Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) announced that it has finished enrolling patients in its FDA‑cleared ADAPT Phase III trial for CELZ‑201, also known as Olastrocel, a perinatal‑tissue‑derived cell therapy for chronic lower back pain.
The ADAPT study is a randomized, double‑blind, placebo‑controlled, dose‑escalation trial that evaluates safety, tolerability and preliminary efficacy of Olastrocel delivered via ultrasound‑guided intramuscular injection. The trial’s FDA clearance and Fast Track designation, coupled with the World Health Organization’s approval of the International Non‑Proprietary Name “olastrocel,” position the therapy on a clear regulatory path toward potential approval for degenerative disc disease.
Olastrocel targets a market of more than 16 million Americans suffering from chronic lower back pain, a condition that currently has limited durable, non‑surgical options. The therapy’s all‑off‑the‑shelf, allogeneic design promises scalability and consistency, and the company’s StemSpine® intellectual property portfolio strengthens its competitive position in orthopedics and beyond.
CEO Timothy Warbington said the enrollment milestone is a “defining moment” that validates the company’s execution capabilities and underscores the excitement surrounding CELZ‑201 among clinicians and patients. He added that the data will “fundamentally change how chronic lower back pain is treated—without surgery and without lifelong opioid dependence.”
The announcement was met with a positive market reaction, with the company’s market value increasing by roughly $245 million. Analyst sentiment is mixed, with some expressing optimism about the therapy’s potential while others remain cautious about the path to commercialization.
The next phase of the ADAPT trial will focus on follow‑up visits and data analysis. Successful completion of enrollment positions Creative Medical to generate compelling efficacy data, pursue regulatory submission, and ultimately bring a novel, non‑surgical treatment to patients and shareholders.
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