Physician Resources
Patient Eligibility Criteria
A licensed treating physician may request Expanded Access for an individual patient under IND 029792 if all of the following criteria are met:
- The patient has a serious or life-threatening condition — specifically, chronic lower back pain due to degenerative disc disease (DDD).
- There is no comparable or satisfactory alternative therapy available.
- The patient is ineligible for, or unable to participate in, the ongoing CELZ-201-DDT clinical trial.
- The treating physician determines that the potential benefit justifies the potential risks.
- Provision of Expanded Access will not interfere with the ongoing clinical development program.
Expanded Access is not guaranteed. Authorization is subject to medical eligibility, regulatory approval, product availability, manufacturing capacity, and sponsor evaluation of the individual benefit–risk profile.
Process for Non-Emergency Requests
For non-emergency single-patient Expanded Access requests, the treating physician must:
- Contact the Expanded Access Coordinator at Creative Medical Technology Holdings, Inc.
- Submit FDA Form 3926 (Individual Patient Expanded Access IND) to the appropriate FDA review division.
- Obtain Institutional Review Board (IRB) review and approval in accordance with federal regulations.
- Obtain written informed consent from the patient.
- Coordinate product shipment, administration logistics, and safety monitoring with the sponsor following FDA authorization.
Emergency requests must follow FDA emergency IND procedures under 21 CFR 312.310.
Treatment Overview
CELZ-201-DDT is an investigational allogeneic umbilical cord–derived mesenchymal stem cell therapy administered via intramuscular injection.
Dosing, administration, and follow-up requirements will be determined by the treating physician in coordination with the sponsor and in accordance with FDA authorization. Appropriate safety monitoring will be conducted during and after treatment. All serious adverse events will be reported to the FDA and the IRB as required under 21 CFR Part 312.
Contact for Physicians
Expanded Access Coordinator
Creative Medical Technology Holdings, Inc.
Email: expandedaccess@creativemedicaltechnology.com
Phone: 702.588.1890
Additional Resources
- FDA Expanded Access Overview: https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry
- FDA Form 3926: https://www.fda.gov/media/98616/download
- ClinicalTrials.gov Expanded Access Record: Study Details | NCT07137559 | CELZ-201-DDT for the Treatment of Chronic Lower Back Pain | ClinicalTrials.gov
Disclaimer: Expanded Access use of CELZ-201-DDT has not been approved by the FDA for commercial distribution. CELZ-201-DDT remains an investigational therapy, and its safety and effectiveness have not been fully established.
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