NCT07426068

Clinical Safety Evaluation and Preliminary Efficacy Study of Subcutaneous Myografts Transplantation

• Status: Not Yet Recruiting
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: National Clinical Research Center for Orthopedics, Sports Medicine and Rehabilitation, China · Network
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Metabolic Disease
• Amyotrophy

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-07-01
• Primary completion: 2028-02-01
• Completion: 2028-02-01
• First posted: 2026-02-23
• Last updated: 2026-02-23

Locations

2 sites across 1 country: China