Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

NCT04661293 | Unknown

• 1 other identifier: AMDC-EAP
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 1

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

Interventions

Autologous Muscle Derived Cells (AMDCs) BIOLOGICAL

Eligibility Criteria

• Sex: all
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Cook MyoSite: lead

Study Sites (1)

Cook MyoSite, Inc.

Pittsburgh, Pennsylvania, 15238, United States

Location

Related Links

• Cook MyoSite, Inc. Expanded Access Webpage
• Cook MyoSite, Inc. Webpage

Study Design

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

Study Record Dates

• First Submitted: December 3, 2020
• First Posted: December 10, 2020
• Last Updated: February 13, 2026

Record last verified: 2026-02

Locations

US (1)