Allogeneic Human Mesenchymal Stem Cell Infusion for Frailty Patient

NCT07449364 | Completed

• 1 other identifier: DBI-UCMSC62001
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Stem Cell; Frailty; UC-MSC

Outcome Measures

Primary Outcomes (8)

• Safety evaluation

  Safety evaluation will be measured by the incidence of Serious Adverse Events (SAEs)

  1, 3, and 6 months

• Safety evaluation

  Safety will be assessed by evaluating thromboembolism risk as indicated by d-dimer level

  2 hours, 1 month, 3 months, and 6 months

• Efficacy evaluation (Frailty state)

  Frailty state condition will be evaluated using the Frail questionnaires

  1, 3, and 6 months

• Efficacy evaluation (Patient quality of life)

  Patient quality of life will be evaluated using Short-Form 12 Health Survey (SF-12)

  1, 3, and 6 months

• Efficacy evaluation (Inflammatory biomarkers)

  Inflammatory biomarkers will be evaluated using TNF-α (Tumor necrosis factor-alpha), IL-6 (Interleukin-6), IL-10 (Interleukin-10), and IL-11 (Interleukin 11),

  1, 3, and 6 months

• Efficacy evaluation (Inflammatory biomarkers)

  Inflammatory biomarkers will be evaluated using Leptin and D-dimer

  1, 3, and 6 months

• Efficacy evaluation (Immune system biomarkers)

  Immune system biomarkers will be evaluated including Cluster of Differentiation-4 (CD4) and Cluster of Differentiation-8 (CD8)

  1, 3, and 6 months

• Efficacy evaluation (Immune system biomarkers)

  Immune system biomarkers will be evaluated including Cell T Regulator

  1, 3, and 6 months

Study Arms (1)

100 million cells of investigational product for 30 minutes per package using a syringe pump.

EXPERIMENTAL

100 million cells of investigational product for 30 minutes per package using a syringe pump.

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

Interventions

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

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.

100 million cells of investigational product for 30 minutes per package using a syringe pump.

Eligibility Criteria

• Age: 60 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age of 60-85 years old at the time of screening
• Those who have been confirmed frailty indication through The Frail questionnaires
• Those who voluntarily decided to participate in the study and wrote the informed consent form
• Those who are suitable as subjects for this study when judged by physical examination, clinical test, medical test, et cetera

You may not qualify if:

• Subject that not able to perform any of the assessments required for endpoint analysis
• Those who have hypersensitivity reaction or a history of hypersensitivity to the components of the investigational product or the investigational product
• Subject with Mini Mental State Examination (MMSE) score less than 24
• Abnormal laboratory result, including Hemoglobin (Hb) \<8 g/dl, Leukocyte \<3000/mm3, platelets \<80,000/mm3, International Normalized Ratio (INR) \> 1.5, aspartate transaminase and alanine transaminase \> 3 times upper limit of normal, total bilirubin \> 1.5 mg/dl, serum creatinine \> 2 mg/dL
• Organ transplant recipient or already listed (or expected to be listed) for transplantation of any organ
• Patient taking immunosuppressive drugs within 6 months of screening
• Having serious comorbidities that may compromise the safety and compliance of the patient based on investigator judgement, including but not limited to: 1) Heart: unstable angina, myocardial infarction, class III/IV congestive heart failure, cardiac revascularization within the last six months, 2) Liver: Advanced liver failure, 3) Renal: Advanced renal failure, 4) Pulmonary: Severe obstructive ventilatory defect, history of pulmonary embolism, 5) Other: Human Immunodeficiency Virus/Acquired Immunodeficiency Syndrome (HIV/AIDS), Hepatitis B Surface Antigen (HBsAg) positive, Hepatitis C virus (HCV) positive, uncontrolled hypertension, uncontrolled blood glucose
• Patient who had cancer disease within 5 years and no malignancy suspected from the result of tumor marker screening
• Patient that participating in other investigational therapeutic or device trial
• Patient with life expectancy less than 1 year
• Patient who are pregnant, nursing, and/or having a childbearing potential while not having effective contraceptive method
• Those who are determined by the investigator to be unsuitable for participation in the clinical trial due to other reasons including the results of the clinical laboratory test

Sponsors & Collaborators

• Daewoong Group Indonesia: lead
• Daewoong Pharmaceutical Indonesia: collaborator

Study Sites (1)

Central Army Hospital Gatot Soebroto

Jakarta Pusat, Jakarta Special Capital Region, 10410, Indonesia

Location

MeSH Terms

Conditions

Frailty

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• dr. Jonny Sp.PD-KEGH, MM, M.Kes, Post-doc

  Central Army Hospital Gatot Soebroto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 4, 2026
• Study Start: March 24, 2025
• Primary Completion: December 5, 2025
• Study Completion: December 5, 2025
• Last Updated: March 4, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)