Bone marrow mesenchymal stem cell injection for sarcopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional study combines Phase 1 and Phase 2 to assess the safety and tolerability of CG-BM1 at two cell doses in adults aged 50 to 84 with sarcopenia. Participants receive CG-BM1 injections and are monitored for adverse events and preliminary signs of benefit on muscle function and strength. Eligibility requires AWGS 2025-confirmed sarcopenia, adequate body weight, and inability to participate in regular resistance training. Exclusion criteria include hypersensitivity to CG-BM1 components and ongoing use of certain hormones. The trial is led by GuangZhou Cellgenes Biotechnology with Guangdong Provincial People's Hospital as the site in Guangzhou, China.

Why it matters

Who can join: the full rules

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.

Where it's running

• Guangdong Provincial People's Hospital
  Guangzhou, China Recruiting

Study contacts

• Study coordinator: Zeng Liping, Senior Medical Director
• Email: Ip.zeng@cellgenes.com
• Phone: +86 20 82514048

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.