BioRestorative Therapies, a company focused on regenerative medicine, has marked a significant milestone with its product candidate BRTX-100 in the fight against chronic lower back pain. The firm completed a phase 2 clinical trial for chronic lumbar disc disease (cLDD), and CEO Lance Alstodt shared insights during a recent interview on Benzinga’s All-Access platform.
The results from the first 36 participants in the trial were promising. Alstodt reported that over 74% of individuals exhibited a greater than 50% improvement in functional ability, while more than 72% experienced a similar reduction in pain levels. These outcomes significantly surpassed the 30% percent improvement threshold established by the U.S. Food and Drug Administration (FDA). Alstodt emphasized that these results pave the way for a pivotal trial, which could expedite the approval process for BRTX-100.
Innovative Approach to Pain Management
BRTX-100 is an autologous stem cell therapy designed to address the underlying causes of chronic pain rather than merely alleviating symptoms, as is common with opioid medications and other injectable treatments. The therapy involves harvesting a patient’s stem cells, which are then cultured and injected directly into the affected disc to promote healing.
Alstodt highlighted the distinct nature of BRTX-100, asserting, “We are not just masking the pain. Our focus is on targeting the root cause.” This fundamental difference in approach could change the landscape of chronic pain treatment, offering hope to those suffering from debilitating conditions.
The phase 2 trial aims to enroll a total of 99 patients, with Alstodt indicating that recruitment is progressing well. An announcement regarding enrollment updates is expected in the near future.
Expansion and Future Prospects
In the Benzinga interview, Alstodt also discussed BioRestorative’s broader expansion plans and what lies ahead for the company. The potential for BRTX-100 reflects a growing trend in regenerative therapies that seek to utilize the body’s own resources for healing. As the company moves towards the next stages of development, the impact of these therapies on chronic pain management could be substantial.
With BRTX-100’s results setting a positive precedent, BioRestorative Therapies is poised to contribute significantly to the field of regenerative medicine, particularly for those grappling with chronic conditions. The ongoing developments will be closely watched by both the medical community and potential investors.
For those interested, the full interview with Lance Alstodt offers deeper insights into BioRestorative’s innovative strategies and future directions.
