Muscle cells grown in lab to be injected into bedridden patients
NCT ID NCT07426068
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This very early trial will test whether injecting a patient's own lab-grown muscle cells under the skin is safe for people with muscle atrophy from long-term bed rest. Only 6 participants will receive the transplant and be closely monitored for side effects and signs of muscle regrowth. The main goal is safety, not yet proof of effectiveness.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- lab-grown muscle cells (autologous differentiated myocytes)
- What this could lead to
- If safe, this could point toward a new way to rebuild lost muscle in people who are bedridden or have muscle-wasting diseases.
- What could go wrong
- This is an extremely early safety trial with only 6 people. It is not designed to prove the treatment works, and the cells may not survive or integrate well.
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.
- Phase
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Early phase 1
The earliest testing in people: a first look at safety, in a very small group.
- Participants
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About 6 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Feb 2028
An estimate. End dates often move.
- Lead sponsor
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A research network
The lead sponsor is a research network or cooperative group.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide 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.
Inclusion Criteria: 1. History of long-term bed rest: continuous bed rest for ≥4 weeks, with causes including neurological injury (such as brain death, stroke, or spinal cord injury), recovery after major orthopedic surgery, intensive care unit stay, or activity limitation due to chronic diseases. 2. Evidence of muscle atrophy: a significant reduction in muscle mass or muscle strength confirmed by clinical assessment and imaging. According to dual-energy X-ray absorptiometry (DXA), appendicular skeletal muscle mass index (ASM/height²) \< 7.0 kg/m² in men and \< 5.4 kg/m² in women, in accordance with EWGSOP2 criteria. 3. Stable underlying medical conditions, with no acute exacerbation, and an APACHE II score of 0-20. 4. Absence of severe comorbidities that would contraindicate surgical or transplantation interventions. 5. Written informed consent obtained from the patient, an immediate family member, or a legal guardian, agreeing to muscle biopsy, with general health status adequate to permit subcutaneous transplantation. Exclusion Criteria: 1. History of malignant tumors. 2. Coagulation disorders or current use of anticoagulant therapy. 3. Active infection or immunodeficiency. 4. Severe cardiac or renal insufficiency (estimated glomerular filtration rate \< 60 mL/min/1.73 m²; New York Heart Association \[NYHA\] class III-IV heart failure). 5. Muscle-related diseases, including hereditary myopathies (such as muscular dystrophy) or acquired myositis (creatine kinase \> 3 times the upper limit of normal). 6. Severe local skin lesions or a history of allergic reactions at the injection site. 7. Use of muscle growth-modulating medications (such as testosterone or growth hormone) within the past 6 months. 8. Long-term use of corticosteroids or immunosuppressive therapy, including anti-rejection medications following organ transplantation. 9. Other exclusion criteria: participation in other interventional clinical trials (excluding observational studies). 10. Any other medical or ethical conditions deemed by the investigator to make the participant unsuitable for enrollment.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
2 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital
Yancheng, Jiangsu, China
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National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital
Beijing, China
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