Frailty in Older AdultsNCT07449364
Allogeneic Human Mesenchymal Stem Cell Infusion for Frailty Patient
A study testing Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC) in people with Frailty in Older Adults, run by Daewoong Group Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 to 85 years
- Conditions the study is for
- Frailty in Older Adults
- What is being tested?
- Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteIndonesia
- Study dates
- 24 Mar 2025to 5 Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Central Army Hospital Gatot Soebroto
Jakarta Pusat, Jakarta Special Capital Region, 10410
About this study
Official title: Therapeutic Study to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Frailty Patients
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
Read the detailed description
Frailty is defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. The prevalence of frailty varies between populations in different countries. A meta-analysis conducted from 240 studies across 62 countries, using the Frailty Index, showed that the prevalence of frailty and prefrailty among elderly people is 24% and 49%, respectively. In Indonesia, a meta-analysis showed that, using the frailty index, the prevalence of frailty and pre-frailty among elderly people is 26.8% and 55.5%, respectively. These data indicate that the prevalence of frailty and prefrailty in Indonesia is above the world average. This high prevalence of frailty in Indonesia will also become a serious problem, especially considering the various burdens that may arise as a result of frailty, such as geriatric syndromes, disability, mortality, and even cognitive impairment.
Stem cell therapy is proven to help reversing and slowing the progression of physical frailty through: improving the age-dependent senescence, restoring the frailty-related stem cell depletion, inhibit chronic inflammation, improving imbalance of immune homeostasis, restoring the reduction of multipotent stem cells. Mesenchymal Stem Cell (MSC) as one of the options for therapy of frailty becoming one of the future promising treatments. Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSCs) become one of the popular types of Mesenchymal Stem Cell (MSC)'s origin, not only because of its promising immunomodulatory and anti-inflammatory properties, but also because of its safety and less ethical issues. Mesenchymal Stem Cell (MSC) proven too able to contribute in improving frailty condition through components, including neuroprotective effect, cardioprotective effect, muscle protective effect, and therapeutic effect on hormone. This study aimed to evaluate the safety and potential therapeutic effect of allogeneic human mesenchymal stem cell infusion in frailty patients.
- Conditions
- Frailty in Older Adults
- Being tested
- Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC)
- Keywords
- Stem Cell, Frailty, UC-MSC
- Medical subject headings
- Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Biological: Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety evaluation
Safety evaluation will be measured by the incidence of Serious Adverse Events (SAEs)
Measured: 1, 3, and 6 months
Safety evaluation
Safety will be assessed by evaluating thromboembolism risk as indicated by d-dimer level
Measured: 2 hours, 1 month, 3 months, and 6 months
Efficacy evaluation (Frailty state)
Frailty state condition will be evaluated using the Frail questionnaires
Measured: 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)
Measured: 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),
Measured: 1, 3, and 6 months
Efficacy evaluation (Inflammatory biomarkers)
Inflammatory biomarkers will be evaluated using Leptin and D-dimer
Measured: 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)
Measured: 1, 3, and 6 months
Efficacy evaluation (Immune system biomarkers)
Immune system biomarkers will be evaluated including Cell T Regulator
Measured: 1, 3, and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2026
- Study start24 Mar 2025
- Primary completion5 Dec 2025
- Study completion5 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Frailty in Older AdultsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Daewoong Group Indonesia
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Daewoong Pharmaceutical Indonesia
- Responsible party
- Sponsor
- Investigators
- dr. Jonny Sp.PD-KEGH, MM, M.Kes, Post-doc, Principal investigator, Central Army Hospital Gatot Soebroto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07449364
- Sponsor's protocol ID
- DBI-UCMSC62001
- Status last verified
- Mar 2026
- First submitted
- 25 Feb 2026
- Last updated
- 4 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Study to Evaluate the Safety and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Frailty Patients
- ClinicalTrials.gov ID
- NCT07449364
- Acronym / sponsor ID
- DBI-UCMSC62001
- Conditions
- Frailty in Older Adults
- Keywords
- Stem Cell, Frailty, UC-MSC
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Daewoong Group IndonesiaIndustry (pharma, biotech, devices)
- Collaborators
- Daewoong Pharmaceutical Indonesia
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 5 Dec 2025 (actual)
- Study completion
- 5 Dec 2025 (actual)
- First posted
- 4 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Frailty is defined as a clinically recognizable state of increased vulnerability resulting from aging-associated decline in reserve and function across multiple physiologic systems such that the ability to cope with every day or acute stressors is comprised. The prevalence of frailty varies between populations in different countries. A meta-analysis conducted from 240 studies across 62 countries, using the Frailty Index, showed that the prevalence of frailty and prefrailty among elderly people is 24% and 49%, respectively. In Indonesia, a meta-analysis showed that, using the frailty index, the prevalence of frailty and pre-frailty among elderly people is 26.8% and 55.5%, respectively. These data indicate that the prevalence of frailty and prefrailty in Indonesia is above the world average. This high prevalence of frailty in Indonesia will also become a serious problem, especially considering the various burdens that may arise as a result of frailty, such as geriatric syndromes, disability, mortality, and even cognitive impairment.
Stem cell therapy is proven to help reversing and slowing the progression of physical frailty through: improving the age-dependent senescence, restoring the frailty-related stem cell depletion, inhibit chronic inflammation, improving imbalance of immune homeostasis, restoring the reduction of multipotent stem cells. Mesenchymal Stem Cell (MSC) as one of the options for therapy of frailty becoming one of the future promising treatments. Umbilical Cord-derived Mesenchymal Stem Cell (UC-MSCs) become one of the popular types of Mesenchymal Stem Cell (MSC)'s origin, not only because of its promising immunomodulatory and anti-inflammatory properties, but also because of its safety and less ethical issues. Mesenchymal Stem Cell (MSC) proven too able to contribute in improving frailty condition through components, including neuroprotective effect, cardioprotective effect, muscle protective effect, and therapeutic effect on hormone. This study aimed to evaluate the safety and potential therapeutic effect of allogeneic human mesenchymal stem cell infusion in frailty patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 100 million cells of investigational product for 30 minutes per package using a syringe pump. | Experimental | Biological: Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC)100 million cells of investigational product for 30 minutes per package using a syringe pump. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Biological | 100 million cells of investigational product for 30 minutes per package using a syringe pump. |
Primary outcome
Safety evaluation
Time frame: 1, 3, and 6 months
Safety evaluation will be measured by the incidence of Serious Adverse Events (SAEs)
Safety evaluation
Time frame: 2 hours, 1 month, 3 months, and 6 months
Safety will be assessed by evaluating thromboembolism risk as indicated by d-dimer level
Efficacy evaluation (Frailty state)
Time frame: 1, 3, and 6 months
Frailty state condition will be evaluated using the Frail questionnaires
Efficacy evaluation (Patient quality of life)
Time frame: 1, 3, and 6 months
Patient quality of life will be evaluated using Short-Form 12 Health Survey (SF-12)
Efficacy evaluation (Inflammatory biomarkers)
Time frame: 1, 3, and 6 months
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),
Efficacy evaluation (Inflammatory biomarkers)
Time frame: 1, 3, and 6 months
Inflammatory biomarkers will be evaluated using Leptin and D-dimer
Efficacy evaluation (Immune system biomarkers)
Time frame: 1, 3, and 6 months
Immune system biomarkers will be evaluated including Cluster of Differentiation-4 (CD4) and Cluster of Differentiation-8 (CD8)
Efficacy evaluation (Immune system biomarkers)
Time frame: 1, 3, and 6 months
Immune system biomarkers will be evaluated including Cell T Regulator
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
dr. Jonny Sp.PD-KEGH, MM, M.Kes, Post-doc principal investigator
Central Army Hospital Gatot Soebroto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Daewoong Biologics Indonesia Umbilical Cord-derived Mesenchymal Stem Cell (DBI UC-MSC) in people with Frailty in Older Adults, run by Daewoong Group Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety evaluation (time frame: 1, 3, and 6 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Mar 2026.