Biorestorative Therapies, Inc. ((BRTX)) announced an update on their ongoing clinical study.
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BioRestorative Therapies, Inc. is conducting a clinical study titled ‘A Phase 2, Double-Blind, Controlled, Randomized Study to Evaluate the Safety and Preliminary Efficacy of a Single Dose Intradiscal Injection of BRTX-100 for Patients With Chronic Lumbar Disc Disease (cLDD).’ The study aims to assess the safety and initial effectiveness of BRTX-100, a treatment for chronic lumbar disc disease, a condition characterized by persistent back pain due to disc degeneration. This study is significant as it explores a potential new treatment option for patients suffering from this debilitating condition.
The intervention being tested is BRTX-100, which is a biological treatment consisting of hypoxic-cultured bone marrow mononuclear cells enriched with mesenchymal stem cells from the patient’s own bone marrow, combined with autologous platelet lysate. The purpose of this intervention is to provide a regenerative treatment for chronic lumbar disc disease.
The study is designed as a randomized, double-blind, controlled trial with a parallel intervention model. Participants are randomly assigned in a 2:1 ratio to receive either the BRTX-100 treatment or a sham comparator using isotonic saline. The primary goal of the study is treatment-focused, with both participants and investigators blinded to the treatment allocation.
The study began on July 31, 2019, and is currently recruiting participants. The latest update was submitted on August 20, 2025. These dates are crucial as they indicate the study’s progress and ongoing nature, providing a timeline for potential results and further developments.
The market implications of this study update could be significant for BioRestorative Therapies, Inc. Successful results may positively influence the company’s stock performance and attract investor interest, especially in the competitive field of regenerative medicine. Investors should monitor this study closely as it progresses.
The study is ongoing, with further details available on the ClinicalTrials portal.