Ignite Creation Date:
2026-03-26 @ 3:15 PM
Ignite Modification Date:
2026-03-30 @ 2:15 AM
Study NCT ID:
NCT07426068
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-23
First Post:
2026-02-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009133', 'term': 'Muscular Atrophy'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2026-01-20', 'size': 383177, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2026-02-08T20:35', 'hasProtocol': True}, {'date': '2026-01-20', 'size': 260672, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2026-02-08T20:35', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Each participant will complete the same set of assessments both before and after the intervention. An within-subject pre-post comparison will be performed to evaluate individualized responses and temporal changes induced by the subcutaneous muscle graft intervention.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 6}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-15', 'studyFirstSubmitDate': '2026-02-08', 'studyFirstSubmitQcDate': '2026-02-15', 'lastUpdatePostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-02-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood pressure', 'timeFrame': 'Perioperative', 'description': 'Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).'}, {'measure': 'Heart rate', 'timeFrame': 'Perioperative', 'description': '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.'}, {'measure': 'Respiratory rate', 'timeFrame': 'Perioperative', 'description': '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.'}, {'measure': 'Body temperature', 'timeFrame': 'Perioperative', 'description': '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.'}, {'measure': 'Local adverse reactions', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Graft Volume', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Graft Morphology', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Graft Necrosis or Fluid Accumulation', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Graft Blood Perfusion', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'Total White Blood Cell Count', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Peripheral blood total white blood cell count measured during follow-up. Reported in ×10⁹/L as a single outcome measure.'}, {'measure': 'Leukocyte Differential Percentages', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Peripheral blood leukocyte differential, including neutrophil, lymphocyte, monocyte, eosinophil, and basophil percentages. Each subtype will be reported in percent (%) as separate outcome measures.'}, {'measure': 'Neutrophil-to-Lymphocyte Ratio', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Calculated from absolute neutrophil and lymphocyte counts. Reported as a unitless ratio (NLR) as a single outcome measure.'}, {'measure': 'Pro-inflammatory Cytokines', 'timeFrame': 'through study completion, an average of 1 year', 'description': '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.'}, {'measure': 'C-reactive Protein', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Serum C-reactive protein concentration measured during follow-up. Reported in milligrams per liter (mg/L) as a single outcome measure.'}, {'measure': 'Anti-inflammatory Cytokine IL-10', 'timeFrame': 'through study completion, an average of 1 year', 'description': 'Serum IL-10 quantified by ELISA during follow-up. Reported in picograms per milliliter (pg/mL) as a single outcome measure.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Autologous myocyte transplantation', 'muscle atrophy', 'Muscle endocrine function'], 'conditions': ['Metabolic Disease', 'Amyotrophy']}, 'descriptionModule': {'briefSummary': 'This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.', 'detailedDescription': '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.\n\nThis 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 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.\n2. 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.\n3. Stable underlying medical conditions, with no acute exacerbation, and an APACHE II score of 0-20.\n4. Absence of severe comorbidities that would contraindicate surgical or transplantation interventions.\n5. 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.\n\nExclusion Criteria:\n\n1. History of malignant tumors.\n2. Coagulation disorders or current use of anticoagulant therapy.\n3. Active infection or immunodeficiency.\n4. 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).\n5. Muscle-related diseases, including hereditary myopathies (such as muscular dystrophy) or acquired myositis (creatine kinase \\> 3 times the upper limit of normal).\n6. Severe local skin lesions or a history of allergic reactions at the injection site.\n7. Use of muscle growth-modulating medications (such as testosterone or growth hormone) within the past 6 months.\n8. Long-term use of corticosteroids or immunosuppressive therapy, including anti-rejection medications following organ transplantation.\n9. Other exclusion criteria: participation in other interventional clinical trials (excluding observational studies).\n10. Any other medical or ethical conditions deemed by the investigator to make the participant unsuitable for enrollment.'}, 'identificationModule': {'nctId': 'NCT07426068', 'briefTitle': 'Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation', 'organization': {'class': 'NETWORK', 'fullName': 'National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China'}, 'officialTitle': 'Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation', 'orgStudyIdInfo': {'id': '202602'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Autologous differentiated myocyte transplantation', 'description': '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.', 'interventionNames': ['Biological: Autologous differentiated myocyte transplantation']}], 'interventions': [{'name': 'Autologous differentiated myocyte transplantation', 'type': 'BIOLOGICAL', 'description': '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.', 'armGroupLabels': ['Autologous differentiated myocyte transplantation']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Yancheng', 'state': 'Jiangsu', 'country': 'China', 'contacts': [{'name': 'Liming Yang', 'role': 'CONTACT', 'email': '17705115588@163.com', 'phone': '+8617705115588'}], 'facility': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital', 'geoPoint': {'lat': 33.3575, 'lon': 120.1573}}, {'city': 'Beijing', 'country': 'China', 'contacts': [{'name': 'Honglin Xiang', 'role': 'CONTACT', 'email': 'xianghonglin98@gmail.com', 'phone': '+8618482610634'}], 'facility': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Honglin Xiang', 'role': 'CONTACT', 'email': 'xianghonglin98@gmail.com', 'phone': '+8618482610634'}], 'overallOfficials': [{'name': 'Pengbin YIn', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will not be shared at this stage.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China', 'class': 'NETWORK'}, 'collaborators': [{'name': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital', 'class': 'UNKNOWN'}, {'name': 'National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}