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Expanded Access Program for Autologous Muscle Derived Cells (AMDCs) (AMDC)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04661293
Expanded Access Status : Available
First Posted : December 10, 2020
Last Update Posted : January 10, 2023
Sponsor:
Information provided by (Responsible Party):
Cook MyoSite

Study Description
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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.

Intervention/treatment
Biological: Autologous Muscle Derived Cells (AMDCs)

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 Design
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Study Type : Expanded Access
Expanded Access Type : Individual Patients
Official Title: Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

Resource links provided by the National Library of Medicine


Interventions
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Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   Child, Adult, Older Adult
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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04661293


Contacts
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Contact: Cook MyoSite 412-963-7380 MYO-ExpandedAccess@CookMyoSite.com

Locations
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United States, Pennsylvania
Cook MyoSite, Inc. Available
Pittsburgh, Pennsylvania, United States, 15238
Sponsors and Collaborators
Cook MyoSite
More Information
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Additional Information:

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Responsible Party: Cook MyoSite
ClinicalTrials.gov Identifier: NCT04661293    
Other Study ID Numbers: AMDC-EAP
First Posted: December 10, 2020    Key Record Dates
Last Update Posted: January 10, 2023
Last Verified: January 2023