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

August 14, 2025 updated by: Creative Medical Technology Holdings Inc

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

CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for people with degenerative disc disease who have chronic lower back pain.

Study Overview

Status

Available

Conditions

Intervention / Treatment

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.

Study Type

Expanded Access

Expanded Access Type

  • Individual Patients

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Creative Medical Technology Holdings Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted

August 14, 2025

First Submitted That Met QC Criteria

August 14, 2025

First Posted (Actual)

August 22, 2025

Study Record Updates

Last Update Posted (Actual)

August 22, 2025

Last Update Submitted That Met QC Criteria

August 14, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADAPT Expanded Access
  • NCT 06053242 (Other Identifier: clinicaltrials.gov)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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