- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04661293
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs) (AMDC)
Study Overview
Status
Intervention / Treatment
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.
Study Type
Expanded Access Type
- Individual Patients
Contacts and Locations
Study Contact
- Name: Cook MyoSite
- Phone Number: 412-963-7380
- Email: MYO-ExpandedAccess@CookMyoSite.com
Study Locations
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Pennsylvania
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Pittsburgh, Pennsylvania, United States, 15238
- Available
- Cook Myosite, Inc.
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- AMDC-EAP
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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