Status:
AVAILABLE
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Lead Sponsor:
Creative Medical Technology Holdings Inc
Conditions:
Chronic Back Pain
Degenerative Disc Disease Lumbar
Eligibility:
All Genders
18-80 years
Brief Summary
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.
Detailed Description
Expanded Access to CELZ-201-DDT (Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells) is available for individual patients with serious or life-threatening chronic lower ba...
Eligibility Criteria
Inclusion
- Confirmed diagnosis of chronic lower back pain due to degenerative disc disease.
- No comparable or satisfactory alternative therapy available. Unable to participate in the ongoing CELZ-201-DDT clinical trial. Informed consent provided.
Exclusion
- Any medical condition that poses an unacceptable risk or would interfere with treatment safety or evaluation.
- Known hypersensitivity to any component of the investigational product.
- How to Request Access:
- Contact the Expanded Access Coordinator to confirm eligibility and discuss feasibility.
- Complete and submit FDA Form 3926 to the appropriate FDA review division.
- Obtain IRB review (may be expedited or post-treatment for emergency use). Coordinate drug shipment and treatment schedule.
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT07137559
Last Update
August 22 2025
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