Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6
- 试验地点
- 2
- 主要终点
- Total White Blood Cell Count
研究概览
简要总结
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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-
- •Absence of severe comorbidities that would contraindicate surgical or transplantation interventions.
- •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.
排除标准
- •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).
- •Muscle-related diseases, including hereditary myopathies (such as muscular dystrophy) or acquired myositis (creatine kinase > 3 times the upper limit of normal).
- •Severe local skin lesions or a history of allergic reactions at the injection site.
- •Use of muscle growth-modulating medications (such as testosterone or growth hormone) within the past 6 months.
- •Long-term use of corticosteroids or immunosuppressive therapy, including anti-rejection medications following organ transplantation.
- •Other exclusion criteria: participation in other interventional clinical trials (excluding observational studies).
- •Any other medical or ethical conditions deemed by the investigator to make the participant unsuitable for enrollment.
研究组 & 干预措施
Autologous differentiated myocyte transplantation
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.
干预措施: Autologous differentiated myocyte transplantation (Biological)
结局指标
主要结局
Total White Blood Cell Count
时间窗: 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.
Body temperature
时间窗: 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.
Blood pressure
时间窗: Perioperative
Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).
Heart rate
时间窗: 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
时间窗: 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.
Local adverse reactions
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
Leukocyte Differential Percentages
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点