Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-80
SponsorNational Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China

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

6 Participants
are divided into 1 treatment group

Locations

2
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital YanchengJiangsu, China
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital Beijing China

Sponsors 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