Ignite Creation Date:
2025-12-24 @ 2:23 PM
Ignite Modification Date:
2026-01-02 @ 10:12 AM
Study NCT ID:
NCT07137559
Status:
AVAILABLE
Last Update Posted:
2025-08-22
First Post:
2025-08-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Sponsor:
Creative Medical Technology Holdings Inc
Organization:
Study Overview
Official Title:
Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain
Status:
AVAILABLE
Status Verified Date:
2025-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ADAPT
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 back pain due to degenerative disc disease (DDD) who have no comparable or satisfactory alternative therapy options.
Requests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).
For non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.
For emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.
Requests will be considered on a case-by-case basis under a single-patient IND in coordination with the U.S. Food and Drug Administration (FDA) and an Institutional Review Board (IRB).
For non-emergency requests, the treating physician must submit FDA Form 3926 and obtain FDA authorization before initiating treatment.
For emergency use, treatment may begin without prior FDA authorization if criteria for emergency use are met; the physician must notify the FDA within 5 working days after treatment.
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| NCT 06053242 | OTHER | clinicaltrials.gov | View |