Clinical trialAMDCNCT04661293
Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
A study testing Autologous Muscle Derived Cells (AMDCs), run by Cook MyoSite at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Autologous Muscle Derived Cells (AMDCs)
- How many people
- Not given
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Expanded access
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Child, Adult, Older adult
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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Being tested
- Autologous Muscle Derived Cells (AMDCs)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Muscle Derived Cells (AMDCs)Biological
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Expanded access
Sponsor and investigators
- Lead sponsor
- Cook MyoSite
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04661293
- Sponsor's protocol ID
- AMDC-EAP
- Acronym
- AMDC
- Status last verified
- Feb 2026
- First submitted
- 3 Dec 2020
- Last updated
- 13 Feb 2026
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expanded Access Program for Autologous Muscle Derived Cells (AMDCs)
- ClinicalTrials.gov ID
- NCT04661293
- Acronym / sponsor ID
- AMDC / AMDC-EAP
- Study type
- Expanded access
- Recruitment status
- Temporarily Not Available
- Lead sponsor
- Cook MyoSiteIndustry (pharma, biotech, devices)
- First posted
- 10 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
Who may qualify
- Age groups
- Child, Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous Muscle Derived Cells (AMDCs) | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Feb 2026.
- Cook MyoSite, Inc. Expanded Access WebpageLink provided by the sponsor.
- Cook MyoSite, Inc. WebpageLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Autologous Muscle Derived Cells (AMDCs), run by Cook MyoSite at 1 site in United States.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Feb 2026.