💬In plain words
What the trial is, and whether it could suit you
1. To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Sarcopenia.
2. To observe the preliminary effectiveness of CG-BM1 in treating Sarcopenia patients.
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
* Voluntary participation; participant or legal guardian fully understands the study and provides written informed consent; participant is willing and able to comply with all study procedures.
* Male or female, aged ≥50 to \<85 years at screening.
* Meets the Asian Working Group for Sarcopenia (AWGS) 2025 diagnostic criteria for sarcopenia.
* Body weight \>35 kg and unwilling or unable to perform regular resistance exercise training during the study.
* Male participants must agree not to father a child, and female participants must not be pregnant or breastfeeding; female participants of childbearing potential must use effective contraception. These requirements apply from informed consent through the final visit.
Exclusion Criteria:
* Known hypersensitivity to any component of CG-BM1 (human bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide and human serum albumin).
* Regular use of growth hormone or steroid hormones (e.g., androgens, estrogens,glucocorticoids) within 3 months before screening; inhaled glucocorticoids and vitamin D are permitted.
* Severe systemic disease, including but not limited to NYHA Class III-IV heart failure; end-stage lung disease; renal impairment with eGFR \<30 mL/min/1.73 m²; Child-Pugh Class C hepatic impairment; severe gastrointestinal disease or inability to eat normally; severe infection; or prolonged bed rest.
* Neurological disability, including but not limited to Parkinson's disease, amyotrophic lateral sclerosis, multiple sclerosis, stroke sequelae (e.g., muscle weakness or gait abnormality), or dementia.
* History of malignancy.
* Pulmonary embolism within 3 months before screening or deep vein thrombosis at screening;low-risk intermuscular venous thrombosis is permitted.
* Previous stem cell therapy.
* Participation in another interventional clinical trial within 3 months or 5 half-lives (for investigational drug interventions; whichever is longer) before study drug infusion.
* Any other condition that, in the investigator's opinion, makes the participant unsuitable for this trial.
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