Patient Resources
What is Expanded Access?
What is Expanded Access?
Expanded Access (sometimes called “compassionate use”) is a regulatory pathway that may allow patients with serious or life-threatening conditions to receive an investigational treatment that has not yet been approved by the U.S. Food and Drug Administration (FDA).
Expanded Access is only available when:
- No comparable or satisfactory treatment options are available;
- The patient cannot participate in a clinical trial; and
- The potential benefit is considered to outweigh the potential risks.
Expanded Access must be requested by your treating physician and must be authorized by the FDA.
What is CELZ-201-DDT?
CELZ-201-DDT is an investigational (experimental) cell therapy currently being studied for individuals with degenerative disc disease (DDD) who experience chronic lower back pain.
CELZ-201-DDT is not approved by the FDA or any other health authority. Its safety and effectiveness have not been fully established.
Can I Receive CELZ-201-DDT Outside a Clinical Trial?
Possibly. If you have chronic lower back pain due to degenerative disc disease and are unable to participate in an ongoing clinical trial, your physician may request Expanded Access on your behalf.
Expanded Access may be considered if:
- No other treatments are appropriate or effective for you;
- You are not eligible for a CELZ-201-DDT clinical trial;
- Sufficient product is available;
- The potential benefits are judged to outweigh the potential risks; and
- FDA and ethics board approvals are obtained.
Expanded Access is reviewed on a case-by-case basis and is not guaranteed.
How does my doctor ask for Expanded Access?
Only a licensed treating physician may submit a request.
Your physician may contact Creative Medical Technology Holdings, Inc. (CMTH) at:
Email: expandedaccess@creativemedicaltechnology.com
Mail: 211 E. Osborn Road, Phoenix, AZ 85012
Attn: Expanded Access Program Coordinator
Your physician must:
- Submit the appropriate request to the FDA (FDA Form 3926 for individual patients);
- Obtain approval from an Institutional Review Board (IRB);
- Obtain your written informed consent; and
- Coordinate treatment and safety monitoring with the sponsor.
Will I Automatically Receive the Therapy if My Doctor Requests it?
No. Each request is carefully evaluated. Approval depends on your medical condition, regulatory authorization, product availability, and sponsor review. Expanded Access is not guaranteed.
Are There Costs Associated with Expanded Access?
The investigational product is generally provided without charge; however, there may be costs related to administering the treatment (such as hospital, clinic, laboratory, or physician fees). These costs may not be covered by insurance. Patients should discuss potential financial responsibilities with their healthcare provider.
Where can I Find More Information?
You can review publicly available study information at:
For general information about Expanded Access, you may visit the FDA website at:
https://www.fda.gov/news-events/expanded-access/expanded-access-information-industry
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