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

ConditionSarcopenia
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age50-85
SponsorGuangZhou Cellgenes Biotechnology Co., Ltd.

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

1. Known hypersensitivity to any component of CG-BM1 (human bone marrow mesenchymal stem cells; excipients include dimethyl sulfoxide and human serum albumin).

Trial design

Design model

Parallel

Treatments tested in this trial

  • CG-BM1

    Biological/Vaccine

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

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Experimental Group 1Experimental treatment 1 intervention
Group B: Experimental Group 2Experimental treatment 1 intervention

Trial outcomes

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

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

GuangZhou Cellgenes Biotechnology Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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