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
- Are there results?
- Not yet: the study is under way
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
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Trial to Evaluate CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Sarcopenia
- ClinicalTrials.gov ID
- NCT07865676
- Acronym / sponsor ID
- CGBM1-SAR-01 / CGBM1-SAR-01
- Conditions
- Sarcopenia
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- GuangZhou Cellgenes Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- 30 Jun 2029 (estimated)
- Study completion
- 31 Oct 2029 (estimated)
- First posted
- 8 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CG-BM1- 5.0 × 10^7 cells | Experimental | Biological: CG-BM1- 5.0 × 10^7 cellsAdministered 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. |
| CG-BM1- 1.0 × 10^8 cells | Experimental | Biological: CG-BM1-1.0 × 10^8 cellsAdministered 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. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CG-BM1- 5.0 × 10^7 cellsAdministered procedure of CG-BM1is 5.0 × 10^7 cells/participant once a month for a total of 2 administrations. | Biological | CG-BM1- 5.0 × 10^7 cells |
| CG-BM1-1.0 × 10^8 cellsAdministered procedure of CG-BM1is 1.0 × 10^8 cells/participant once a month for a total of 2 administrations. | Biological | CG-BM1- 1.0 × 10^8 cells |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
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.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zeng Liping, Senior Medical Director (+86 20 82514048, Ip.zeng@cellgenes.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2026.