SarcopeniaPhase 1/2CGBM1-SAR-01NCT07865676
Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Sarcopenia
A Phase 1/2 study testing CG-BM1- 5.0 × 10^7 cells and CG-BM1-1.0 × 10^8 cells in people with Sarcopenia, run by GuangZhou Cellgenes Biotechnology Co., Ltd. at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 50 to 85 years
- Conditions the study is for
- Sarcopenia
- What is being tested?
- CG-BM1- 5.0 × 10^7 cells and CG-BM1-1.0 × 10^8 cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to 31 Oct 2029
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Guangdong Provincial People's Hospital
Guangzhou
Xue Yumei, Chief Physician, +86 13570082363, xymgdci@163.com
About this study
Official title: An Early Exploratory Clinical Trial to Evaluate CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Sarcopenia
- To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Sarcopenia.
- To observe the preliminary effectiveness of CG-BM1 in treating Sarcopenia patients.
- Conditions
- Sarcopenia
- Being tested
- CG-BM1- 5.0 × 10^7 cells, CG-BM1-1.0 × 10^8 cells
- Medical subject headings
- Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CG-BM1- 5.0 × 10^7 cellsBiological
Administered procedure of CG-BM1is 5.0 × 10^7 cells/participant once a month for a total of 2 administrations.
CG-BM1-1.0 × 10^8 cellsBiological
Administered procedure of CG-BM1is 1.0 × 10^8 cells/participant once a month for a total of 2 administrations.
| Study group | Role | What they receive |
|---|---|---|
| CG-BM1- 5.0 × 10^7 cells | Experimental | Administered procedure of CG-BM1 is 5.0 × 10^7 cells/participant once a month for a total of 2 administrations. Conventional treatment includes nutritional support, symptomatic treatment, and other comprehensive care. Receives: Biological: CG-BM1- 5.0 × 10^7 cells |
| CG-BM1- 1.0 × 10^8 cells | Experimental | Administered procedure of CG-BM1is 1.0 × 10^8 cells/participant once a month for a total of 2 administrations. Conventional treatment includes nutritional support, symptomatic treatment, and other comprehensive care. Receives: Biological: CG-BM1-1.0 × 10^8 cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 days after the last administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2026
- Study start30 Apr 2026
- Primary completion30 Jun 2029 (estimated)
- Study completion31 Oct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SarcopeniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07865676
- Sponsor's protocol ID
- CGBM1-SAR-01
- Acronym
- CGBM1-SAR-01
- Status last verified
- Oct 2026
- First submitted
- 3 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No