Creative Medical Technologies Holdings Inc. (CELZ) reported what it called a major clinical infection point after releasing positive interim 180-day data from its FDA-cleared ADAPT trial.
ADAPT is a phase I/II clinical trial evaluating CELZ-201, the company's proprietary perinatal tissue-derived cell therapy for the treatment of chronic lower back pain associated with degenerative disc disease.
The company said the therapy achieved statistically significant and clinically meaningful improvements in both functional disability and pain, supported by a strong safety profile.
In the ADAPT trial, there was a mean improvement of 15.3 percentage points in functional disability at 180 days, with approximately 79% of patients achieving clinically meaningful benefit. Pain scores declined by an average of 3.9 points on a 10-point scale, with a similar proportion of patients experiencing at least a two-point reduction.
An independent Data Safety Monitoring Board previously confirmed that CELZ-201 demonstrated a favorable safety profile with no significant adverse events, supporting continued advancement of the program. The trial remains blinded with a 4:1 treatment-to-placebo ratio.
The company described the results as a pivotal moment for the company, signaling a transition from early clinical execution to a phase focused on regulatory engagement and strategic value creation.CEO Timothy Warbington said the data reinforce CELZ-201's potential as a scalable, non-surgical, disease-modifying therapy for chronic lower back pain, a condition affecting more than 16 million Americans.
The company noted that the interim findings, combined with earlier safety reviews, position CELZ-201 for late-stage discussions with regulators and potential partners as it prepares for commercialisation planning.
Chronic lower back pain represents a multi-billion-dollar market where current treatment options often rely on opioids, steroid injections, or invasive spine surgery. Creative Medical said its off-the-shelf allogeneic cell therapy is designed to offer a durable, minimally invasive alternative.
The company expects to advance toward additional regulatory interactions and strategic partnership discussions as it awaits final ADAPT trial data.
CELZ has traded between $1.50 and $6.90 over the past year. The stock is currently trading at $1.93, down 5.49%.
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