FDA Grants Fast Track Designation to CELZ-201-DDT for Degenerative Disc Disease Treatment

Creative Medical Technology Holdings has received Fast Track designation from the FDA for its lead therapy, CELZ-201-DDT, to treat degenerative disc disease. This designation enables accelerated FDA interactions and potential priority review, potentially expediting market access. CELZ-201-DDT is an allogeneic perinatal cell therapy within the company's AlloStem platform, aimed at addressing chronic lower back pain and disability.

Creative Medical Technology Holdings (NASDAQ: CELZ) has received FDA Fast Track designation for its lead therapy, CELZ-201-DDT, aimed at treating degenerative disc disease (DDD) and chronic lower back pain. This designation accelerates the FDA review process, potentially expediting market access for the therapy.

CELZ-201-DDT, part of the company's AlloStem® platform, is an allogeneic perinatal cell therapy administered via minimally invasive intramuscular injections. The therapy targets the underlying cellular degeneration in disc disease, offering a potentially transformative approach to managing chronic back pain. The global spinal disorders treatment market is projected to exceed $20 billion by 2030, highlighting the significant commercial potential for novel, effective therapies [1].

The FDA's Fast Track designation brings several tangible benefits to the development program, including more frequent interactions with FDA reviewers, eligibility for rolling BLA submissions, and potential priority review, which can reduce approval timelines from 10 months to 6 months. This designation is granted to therapies that address serious conditions with high unmet medical needs, validating CELZ-201-DDT's potential to fill a significant gap in the current treatment landscape.

The company's mention of an expanded access policy suggests they are preparing pathways for patients with serious conditions to access the treatment outside of clinical trials. This aligns with regulatory expectations for promising therapies addressing significant unmet needs. Creative Medical Technology is a clinical-stage biotechnology company focused on regenerative and immune cellular therapies, leveraging proprietary regenerative platforms and a robust regulatory strategy to accelerate development [2].

Addressing a large and growing market, DDD impacts millions of patients globally, with current options often limited to symptom management or invasive surgery. CELZ-201-DDT aims to restore function and improve quality of life by targeting the underlying cellular degeneration and inflammation. The company's strategic plans include the publication of an expanded access policy for CELZ-201-DDT within 15 days of this announcement.

References:
[1] https://www.stocktitan.net/news/CELZ/creative-medical-technology-holdings-secures-fda-fast-track-u32roz29iht2.html
[2] https://www.globenewswire.com/news-release/2025/08/13/2301892/EN/Creative-Medical-Technology-Holdings-Inc-Receives-FDA-Fast-Track-Designation-for-CELZ-201-DDT.html