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RecruitingNCT07865676CGBM1-SAR-01Updated Oct 8, 2026

Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Sarcopenia

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

From the registry’s dates

  • Registered 5 months after the study started (first participant enrolled Apr 2026, registered Oct 2026).
  • Started Apr 2026; still recruiting 5 months later.
Updated Oct 8, 2026Newly registeredGo to Updates ↓
Phase
Phase 1/2
Study type
Interventional
Enrollment
30
Allocation
Non-randomized
Ages
50 Years to 85 Years
Sex
All
01

Study 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.
02

Conditions studied

  • Sarcopenia

Browse trials for

03

In context

Sarcopenia

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 →

Lead sponsor

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.

04

Who can participate

Ages eligible
50 Years to 85 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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

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.

05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (estimated)

Study arms

  • Experimental
    Experimental Group 1

    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

  • Experimental
    Experimental Group 2

    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

Interventions

  • BiologicalCG-BM1

    Intravenous infusion, once monthly for a total of 2 administrations.

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 of 1 sites recruiting
  • Guangdong Provincial People's Hospital
    Guangzhou, China
    • Xue Yumei, Chief Physician · Contact · xymgdci@163.com · +86 13570082363
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Registered
First appeared on the registry. No changes since
Oct 8, 2026
Show all 1 update
  1. Oct 8, 2026
    First appeared on the registry

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 ↗

09

Registry details

Key details

Study ID
NCT07865676
Lead sponsor
GuangZhou Cellgenes Biotechnology Co., Ltd.
Responsible party
Sponsor
First posted
Oct 8, 2026
Start date
Apr 30, 2026
Primary completion
Jun 30, 2029 (estimated)
Completion
Oct 31, 2029 (estimated)
Last update
Oct 8, 2026

Study contacts

Zeng Liping, Senior Medical Director
Contact
Ip.zeng@cellgenes.com
+86 20 82514048

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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