About this trial
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
Eligibility criteria
Qualifiers
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.
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.
Stable underlying medical conditions, with no acute exacerbation, and an APACHE II score of 0-20.
Absence of severe comorbidities that would contraindicate surgical or transplantation interventions.
Disqualifiers
History of malignant tumors.
Coagulation disorders or current use of anticoagulant therapy.
Active infection or immunodeficiency.
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).
Trial design
Treatments tested in this trial
- Autologous differentiated myocyte transplantation
Treatment groups
Locations
2Sponsors and collaborators
National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China
Lead sponsor
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital
Collaborator
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital
Collaborator