— First Web site Will Enroll First Affected person within the Scientific Examine–
MELVILLE, NY., June 13, 2022 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Firm” or “BioRestorative”) (NASDAQ: BRTX), a medical stage firm centered on stem cell-based therapies, right this moment introduced website initiation for its Section 2 medical trial concentrating on continual lumbar disc illness (cLDD). The Denver Backbone and Ache Institute is the primary medical website to be initiated. Extra chosen websites are anticipated to be initiated in 2022.
BioRestorative’s Section 2 trial is a double-blind managed, randomized research to guage the protection and preliminary efficacy of a single dose intradiscal injection of the Firm’s autologous investigational stem cell-based therapeutic, BRTX-100. A complete of as much as 99 eligible sufferers will likely be randomized at as much as 15 facilities in the USA to obtain both the investigational drug (BRTX-100) or management in a 2:1 trend.
“Presently there aren’t any accepted, cell-based therapies for cLDD. Whereas there may be encouraging information that implies that sufferers with cLDD may benefit from autologous stem cell transplants, the low oxygen micro-environment of the disc makes cell-based therapies difficult. BRTX-100 is manufactured beneath low oxygen situations and engineered to outlive this atmosphere,” stated Scott Bainbridge, M.D., Principal Investigator for the BRTX-100 trial at The Denver Backbone and Ache Institute. “Constructive proof-of-concept information on this trial might be disruptive and assist the potential applicability of BRTX-100 to different backbone and musculoskeletal issues the place low oxygen micro-environments are discovered.”
“We’re happy to provoke the primary of a number of websites throughout the USA that will likely be enrolling for the trial,” stated Lance Alstodt, Chief Govt Officer of BioRestorative Therapies. “Our websites have been rigorously reviewed and chosen and have medical experience in treating sufferers who may probably profit from BRTX-100. We sit up for working with the principal investigators and their medical trial groups.”
About BioRestorative Therapies, Inc.
BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic merchandise utilizing cell and tissue protocols, primarily involving grownup stem cells. Our two core packages, as described under, relate to the therapy of disc/backbone illness and metabolic issues:
- Disc/Backbone Program (brtxDISC™): Our lead cell remedy candidate, BRTX-100, is a product formulated from autologous (or an individual’s personal) cultured mesenchymal stem cells collected from the affected person’s bone marrow. We intend that the product will likely be used for the non-surgical therapy of painful lumbosacral disc issues or as a complementary therapeutic to a surgical process. The BRTX-100 manufacturing course of makes use of proprietary expertise and includes accumulating a affected person’s bone marrow, isolating and culturing stem cells from the bone marrow and cryopreserving the cells. In an outpatient process, BRTX-100 is to be injected by a doctor into the affected person’s broken disc. The therapy is meant for sufferers whose ache has not been alleviated by non-invasive procedures and who probably face the prospect of surgical procedure. Pursuant to authorization obtained from the Food and Drug Administration, we have now commenced a Section 2 medical trial utilizing BRTX-100 to deal with continual decrease again ache arising from degenerative disc illness.
- Metabolic Program (ThermoStem®): We’re growing a cell-based remedy candidate to focus on weight problems and metabolic issues utilizing brown adipose (fats) derived stem cells to generate brown adipose tissue (“BAT”). BAT is meant to imitate naturally occurring brown adipose depots that regulate metabolic homeostasis in people. Preliminary preclinical analysis signifies that elevated quantities of brown fats in animals could also be answerable for extra caloric burning in addition to decreased glucose and lipid ranges. Researchers have discovered that individuals with larger ranges of brown fats might have a decreased threat for weight problems and diabetes.
This press launch incorporates “forward-looking statements” throughout the which means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Change Act of 1934, as amended, and such forward-looking statements are made pursuant to the secure harbor provisions of the Non-public Securities Litigation Reform Act of 1995. You might be cautioned that such statements are topic to a large number of dangers and uncertainties that might trigger future circumstances, occasions or outcomes to vary materially from these projected within the forward-looking statements on account of varied elements and different dangers, together with, with out limitation, these set forth within the Firm’s newest Kind 10-Ok filed with the Securities and Change Fee and different public filings. You must contemplate these elements in evaluating the forward-looking statements included herein, and never place undue reliance on such statements. The forward-looking statements on this launch are made as of the date hereof and the Firm undertakes no obligation to replace such statements.
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