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Desperate patients get early access to experimental muscle cell therapy

NCT ID NCT04661293

Disease control Sponsor: Cook MyoSite Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused) This study
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This program offers expanded access to an experimental treatment using a patient's own muscle cells. It is for people with serious or life-threatening conditions who have no other options. Doctors can request the treatment for eligible patients, but it is not yet proven to work.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous muscle derived cells (AMDCs)
What this could lead to
If successful, this program could provide a treatment option for patients with serious muscle-related diseases who have no other alternatives.
What could go wrong
This is an early expanded access program, not a full clinical trial. The treatment is still investigational, and benefits are not guaranteed. Risks are not fully known.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

Children (under 18), adults (18 to 64) and older adults (65 and over)

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Cook MyoSite, Inc.

    Pittsburgh, Pennsylvania, 15238, United States