— Collaboration follows latest manufacturing/medical course of enhancements which have tripled month-to-month trial capability —
— Affected person enrollment anticipated to be accomplished in 2024 —
MELVILLE, N.Y., April 08, 2024 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (“BioRestorative”, “BRTX” or the “Firm”) (NASDAQ:BRTX), a medical stage firm targeted on stem cell-based therapies, right now introduced a collaboration with Galen Affected person Recruitment, Inc. (“Galen”) which, mixed with the latest growth of medical trial capability from roughly 10 to 30 members per thirty days, is predicted to assist speed up the completion of affected person enrollment within the ongoing Part 2 research of BioRestorative’s lead medical candidate, BRTX-100, in persistent lumbar disc illness (“cLDD”).
BRTX-100 is a novel cell-based therapeutic engineered to focus on areas of the physique which have little blood move. The protection and efficacy of BRTX-100 in treating cLDD is being evaluated in a Part 2, potential, randomized, double-blinded and managed research. A complete of as much as 99 eligible topics will probably be enrolled at as much as 16 medical websites in america. Topics included within the trial will probably be randomized 2:1 to obtain both BRTX-100 or placebo.
“The trade statistics might be sobering; round 80% of medical trials fail to satisfy their preliminary enrollment targets and timelines, with affected person recruitment being the one largest reason for trial delays,”1 stated Lance Alstodt, Chief Govt Officer of BioRestorative. “With that in thoughts, we’re assured that our partnership with an trade chief like Galen will assist us obtain our 2024 enrollment objectives by closing any gaps which will exist in our present recruitment course of.”
Reference
1 Brøgger-Mikkelsen M, Ali Z, Zibert JR, Andersen AD, Thomsen SF. On-line Affected person Recruitment in Medical Trials: Systematic Evaluate and Meta-Evaluation. J Med Web Res. 2020 Nov 4;22(11):e22179. doi: 10.2196/22179. PMID: 33146627; PMCID: PMC7673977.
About Galen Affected person Recruitment
Since 2006, Galen (www.galenrecruitment.com) has helped its purchasers deliver new medical improvements to market by cost-effective affected person recruitment options. Galen doesn’t consider in one-size matches all. It approaches every research with a recent perspective, and considers all the variables within the research enrollment equation – the analysis websites, research coordinators and, most significantly, the sufferers. This results in complete but versatile recruitment applications that take the guesswork out of attaining enrollment objectives.
About BioRestorative Therapies
BioRestorative Therapies, Inc. (www.biorestorative.com) develops therapeutic merchandise utilizing cell and tissue protocols, primarily involving grownup stem cells. Our two core applications, as described beneath, relate to the therapy of disc/spine 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 probably 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 entails amassing 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 doubtlessly face the prospect of surgical procedure. We have now commenced a Part 2 medical trial utilizing BRTX-100 to deal with persistent 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 further caloric burning in addition to diminished glucose and lipid ranges. Researchers have discovered that folks with greater ranges of brown fats could have a diminished threat for weight problems and diabetes.
Ahead-Wanting Statements
This press launch comprises “forward-looking statements” throughout the that means of Part 27A of the Securities Act of 1933, as amended, and Part 21E of the Securities Alternate Act of 1934, as amended, and such forward-looking statements are made pursuant to the protected harbor provisions of the Personal Securities Litigation Reform Act of 1995. You’re cautioned that such statements are topic to a large number of dangers and uncertainties that would trigger future circumstances, occasions or outcomes to vary materially from these projected within the forward-looking statements on account of varied components and different dangers, together with, with out limitation, these set forth within the Firm’s newest Type 10-Ok filed with the Securities and Alternate Fee. It’s best to contemplate these components 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.
CONTACT:
Electronic mail: ir@biorestorative.com
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