FDA Approves BRTX-100 Phase 2 Trial Protocol Amendment

BioRestorative Therapies, Inc., a clinical-stage firm specializing in stem cell therapies, has received FDA approval for a significant change in the ongoing Phase 2 study of BRTX-100, the company’s primary cell therapy candidate for chronic lumbar disc disease (cLDD). The study's control group will now receive sham injections instead of saline injections, enhancing the safety for participants and reducing the risk of temporary clinical results that could affect the study's final conclusions.

The company's CEO, Lance Alstodt, emphasized that the FDA's approval of the amendment reflects a strong cooperative relationship and ensures that the control group's outcomes are not influenced by saline injections. He clarified that the new protocol will involve a needle placed near the target disc without piercing it or injecting saline, and this change will not alter the study's timeline, maintaining the target of completing enrollment in 2024.

BRTX-100 is a unique therapeutic product designed to treat areas with limited blood supply. It is being evaluated in a Phase 2 study involving up to 99 subjects across 16 U.S. clinical sites. The study is designed to be prospective, randomized, double-blinded, and controlled, with subjects receiving either BRTX-100 or a placebo in a 2:1 ratio.

BioRestorative Therapies is focused on developing therapeutic products using cell and tissue protocols, with a primary focus on adult stem cells. The company has two main programs: the Disc/Spine Program with BRTX-100, which is formulated from a patient's own bone marrow stem cells for non-surgical treatment of painful lumbosacral disc disorders, and the Metabolic Program with ThermoStem®, which aims to treat obesity and metabolic disorders using stem cells derived from brown adipose tissue to generate more brown adipose tissue, potentially reducing obesity and diabetes risks.

The company's Phase 2 clinical trial for BRTX-100 is underway to treat chronic lower back pain resulting from degenerative disc disease. Initial research suggests that increasing brown fat in animals can lead to additional calorie burning and improved metabolic regulation, indicating that higher levels of brown fat in humans may correlate with a reduced risk of obesity and diabetes.