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

NCT07865676 | Recruiting Phase 1

• 1 other identifier: CGBM1-SAR-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.To evaluate the safety and tolerability of CG-BM1 for the treatment of patients with Sarcopenia.
2. 2.To observe the preliminary effectiveness of CG-BM1 in treating Sarcopenia patients.

Conditions

Sarcopenia

Outcome Measures

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.

  30 days after the last administration

Study Arms (2)

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.

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.

Biological: CG-BM1-1.0 × 10^8 cells

Interventions

CG-BM1- 5.0 × 10^7 cells BIOLOGICAL

Administered procedure of CG-BM1is 5.0 × 10\^7 cells/participant once a month for a total of 2 administrations.

CG-BM1- 5.0 × 10^7 cells

CG-BM1-1.0 × 10^8 cells BIOLOGICAL

Administered procedure of CG-BM1is 1.0 × 10\^8 cells/participant once a month for a total of 2 administrations.

CG-BM1- 1.0 × 10^8 cells

Eligibility Criteria

• Age: 50 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GuangZhou Cellgenes Biotechnology Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, China

RECRUITING

MeSH Terms

Conditions

Sarcopenia

Condition Hierarchy (Ancestors)

Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Zeng Liping, Senior Medical Director

CONTACT

+86 20 82514048; Ip.zeng@cellgenes.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 3, 2026
• First Posted: October 8, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): June 30, 2029
• Study Completion (Estimated): October 31, 2029
• Last Updated: October 14, 2026

Record last verified: 2026-10

Locations

CN (1)