Muscle injury
Conditions
Interventions
Trial group:Treatment with stem cell-derived exosomes delivered via microneedles, with administration via microneedle application, at a dose of 1×10^10 exosomal particles, administered as a single dos
Control group:Saline therapy delivered by microneedles, with the administration route of microneedle delivery, a dose of an equal volume of saline, and a frequency of single administration per clinica
Sponsors
Chinese People's Liberation Army General Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 60 years (inclusive), regardless of gender;2. Clinically confirmed diagnosis of skeletal muscle injury, including a clear medical history (e.g., trauma history, strenuous exercise history, or other predisposing factors); clinical manifestations such as varying degrees of pain, swelling, tenderness, and limited mobility at the affected site; some cases may present with decreased muscle strength or dysfunction, and severe cases may be accompanied by local subcutaneous ecchymosis, deformity, or a sunken sensation; imaging examinations (ultrasound, MRI) showing local muscle tears, hemorrhage, inflammation, edema, or scar formation.3.The muscle injury site is suitable for microneedling intervention, with good skin condition and no obvious infection, open wounds, or severe scars;4. The subject is in good general condition and can tolerate the microneedling treatment process as evaluated clinically;5. The subject provides informed consent, can understand the research purpose, content, and potential risks, voluntarily signs the Informed Consent Form, and cooperates with follow-up;6. Has good compliance and can complete the entire research process in accordance with the protocol.
Exclusion criteria
Exclusion criteria: 1. Severe dysfunction of major organs such as the heart, brain, liver, or kidneys, or active major diseases;2. Complicated with coagulation disorders, hemorrhagic diseases, or recent use of anticoagulant/antiplatelet drugs, with a significant risk of bleeding;3.Infections, open wounds, active skin diseases, or obvious scars at the skin of the muscle injury site that affect drug administration or operation;4. Pregnant women, lactating women, or those planning to become pregnant;5. Mental or psychological diseases that affect compliance and inability to cooperate with the research process;6.Participation in other clinical trials that may affect the judgment of efficacy during the intervention period of this study;7. Other circumstances deemed inappropriate for participation in this study by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Ultrasound examination;MRI Examination;Blood biochemistry test;Blood routine test;Muscle strength test;Muscle Function Evaluation Scale;Pain Assessment; | — |
Countries
China
Contacts
Public ContactYin Pengbin
Chinese People's Liberation Army General Hospital
Outcome results
None listed