Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 1:18 AM
Ignite Modification Date:
2025-12-25 @ 1:18 AM
NCT ID:
NCT04661293
Eligibility Criteria:
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.
Study:
NCT04661293
Study Brief:
Protocol Section:
NCT04661293