Status:
AVAILABLE
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
Lead Sponsor:
Cook MyoSite
Brief Summary
This is an expanded access program (EAP) for eligible participants designed to provide access to autologous muscle derived cells (AMDCs). Treating physicians may submit requests for expanded access to...
Detailed Description
Cook MyoSite, Inc. (Cook MyoSite) is committed to conducting rigorous, controlled clinical trials with variable inclusion and exclusion criteria based upon the indicated use under investigation. Parti...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- The patient has a serious or life-threatening disease or condition with no satisfactory alternative.
- Positive assessment that the anticipated benefits outweigh the risks to the patient.
- Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product.
- A determination that expanded access will not interfere with Cook MyoSite's ability to complete clinical trials in a timely fashion or which might otherwise delay marketing approval and ultimately availability to all patients.
- The patient can undergo a muscle biopsy procedure(s).
- The patient can undergo Cook MyoSite's required donor screening and testing.
Exclusion
Key Trial Info
Start Date :
Trial Type :
EXPANDED_ACCESS
End Date :
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04661293
Last Update
February 11 2025
Active Locations (1)
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1
Cook MyoSite, Inc.
Pittsburgh, Pennsylvania, United States, 15238