BioRestorative Therapies Inc. (NASDAQ:BRTX) has received a unanimous recommendation to proceed in its Phase 2 clinical trial for chronic lumbar disc disease, BRTX-100. The independent review body Data Safety Monitoring Board (DSMB) which is overseeing dose and safety related issues during the course of the  trial approved the trial’s continuation with no changes to the current version of the protocol. 

This is the highest distinction given by the DSMB, which can recommend continuation without changes to the protocol, continuation with changes, or a suspension or termination of the trial. BioRestorative received unanimous approval from the DSMB to continue with no changes.

The safety data reviewed by the DSMB to determine if there was any toxicity related to dosing was taken from three patients who received BRTX-100, an injection of 40,000,000 hypoxic cultured mesenchymal stem cells formulated with autologous platelet lysate, while a fourth received an injection of saline placebo. There were no severe adverse events that were correlated to dose limiting toxicity (DLTs). The blinded results showed some of the patients experienced a reduction of pain and an increase in function.

The company plans to advance the expansion of the platform by leveraging the safety and efficacy data from BRTX-100s trials, as well as assisting KOLs in investigator-initiated studies and small-subject studies. It will be looking at the treatment’s potential indications in other avascular zones (areas in the body with little blood flow).  The cervical area and the meniscus, as well as the hips, the shoulders and the extremities could be potential areas of focus.  

Other companies involved in developing innovative cell therapies include Atherys, Inc. (NASDAQ:ATHX), Brainstorm Therapeutics (NASDAQ:BCLI), and Mesoblast (NASDAQ:MESO).