NCT04661293

Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

• Status: Temporarily Not Available
• Phase: —
• Study type: Expanded Access
• Enrollment: —
• Sponsor: Cook MyoSite · Industry
• Sex: —
• Age: —
• Healthy volunteers: —

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 [e-mail].

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. Participation in our clinical trials is the first and most preferable route to access our investigational product. We understand that there may be patients with a serious, life-threatening disease or condition that have explored all other treatment options and are unable or ineligible to participate in our clinical trials. Expanded access, otherwise known as "compassionate use" or "pre-approval access," is a potential pathway to access an investigational product that a patient may otherwise be unable to receive. Cook MyoSite will consider providing an investigational product to a qualified requesting physician currently licensed within the United States via the United States Food and Drug Administration's (FDA's) expanded access pathway outside of an active clinical trial when eligibility criteria are met.

Interventions

Type	Name	Description
BIOLOGICAL	Autologous Muscle Derived Cells (AMDCs)

Timeline

• First posted: 2020-12-10
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States