Stem cell shot for frailty? small study tests safety and promise
NCT ID NCT07449364
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested whether a single infusion of donor stem cells is safe and could help reduce frailty in older adults aged 60 to 85. Ten participants received the cells and were monitored for six months. Researchers checked for side effects, frailty levels, quality of life, and changes in blood markers of inflammation and immunity.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2025
- Finished
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Dec 2025
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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60 to 85 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 Exclusion Criteria: * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Central Army Hospital Gatot Soebroto
Jakarta Pusat, Jakarta Special Capital Region, 10410, Indonesia
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Other studies related to the condition(s) this trial covers.
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