Stem cell shot for frailty? small study tests safety and promise

NCT ID NCT07449364

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

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

10 people

The number who actually took part.

Started

Mar 2025

Finished

Dec 2025

Lead sponsor

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

60 to 85 years

Sex

Anyone

Healthy volunteers

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

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.

Frailty

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Contacts and locations

Locations

  • Central Army Hospital Gatot Soebroto

    Jakarta Pusat, Jakarta Special Capital Region, 10410, Indonesia

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