NCT07137559

CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

Expanded Access Intramuscular Injection of CELZ-201-DDT for the Treatment of Chronic Lower Back Pain

• Status: Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Creative Medical Technology Holdings Inc · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: —

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.

Conditions

• Chronic Back Pain
• Degenerative Disc Disease Lumbar

Interventions

Type	Name	Description
DRUG	CELZ-201-DDT	CELZ-201-DDT is administered via intramuscular injection. Dosing, administration, and follow-up will be determined by the treating physician in accordance with the EA authorization and medical judgment. Safety monitoring will be performed during and after treatment, and all serious adverse events will be reported to the FDA and IRB per applicable regulations.

Timeline

• First posted: 2025-08-22
• Last updated: 2025-08-22