpatient and outpatient care in one hospital. In addition to the flagship Smilow Cancer Hospital in New Haven, Smilow offers state-of-the-art cancer services at 15 other locations throughout the region. Partnering with Yale Cancer Center, Smilow Cancer Hospital offers the very latest care, delivered by some of the nations most prominent and highly respected physicians and nurses. A leader in groundbreaking academic medicine, Smilow provides access to more than 300 clinical trials bringing innovation and new hope to patients each year, including access to Phase I trials.

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Yale Cancer Center Earns International Reaccreditation for Expertise in CAR T-cell Therapy and Stem Cell ... - Yale School of Medicine

How hematopoietic stem cells retain their regenerative potential – Drug Target Review

By Stem Cell Medicine

Researchers found that genetic depletion of cyclophilin A results in stem cells distinctively lacking intrinsically disordered proteins.

Scientists at Baylor College of Medicine have discovered the enzyme cyclophilin A is crucial for hematopoietic stem cells (HSCs) to retain their regenerative potential and avert the effects of aging.

Although HSCs normally remain dormant within bone marrow, they can activate and replenish blood cells continuously, maintaining a fairly youthful profile throughout the life of an organism. Corresponding author Dr Andr Catic, assistant professor and CPRIT Scholar in Cancer Research in the Huffington Center on Aging at Baylor, explained: A driving force of cellular aging is the accumulation of proteins that have reached the end of their useful lifeWith age, proteins tend to misfold, aggregate and accumulate inside the cell, which leads to toxic stress that can disrupt cell function.

Cells that often engage in cell division, such as progenitor cells, can dispose of protein aggregates through dilution. Contrastingly, long-lived HSCs, which do not divide often, face the issue of the accumulation of misfolded proteins and resulting toxic stress. However, HSCs stay unaffected to aging.

Dr Lauren Maneix, co-first author of the work and at theCatic labwhile working on this study added: Understanding the molecular mechanisms that contribute to HSC aging not only contributes to the field of normal HSC biology, but also may have significant clinical relevance for cancer treatment.

Past studies have shown that mammalian cells express several hundreds of molecular chaperones, proteins that preserve or alter the three-dimensional (3D) conformation of existing proteins. One of the most abundant chaperones, cyclophilins, have been implicated in the aging process, but the mechanisms by which they affect cellular proteins has not been studied.

The researchers, working with mice, first characterised the protein content of HSCs and found that cyclophilin A is a prevalent chaperone. Further experiments demonstrated that the expression of cyclophilin A was greatly decreased in aged HSCs, and genetically eliminating cyclophilin A accelerated natural aging in the stem cell compartment. Contrastingly, reintroducing cyclophilin A into aged HSCs improved their function. Therefore, these results support cyclophilin A as a crucial factor in the longevity of HSCs.

Then, the team investigated the proteins with which cyclophilin A interacts, preserving their stability. Dr Catic commented: We found that proteins enriched in intrinsically disordered regions are frequent targets of the chaperone.

Intrinsically disordered proteins naturally change their 3D conformation to interact with different proteins, nucleic acids or other molecules. Thus, proteins rich in intrinsically disordered regions regulate many cellular processes by promoting specific activities between molecules. Dr Catic explained: Due to their flexible nature, intrinsically disordered proteins are inherently prone to aggregation. Cyclophilin A supports these proteins in fulfilling their functions and simultaneously prevents them from clumping.

Furthermore, the results suggest that cyclophilin A interacts with intrinsically disordered proteins from the moment of their synthesis. As these proteins are being made, cyclophilin A makes sure they keep the appropriate conformations and are maintained at sufficient levels, Dr Catic said. Genetic depletion of cyclophilin A results in stem cells distinctively lacking intrinsically disordered proteins.

For the first time, our study showed that producing disordered proteins and maintaining the structural diversity of the proteins in a cell plays a role in HSC aging, Dr Maneix concluded.

This study was published in Nature Cell Biology.

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How hematopoietic stem cells retain their regenerative potential - Drug Target Review

First Patient Begins Newly Approved Sickle Cell Gene Therapy – The New York Times

By Stem Cell Medicine

On Wednesday, Kendric Cromer, a 12-year-old boy from a suburb of Washington, became the first person in the world with sickle cell disease to begin a commercially approved gene therapy that may cure the condition.

For the estimated 20,000 people with sickle cell in the United States who qualify for the treatment, the start of Kendrics monthslong medical journey may offer hope. But it also signals the difficulties patients face as they seek a pair of new sickle cell treatments.

For a lucky few, like Kendric, the treatment could make possible lives they have longed for. A solemn and shy adolescent, he had learned that ordinary activities riding a bike, going outside on a cold day, playing soccer could bring on episodes of searing pain.

Sickle cell always steals my dreams and interrupts all the things I want to do, he said. Now he feels as if he has a chance for a normal life.

Near the end of last year, the Food and Drug Administration gave two companies authorization to sell gene therapy to people with sickle cell disease a genetic disorder of red blood cells that causes debilitating pain and other medical problems. An estimated 100,000 people in the United States have sickle cell, most of them Black. People are born with the disease when they inherit the mutated gene for the condition from each parent.

The treatment helped patients in clinical trials, but Kendric is the first commercial patient for Bluebird Bio, a Somerville, Mass., company. Another company, Vertex Pharmaceuticals of Boston, declined to say if it had started treatment for any patients with its approved CRISPR gene-editing-based remedy.

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First Patient Begins Newly Approved Sickle Cell Gene Therapy - The New York Times

Ozzy Osbourne receiving stem cell treatments amid health problems – New York Daily News

By Stem Cell Medicine

Ozzy Osbourne has fully embraced modern medicine amid his ongoing struggles with his health.

The 75-year-old Grammy winner revealed this week hes receiving stem cell treatments after disclosing in November that doctors discovered a tumor on his vertebrae while undergoing his fourth spinal surgery.

Ive just come back from the doctor after having some stem cells put in me, Osbourne told his Ozzy Speaks co-host Billy Morrison on their SiriusXM radio show. The thing is, you have it, and you go, I dont feel that great, but I dont know what it would be like if I didnt have it.

According to The Prince of Darkness, the treatments which he described as kind of like a super fing stem cell are pretty expensive as well.

Osbourne said hes due to return for follow-up treatment in about six months.

Morrison disclosed he also underwent stem cell treatments for hip problems that caused him difficulty getting into his car and out of bed: I couldnt tie my own shoelaces, so I had injections direct to the site, five of them, and its gone. It fixed it.

Last July, Osbourne announced he was pulling out as headliner of the inaugural three-day Power Trip Festival in Indio, Calif. due to ongoing health issues from his recent spine injury.

Months before, the former Black Sabbath frontman announced his retirement from touring as he canceled European tour dates, saying he wasnt well enough to perform due to a major accident in which he damaged his spine.

In 2020, he went public with his Parkinsons disease, which was diagnosed in 2003.

Last week, it was announced that the bat-biting Crazy Train singer will be inducted into the 2024 Rock and Roll Hall of Fame class as a solo artist, marking his second entry following Black Sabbaths 2006 induction.

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Ozzy Osbourne receiving stem cell treatments amid health problems - New York Daily News

UB Dental Researcher to Study Stem Cell Treatment for Root Canals – Oral Health

By Stem Cell Medicine

iStock

A University at Buffalo professor has received a $400,000 grant to study strategies for repairing damaged teeth.

Camila Sabatini, DDS, PhD, is an associate professor of restorative dentistry in the School of Dental Medicine. She will be collaborating with Techung Lee,PhD, associate professor of biochemistry in the Jacobs School of Medicine and Biomedical Sciences and Frank Scannapieco, PhD, SUNY Distinguished Professor of Oral Biology.

The selective four-year grant is attached to the Harold Amos Medical Faculty Development Program (AMFDP) award from theRobert Wood Johnson Foundation. Sabatini was the only dentist in the selection of scholars for this year.

Sabatinis research proposal involved investigating ways to use stem cells of dental origin to promote the repair of damaged teeth potentially avoiding the need for a root canal, shared UB in a recent press release.

Sabatini points out that stem cells have been used for tissue regeneration for years yet not enough has been done with this concept and dentistry, with the use of synthetic materials outdated.

Read more on this story from UB.

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Pacira BioSciences, Inc. Announces Proposed Offering of $250.0 Million Aggregate Principal Amount of Convertible Senior Notes

By Global News Feed

TAMPA, Fla., May 08, 2024 (GLOBE NEWSWIRE) -- Pacira BioSciences, Inc. (Nasdaq: PCRX) today announced that it intends to offer, subject to market and other conditions, $250.0 million aggregate principal amount of convertible senior notes due 2029 (the “notes”) in a private placement to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Pacira also intends to grant the initial purchasers of the notes an option to purchase, for settlement within a period of 13 days from, and including, the date the notes are first issued, up to an additional $37.5 million aggregate principal amount of notes.

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Pacira BioSciences, Inc. Announces Proposed Offering of $250.0 Million Aggregate Principal Amount of Convertible Senior Notes

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