Metabolic DiseaseEarly Phase 1NCT07426068
Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation
A Early Phase 1 study testing Autologous differentiated myocyte transplantation in people with Metabolic Disease and Amyotrophy, run by National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China at 2 sites in China.
Trial summary
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Metabolic Disease, Amyotrophy
- What is being tested?
- Autologous differentiated myocyte transplantation
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2026to 1 Feb 2028
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
Show all 10Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital
Beijing
Honglin Xiang, +8618482610634, xianghonglin98@gmail.com
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital
Yancheng, Jiangsu
Liming Yang, +8617705115588, 17705115588@163.com
About this study
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
Read the detailed description
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.
- Conditions
- Metabolic Disease, Amyotrophy
- Being tested
- Autologous differentiated myocyte transplantation
- Keywords
- Autologous myocyte transplantation, muscle atrophy, Muscle endocrine function
- Medical subject headings
- Metabolic Diseases, Muscular Atrophy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous differentiated myocyte transplantationBiological
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 group | Role | What they receive |
|---|---|---|
| Autologous differentiated myocyte transplantation | Experimental | 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. Receives: Biological: Autologous differentiated myocyte transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood pressure
Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Feb 2026
- Study start1 Jul 2026 (estimated)
- Primary completion1 Feb 2028 (estimated)
- Study completion1 Feb 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China
- Sponsor type
- Research network
- Collaborators
- National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital, National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital
- Responsible party
- Sponsor
- Investigators
- Pengbin YIn, Principal investigator, National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07426068
- Sponsor's protocol ID
- 202602
- Status last verified
- Feb 2026
- First submitted
- 8 Feb 2026
- Last updated
- 23 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared at this stage.
Study at a glance
From the registry record, last updated by the sponsor on 23 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation
- ClinicalTrials.gov ID
- NCT07426068
- Acronym / sponsor ID
- 202602
- Conditions
- Metabolic Disease, Amyotrophy
- Keywords
- Autologous myocyte transplantation, muscle atrophy, Muscle endocrine function
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, ChinaResearch network
- Collaborators
- National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital, National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital
- Study start
- 1 Jul 2026 (estimated)
- Primary completion
- 1 Feb 2028 (estimated)
- Study completion
- 1 Feb 2028 (estimated)
- First posted
- 23 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Autologous differentiated myocyte transplantation | Experimental | Biological: Autologous differentiated myocyte transplantationEach 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Autologous differentiated myocyte transplantationAutologous 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. | Biological | Autologous differentiated myocyte transplantation |
Primary outcome
Blood pressure
Time frame: Perioperative
Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).
Heart rate
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Feb 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared at this stage.
Related trials for Metabolic Disease
Not yet recruitingPhase 3
Efficacy and Safety of Once-Weekly SHR-3167 Compared With Once-Daily Insulin Glargine in Adults With Insulin-Naive Type 2 Diabetes
Type 2 Diabetes
Recruiting
Effects of Lean Pork Loin Intake on Protein Homeostasis and Glucose Regulation in Prediabetic Adults
Hyperglycaemia (Non Diabetic), Prediabetes
Active, not recruiting
Shockwave™ vs Surgical Endarterectomy for Calcified Severe Common Femoral Artery Stenosis: Comparison of Efficacy, Safety and Long-Term Outcomes
Common Femoral Artery Stenosis, Calcification; Heart
RecruitingObservational study
Endoscopic Sleeve Gastroplasty (ESG) Prospective Trial for Obesity (EGO-Trial)
Obesity
Not yet recruitingObservational study
Periodontal Status and Biomarkers in MASLD
Metabolic Dysfunction-Associated Steatotic Liver Disease (MASLD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Pengbin YIn principal investigator
National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Autologous differentiated myocyte transplantation in people with Metabolic Disease and Amyotrophy, run by National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China at 2 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 23 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Honglin Xiang (+8618482610634, xianghonglin98@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood pressure (time frame: Perioperative). The study lists 15 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Feb 2026.