FDA Clears Olastrocel Trial Expansion
Additional patients with ongoing opioid use are being enrolled as Creative Medical prepares for potential Phase 3 discussions with the FDA.
By
Kathryn Wighton
June 22, 2026
Clinical Scorecard: FDA Clears Olastrocel Trial Expansion
At a Glance
Category Detail
Condition Chronic lower back pain associated with degenerative disc disease Key Mechanisms Allogeneic, perinatal tissue-derived regenerative cell therapy Target Population Patients with chronic lower back pain and ongoing opioid use Care Setting Clinical trial
Key Highlights
FDA cleared expansion of ADAPT clinical trial for CELZ-201 (Olastrocel) New cohort enrolling 15 patients on less than 90 mg of morphine-equivalent opioids per day AI-based monitoring platform for real-time patient-reported outcomes Guideline-Based Recommendations
Diagnosis
Evaluate patients with chronic lower back pain and degenerative disc disease Management
Monitoring & Follow-up
Utilize AI-based platforms for tracking patient outcomes and analgesic use Risks
Monitor for adverse events during treatment Patient & Prescribing Data
Patients with chronic lower back pain and opioid use
Olastrocel administered via minimally invasive, ultrasound-guided intramuscular procedure
Clinical Best Practices
Engage in ongoing monitoring of patient-reported outcomes Ensure adherence to electronic diary for data collection Related Resources & Content
