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Allogeneic Human Mesenchymal Stem Cell Infusion for Frailty Patient

NCT07449364 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2026-03-04

No results posted yet for this study

Summary

Subjects will be provided a written informed consent to participate in the study and then undergo any screening. Subjects who meet all the inclusion criteria and none of the exclusion criteria based on the screening test results will be included into the study. At treatment day, the subjects will be administered 100 million cells of investigational product for 30 minutes for each package using a syringe pump. After 4 weeks (1 month) of Investigational product administration, the subjects will visit the study site to evaluate the safety and efficacy of investigational products. Follow up visits for potential efficacy will also be conducted after 12 weeks (3 months) and 24 weeks (6 months) of Investigational product administration. If necessary, additional examination and treatment may be performed according to the investigator's judgment

Conditions

  • Frailty in Older Adults

Interventions

BIOLOGICAL

Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC)

The investigational product will be in ready-to-use package in 50 ml syringes, containing 50 million cells in a saline solution with 5% dextrose and 3% human serum albumin. Each participant will receive two packages. The prepared suspension should be administered to the subjects via Intravenous (IV) infusion. The entire suspension should be infused over a 30-minute period per package using a syringe pump.

Sponsors & Collaborators

  • Daewoong Pharmaceutical Indonesia

    collaborator UNKNOWN

  • Daewoong Group Indonesia

    lead INDUSTRY

Principal Investigators

  • dr. Jonny Sp.PD-KEGH, MM, M.Kes, Post-doc · Central Army Hospital Gatot Soebroto

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-24
Primary Completion
2025-12-05
Completion
2025-12-05

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07449364 on ClinicalTrials.gov