Clinical Trials in China / NCT07426068
Starting soon
Early Phase 1
Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation
NCT07426068 · tracked via the Priya Life Science China tracker
Condition(s) studied
Metabolic DiseaseAmyotrophy
Investigational drug(s) / intervention(s)
Autologous differentiated myocyte transplantation
Autologous differentiated myocyte transplantation: Autologous differentiated myocytes will be prepared from each participant and transplanted subcutaneously. All enrolled participants will receive the same intervention and will be followed longitudinally for safety, feasibility, and outcome assessments.
Study summary
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
Eligibility
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.
Primary outcome measure(s)
- Blood pressure — Perioperative
Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg). - Heart rate — Perioperative
Use electrocardiographic monitoring to assess heart rate during the perioperative period. Heart rate will be reported in beats per minute (bpm) as a single outcome measure. - Respiratory rate — Perioperative
Use electrocardiographic monitoring to assess respiratory rate during the perioperative period. Respiratory rate will be reported in breaths per minute (breaths/min) as a single outcome measure. - Body temperature — Perioperative
Use continuous temperature monitoring to assess body temperature during the perioperative period. Body temperature will be reported in degrees Celsius (°C) as a single outcome measure. - Local adverse reactions — through study completion, an average of 1 year
Perform visual inspection to assess local reactions during the perioperative period, including redness, swelling, induration, and signs of infection. Local reactions will be recorded as categorical outcomes (present/absent for each sign) as separate outcome measures. - Graft Volume — through study completion, an average of 1 year
Gross visual assessment of changes in graft volume during follow-up. Graft volume will be reported in cubic centimeters (cm³) as a single outcome measure. - Graft Morphology — through study completion, an average of 1 year
Ultrasonographic evaluation of graft morphology and echo uniformity during follow-up. Morphologic features will be recorded as categorical outcomes (normal/abnormal echo pattern) as a single outcome measure. - Graft Necrosis or Fluid Accumulation — through study completion, an average of 1 year
Ultrasonographic detection of necrosis or fluid accumulation within the graft during follow-up. Findings will be recorded as categorical outcomes (present/absent for each feature) as separate outcome measures. - Graft Blood Perfusion — through study completion, an average of 1 year
Assessment of graft blood perfusion to determine the extent of vascular regeneration during follow-up. Perfusion will be quantified using Doppler perfusion indices (e.g., vascularity score or perfusion index) as a single outcome measure. - Total White Blood Cell Count — through study completion, an average of 1 year
Peripheral blood total white blood cell count measured during follow-up. Reported in ×10⁹/L as a single outcome measure. - Leukocyte Differential Percentages — through study completion, an average of 1 year
Peripheral blood leukocyte differential, including neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages. Each subtype will be reported in percent (%) as separate outcome measures. - Neutrophil-to-Lymphocyte Ratio — through study completion, an average of 1 year
Calculated from absolute neutrophil and lymphocyte counts. Reported as a unitless ratio (NLR) as a single outcome measure. - Pro-inflammatory Cytokines — through study completion, an average of 1 year
Serum IL-6, TNF-α, IFN-γ, and IL-1β quantified by ELISA during follow-up. Each cytokine will be reported in picograms per milliliter (pg/mL) as separate outcome measures. - C-reactive Protein — through study completion, an average of 1 year
Serum C-reactive protein concentration measured during follow-up. Reported in milligrams per liter (mg/L) as a single outcome measure. - Anti-inflammatory Cytokine IL-10 — through study completion, an average of 1 year
Serum IL-10 quantified by ELISA during follow-up. Reported in picograms per milliliter (pg/mL) as a single outcome measure.
Trial sites (2)
| Facility | City | Region | Status |
|---|---|---|---|
| National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital | Yancheng | Jiangsu | |
| National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital | Beijing | China |
Other trials for the same condition
Official registry record
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07426068 on ClinicalTrials.gov ↗ ← All trials in China