NCT07426068

Brief Summary

This study aims to apply autologous differentiated myocyte subcutaneous transplantation in patients with muscle atrophy to explore its safety, feasibility, and efficacy.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1

Timeline
18mo left

Started Jul 2026

Geographic Reach
1 country

2 active sites

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress6%
Jul 2026Feb 2028

First Submitted

Initial submission to the registry

February 8, 2026

Completed
15 days until next milestone

First Posted

Study publicly available on registry

February 23, 2026

Completed
4 months until next milestone

Study Start

First participant enrolled

July 1, 2026

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2028

Last Updated

February 23, 2026

Status Verified

February 1, 2026

Enrollment Period

1.6 years

First QC Date

February 8, 2026

Last Update Submit

February 15, 2026

Conditions

Metabolic DiseaseAmyotrophy

Keywords

Autologous myocyte transplantationmuscle atrophyMuscle endocrine function

Outcome Measures

Primary Outcomes (15)

  • Blood pressure

    Use electrocardiographic monitoring to assess blood pressure during the perioperative period. Blood pressure will be reported in millimeters of mercury (mmHg).

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    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.

    through study completion, an average of 1 year

Study Arms (1)

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.

Biological: Autologous differentiated myocyte transplantation

Interventions

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.

Autologous differentiated myocyte transplantation

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • Any other medical or ethical conditions deemed by the investigator to make the participant unsuitable for enrollment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Binhai Yangshi Orthopedic Hospital

Yancheng, Jiangsu, China

Location

National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation-Chinese PLA General Hospital

Beijing, China

Location

MeSH Terms

Conditions

Metabolic DiseasesMuscular Atrophy

Condition Hierarchy (Ancestors)

Nutritional and Metabolic DiseasesNeuromuscular ManifestationsNeurologic ManifestationsNervous System DiseasesAtrophyPathological Conditions, AnatomicalPathological Conditions, Signs and SymptomsSigns and Symptoms

Study Officials

  • Pengbin YIn

    National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Honglin Xiang

CONTACT

+8618482610634xianghonglin98@gmail.com

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: 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.
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 8, 2026

First Posted

February 23, 2026

Study Start

July 1, 2026

Primary Completion (Estimated)

February 1, 2028

Study Completion (Estimated)

February 1, 2028

Last Updated

February 23, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared at this stage.

Locations

CN(2)