A Phase 1/2 interventional study of CG-BM1 in Sarcopenia, sponsored by GuangZhou Cellgenes Biotechnology Co., Ltd.. Recruiting at 1 site in China. Open to participants aged 50 Years to 85 Years. Per ClinicalTrials.gov, last updated 2026-10-08.
Sponsored by GuangZhou Cellgenes Biotechnology Co., Ltd. · Phase 1/2, Interventional, and Treatment
1,208 studies on the registry are indexed under Sarcopenia; 402 are open to participants now.
This study's planned enrollment of 30 is below the median of 60 across 775 interventional studies indexed under Sarcopenia.
Browse Sarcopenia studies →This is the only study on the registry with GuangZhou Cellgenes Biotechnology Co., Ltd. as lead sponsor.
Counted across the registry records on this site, refreshed daily.
1. Voluntary participation; participant or legal guardian fully understands the study and provideswritten informed consent; participant is willing and able to comply with all study procedures.
2.Male or female, aged ≥50 to \<85 years at screening. 3.Meets the Asian Working Group for Sarcopenia (AWGS) 2025 diagnostic criteria for sarcopenia.
4. Body weight >35 kg and unwilling or unable to perform regular resistance exercise training during the study.
5.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:
1. Known hypersensitivity to any component of CG-BM1 (human bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide and human serum albumin).
2. 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.
3. 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.
4. 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.
5.History of malignancy. 6. Pulmonary embolism within 3 months before screening or deep vein thrombosis at screening;low-risk intermuscular venous thrombosis is permitted.
7.Previous stem cell therapy. 8. Participation in another interventional clinical trial within 3 months or 5 half-lives (for investigational drug interventions; whichever is longer) before study drug infusion.
9.Any other condition that, in the investigator's opinion, makes the participant unsuitable for this trial.
Paitents in Experimental Group 1 receive CG-BM1+conventional treatment. Administered procedure of CG-BM1 is 5.0 × 10\^7 cells once a month for a total of 2 administrations.Conventional treatment includes nutritional support, symptomatic treatment, and other comprehensive care. Drug: CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection administered once monthly for a total of 2 doses.
Biological: CG-BM1
Paitents in Experimental Group 1 receive CG-BM1 +Conventional treatment . Administered procedure of CG-BM1is 1.0 × 10\^8 cells once a month for a total of 2 administrations.Conventional treatment includes nutritional support, symptomatic treatment, and other comprehensive care. Drug: CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection administered once monthly for a total of 2 doses.
Biological: CG-BM1
Intravenous infusion, once monthly for a total of 2 administrations.
Incidence of study-related adverse events(AE) and serious adverse events(SAE) from the first administration of CG-BM1 to 30 days after the last administration.
Incidence of study-related adverse events(AE) and serious adverse events(SAE) from the first administration of CG-BM1 to 30 days after the last administration.
Time frame: 30 days after the last administration
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.