MELVILLE, N.Y.,, April 18, 2022 (GLOBE NEWSWIRE) — BioRestorative Therapies, Inc. (the “Firm” or “BioRestorative”) (NASDAQ: BRTX), a scientific stage firm targeted on stem cell-based therapies, right this moment introduced that it has chosen 10 of its 15 scientific websites for its Section 2 scientific trial concentrating on power lumbar disc illness.
BioRestorative’s Section 2 trial is a double-blind managed, randomized examine to judge the protection and preliminary efficacy of a single dose intradiscal injection of BRTX-100. A complete of as much as 99 eligible sufferers can be randomized at 15 facilities in america to obtain both the investigational drug (BRTX-100) or management in a 2:1 vogue.
The preliminary 10 scientific websites for the Section 2 are situated throughout america within the following cities:
- Greenwood Village, CO
- Tyler, TX
- Cleveland, OH
- Richmond, VA
- St. Petersburg, FL
- Tampa, FL (2 websites)
- North Charleston, SC
- Winston‐Salem, NC
- San Diego, CA
“We’re happy to have chosen our preliminary scientific websites and look ahead to initiating affected person enrollment”, mentioned Lance Alstodt, the Firm’s CEO. “The caliber of clinics which were chosen represents among the finest backbone care services within the nation as this choice course of represents a significant milestone for BioRestorative. We consider that an intradiscal injection of BRTX-100 has the potential to rework the remedy paradigm for sufferers affected by power lumbar disc illness.”
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 remedy 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 can be used for the non-surgical remedy 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 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 remedy is meant for sufferers whose ache has not been alleviated by non-invasive procedures and who doubtlessly face the prospect of surgical procedure. We’ve acquired authorization from the Food and Drug Administration to begin a Section 2 scientific trial utilizing BRTX-100 to deal with power 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 chargeable for extra caloric burning in addition to decreased glucose and lipid ranges. Researchers have discovered that folks with greater ranges of brown fats might have a decreased threat for weight problems and diabetes.
This press launch incorporates “forward-looking statements” inside 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 might be 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 because of numerous elements and different dangers, together with, with out limitation, these set forth within the Firm’s newest Kind 10-Okay filed with the Securities and Alternate Fee. 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.