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Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)

Studies

Study First Submitted Date 2020-12-03
Study First Posted Date 2020-12-10
Last Update Posted Date 2023-01-10
Verification Month Year January 2023
Verification Date 2023-01-31
Last Update Posted Date 2023-01-10

Detailed Descriptions

Sequence: 20814493
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.

Facilities

Sequence: 200881459
Status Available
Name Cook MyoSite, Inc.
City Pittsburgh
State Pennsylvania
Zip 15238
Country United States

Id Information

Sequence: 40326041
Id Source org_study_id
Id Value AMDC-EAP

Countries

Sequence: 42749154
Name United States
Removed False

Interventions

Sequence: 52716143
Intervention Type Biological
Name Autologous Muscle Derived Cells (AMDCs)

Sponsors

Sequence: 48539640
Agency Class INDUSTRY
Lead Or Collaborator lead
Name Cook MyoSite

Central Contacts

Sequence: 12071139
Contact Type primary
Name Cook MyoSite
Phone 412-963-7380
Email MYO-ExpandedAccess@CookMyoSite.com
Role Contact

Eligibilities

Sequence: 30901694
Minimum Age N/A
Maximum Age N/A
Criteria 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.
Adult True
Child True
Older Adult True

Calculated Values

Sequence: 254155195
Number Of Facilities 1
Registered In Calendar Year 2020
Were Results Reported False
Has Us Facility True
Has Single Facility True

Links

Sequence: 4405619 Sequence: 4405620
Url https://resources.cookmyosite.com/terms-and-conditions-of-sale-and-delivery-0 Url https://www.cookmyosite.com/
Description Cook MyoSite, Inc. Expanded Access Webpage Description Cook MyoSite, Inc. Webpage

Responsible Parties

Sequence: 29014051
Responsible Party Type Sponsor