Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

AMDC-EAP

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 Cook MyoSite's investigational product by email to MYO-ExpandedAccess@CookMyoSite.com.

-1

Eligibility Criteria: 1. The patient has a serious or life-threatening disease or condition with no satisfactory alternative. 2. Positive assessment that the anticipated benefits outweigh the risks to the patient. 3. Positive assessment that Cook MyoSite has an adequate supply of resources for producing the investigational product. 4. 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. 5. The patient can undergo a muscle biopsy procedure(s). 6. The patient can undergo Cook MyoSite's required donor screening and testing.

2024-02-09