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

NCT07137559 | Unknown

• 2 other identifiers: ADAPT Expanded AccessNCT 06053242
• Study Type: expanded_access
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Back Pain; Degenerative Disc Disease Lumbar

Keywords

CELZ-201-DDT; Allogeneic Umbilical Cord Sub-Epithelial Cell-Derived Mesenchymal Stromal Cells; Mesenchymal Stromal Cells (MSC); Chronic Lower Back Pain; Degenerative Disc Disease (DDD); Lumbar Degeneration; Chronic Pain; Expanded Access; Single Patient IND; Emergency Use IND; Non-Emergency Use IND; Compassionate Use; Regenerative Medicine; Stem Cell Therapy

Interventions

CELZ-201-DDT DRUG

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Creative Medical Technology Holdings Inc: lead

MeSH Terms

Conditions

Intervertebral Disc Degeneration; Chronic Pain

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Creative Medical Technology

CONTACT

(702) 588-1890; expandedaccess@creativemedicaltechnology.com

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2025
• First Posted: August 22, 2025
• Last Updated: August 22, 2025

Record last verified: 2025-08