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

NCT ID: NCT07137559

Last Updated: 2025-08-22

Basic Information

• Recruitment Status: AVAILABLE
• Study Classification: EXPANDED_ACCESS

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.

Conditions

Chronic Back Pain; Degenerative Disc Disease Lumbar

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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 Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Creative Medical Technology Holdings Inc

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Creative Medical Technology

Role: CONTACT

expandedaccess@creativemedicaltechnology.com

(702) 588-1890

Other Identifiers

NCT 06053242

Identifier Type: OTHER

Identifier Source: secondary_id

ADAPT Expanded Access

Identifier Type: -

Identifier Source: org_study_id