Creative Medical Technology Holdings (CELZ) announced positive interim data from its Phase 1/2 trial of StemSpine using AlloStem (CELZ-201-DDT), a donor cell therapy for chronic lower back pain due to degenerative disc disease (DDD). The FDA cleared an expanded dose escalation for the trial following statistically significant pain reduction and mobility improvement in participants. The ongoing trial, which is the first of its kind, uses a minimally invasive, ultrasound-guided injection of CELZ-201-DDT in an outpatient setting.
This development is potentially groundbreaking for patients suffering from chronic lower back pain, a widespread condition often treated with opioids or invasive surgery. The positive interim results, including statistically significant improvements in pain and mobility, suggest that CELZ-201-DDT could offer a much-needed non-opioid, minimally invasive alternative. The strong safety profile demonstrated thus far, with no serious adverse events reported, further strengthens the therapy’s potential to become a standard of care. This progress also validates the outpatient, ultrasound-guided injection approach, making it accessible to a broader patient population.
The trial utilizes a 4:1 treatment-to-placebo ratio and has reached its halfway point. Importantly, no dose-limiting toxicities or serious adverse events have been observed. The FDA’s clearance for dose expansion allows CELZ to optimize the therapy and potentially enhance its effectiveness. The Data Safety Monitoring Board (DSMB) and Institutional Review Board (IRB) have approved this new dosing strategy, which has already been implemented.
The positive interim data and FDA clearance for dose escalation bode well for CELZ and the future of chronic lower back pain treatment. If the positive trend continues in the second half of the trial, it could accelerate the path towards a pivotal Phase 3 trial and a subsequent Biologics License Application (BLA) submission to the FDA. This could ultimately lead to a paradigm shift in how chronic lower back pain is managed, offering patients a safer and more effective alternative to current treatments.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
