An Early Phase 1 interventional study of Autologous differentiated myocyte transplantation in Metabolic Disease and Amyotrophy, sponsored by National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China. Not yet recruiting at 2 sites in China. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China · Early Phase 1, Interventional, and Treatment
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
For patients with muscle atrophy caused by multiple conditions leading to long-term bed rest, there is currently a lack of effective clinical strategies that can reverse or delay muscle atrophy and functional decline. Conventional rehabilitation training and nutritional support show limited benefit for muscle atrophy induced by prolonged immobilization, and new interventions are urgently needed. Based on our prior experimental findings, we have developed an autologous differentiated myocyte subcutaneous transplantation technique. This approach allows long-term survival of the graft in vivo, mimics a state of "continuous exercise," and provides stable secretion of myokines. Through these mechanisms, it systemically improves muscle quality, bone mineral density, energy metabolism, and inflammatory status.
This study aims to innovatively translate autologous differentiated myocyte subcutaneous transplantation to human application, with the goal of constructing a sustainable, spontaneously contractile, and endocrine-functional "muscle graft." The study objectives are as follows: (1) to verify graft survival, vascularization, and immune tolerance after autologous differentiated myocyte subcutaneous transplantation in patients with long-term bed rest-related muscle atrophy, and to ensure the safety of clinical application; (2) to systematically evaluate the effects of the graft on skeletal muscle mass, muscle strength, and exercise endurance, and to explore its potential to reverse muscle atrophy and preserve muscle function; and (3) to analyze the regulatory effects of graft-derived myokines on systemic energy metabolism, bone mineral density, and chronic inflammatory status, and to assess their impact on aging-related degenerative changes, including sarcopenia, osteoporosis, and metabolic disorders.
997 studies on the registry are indexed under Metabolic Diseases; 234 are open to participants now.
This study's planned enrollment of 6 is below the median of 48 across 670 interventional studies indexed under Metabolic Diseases.
Browse Metabolic Diseases studies →This is the only study on the registry with National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China as lead sponsor.
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Exclusion Criteria:
Each participant will complete the same set of assessments both before and after the intervention. A within-subject pre-post comparison will be performed to evaluate individualized responses and temporal changes induced by the subcutaneous muscle graft intervention.
Biological: 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.
Blood pressure
Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).
Time frame: Perioperative
Heart rate
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.
Time frame: Perioperative
Respiratory rate
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.
Time frame: Perioperative
Body temperature
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.
Time frame: Perioperative
Local adverse reactions
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.
Time frame: through study completion, an average of 1 year
Graft Volume
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.
Time frame: through study completion, an average of 1 year
Graft Morphology
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.
Time frame: through study completion, an average of 1 year
Graft Necrosis or Fluid Accumulation
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.
Time frame: through study completion, an average of 1 year
Graft Blood Perfusion
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.
Time frame: through study completion, an average of 1 year
Total White Blood Cell Count
Peripheral blood total white blood cell count measured during follow-up. Reported in ×10⁹/L as a single outcome measure.
Time frame: through study completion, an average of 1 year
Leukocyte Differential Percentages
Peripheral blood leukocyte differential, including neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages. Each subtype will be reported in percent (%) as separate outcome measures.
Time frame: through study completion, an average of 1 year
Neutrophil-to-Lymphocyte Ratio
Calculated from absolute neutrophil and lymphocyte counts. Reported as a unitless ratio (NLR) as a single outcome measure.
Time frame: through study completion, an average of 1 year
Pro-inflammatory Cytokines
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.
Time frame: through study completion, an average of 1 year
C-reactive Protein
Serum C-reactive protein concentration measured during follow-up. Reported in milligrams per liter (mg/L) as a single outcome measure.
Time frame: through study completion, an average of 1 year
Anti-inflammatory Cytokine IL-10
Serum IL-10 quantified by ELISA during follow-up. Reported in picograms per milliliter (pg/mL) as a single outcome measure.
Time frame: through study completion, an average of 1 year
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Plan to share: No — Individual participant data will not be shared at this stage.
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