None listed
Conditions
Interventions
Biological/Vaccine, Stem Cell : Experimental Group 1: One-time intravenous administration of autologous adipose-derived stromal vascular fraction (SVF)
Experimental Group 2: One-time intravenous admin
Sponsors
Chel Orthopedic Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) The subject has voluntarily provided written informed consent to participate in this clinical study 2) The subject is aged = 60 years at the time of written informed consent 3) The subject is diagnosed with sarcopenia according to Asian criteria (must meet ? and either ? or ?) ? Appendicular skeletal muscle mass index (ASMI) measured by DEXA: Male < 7.0 kg/m² / Female < 5.4 kg/m² ? Grip strength: Male < 28 kg / Female < 18 kg ? Short Physical Performance Battery (SPPB) score = 9 4) Body weight = 35 kg and body mass index (BMI) = 18.5 and < 30 kg/m² 5) Abdominal subcutaneous fat thickness = 2 cm measured by ultrasonography 6) Hemoglobin = 9.5 g/dL
Exclusion criteria
Exclusion criteria: 1) Unable to perform required study assessments (e.g., safety/tolerability reporting, pulmonary function testing, blood sampling, reading and responding to questionnaires) 2) Awaiting or scheduled for organ transplantation 3) Significant functional impairment within 24 weeks (fracture, severe OA, neuro/vascular disease, etc.)However, participation may be allowed if recovery of physical function is confirmed by the investigator with a Koval score of 1 4) SPPB = 10 at screening 5) Neuromuscular or neurological disorders 6) Underlying muscle disease (myopathy, muscle atrophy) 7) Severe cardiac disease (e.g., NYHA = III, ACS, arrhythmia) 8) Malignancy within 5 years 9) Recent intraocular surgery (within 6 months) 10) Chronic kidney disease (eGFR 8.5%) 12) Moderate/severe COPD 13) Severe liver disease (e.g., cirrhosis) 14) Uncontrolled thyroid disorder 15) Uncontrolled hypertension or significant hypotension 16) Alcohol intake = 140 g/week 17) Recent high-intensity resistance exercise (within 12 weeks) 18) Significant comorbid condition affecting safety/compliance 19) Participation in another clinical trial within 30 days 20) Investigational product/device within 12 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety Assessment : vital signs, physical examinations, clinical laboratory parameters, adverse events, and concomitant medications. | — |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy Assessments:Changes from baseline in muscle mass, handgrip strength (HGS), and Short Physical Performance Battery (SPPB) score, as well as activities of daily living assessed using the SARC-F questionnaire. | — |
Countries
Korea, Republic of
Contacts
Public ContactHyun-Jin Kim
Chel Orthopedic Hospital
Outcome results
None listed