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.
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By
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Kathryn Wighton
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June 22, 2026
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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
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