NCT07865676 Clinical Trial of CG-BM1 Allogeneic Human Bone Marrow Mesenchymal Stem Cell Injection in the Treatment of Sarcopenia
| NCT ID | NCT07865676 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | GuangZhou Cellgenes Biotechnology Co., Ltd. |
| Condition | Sarcopenia |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2026-04-30 |
| Primary Completion | 2029-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 30 participants in total. It began in 2026-04-30 with a primary completion date of 2029-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07865676 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 85 Years, studying Sarcopenia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07865676 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT07865676 currently recruiting?
Yes, NCT07865676 is actively recruiting participants. Contact the research team at Ip.zeng@cellgenes.com for enrollment information.
Where is the NCT07865676 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT07865676 clinical trial?
NCT07865676 is sponsored by GuangZhou Cellgenes Biotechnology Co., Ltd.. The trial plans to enroll 30 participants.