Stem cells aim to reverse frailty in the elderly
NCT ID NCT07144072
First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time
Summary
This early-stage trial tests a new stem cell treatment called HeXell-2020 in 12 elderly people with mild to moderate frailty. The treatment uses donated umbilical cord stem cells given through an IV. The main goal is to check safety and find the best dose, not yet to prove it works.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- HeXell-2020 (umbilical cord stem cells)
- What this could lead to
- If safe and effective, this could point toward a treatment to improve physical function and reduce frailty in older adults.
- What could go wrong
- This is a very early, small Phase 1 trial with only 12 people, focused on safety. It is not designed to prove the treatment works, and side effects or lack of benefit are possible.
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
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- 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: Subjects will be eligible for enrollment in the study only if they meet ALL the following criteria at time of Screening: 1. Subjects aged ≥ 60 through ≤ 85 years old. 2. Subjects with clinical diagnosis of mild to moderate Frailty Syndrome as assessed by the Investigator with a Clinical Frailty Scale score between 4 to 6. 3. Subject will not start any new treatment for this condition during the study. 4. Subjects with body weight between 40 to 90 kg. 5. Subject is willing to provide written informed consent to participate in the study after reading the informed consent form and the information provided. Exclusion Criteria: Subjects meeting ANY of the following criteria at time of Screening will be excluded from enrollment: 1. Subjects unwilling or unable to perform any of the assessments required by endpoint analysis. 2. Subjects who have a diagnosis of any disabling neurologic disorder including, but not limited to: Parkinson's disease, Amyotrophic Lateral Sclerosis, multiple sclerosis, stroke or dementia. 3. Subjects who have a score on the Mini-Mental State Examination (MMSE) of 24 or below. 4. Subjects who have a significant comorbid medical condition(s) including, but not limited to: 1. Severe kidney disease requiring hemodialysis or peritoneal dialysis; 2. Advanced liver disease such as severe liver cirrhosis; 3. Severe congestive heart failure (NYHA class 3 and 4); 4. Severe pulmonary dysfunction, including severe chronic obstructive pulmonary disease stage III or IV (Gold classification) 5. Subjects who have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively-treated basal cell carcinoma or in situ carcinomas. 6. Subjects using chronic immunosuppressant therapy, including corticosteroids (\> 5 mg/day of prednisone, or equivalent), or TNF-alpha antagonists. 7. Subjects on chronic immunosuppressive transplant therapy. 8. Subjects who have participated in another clinical study of new investigational therapies within 6 months prior to screening. 9. Subjects who have received any other stem cell therapy within 12 months prior to screening. 10. Subjects with known allergy or hypersensitivity to any component of the formulation and cellular therapies (i.e., penicillin or streptomycin). 11. Subjects who have a history of drug or alcohol abuse within the past 3 years. 12. Subjects who are known to be infected with HIV. 13. Subjects currently in hospital stay. 14. Subjects who have a significant illness as judged by principal investigator (PI) including, but not limited to: 1. Psychiatric illness 2. Uncontrolled hypertension or hypotension 3. Unstable cardiac arrhythmia 4. Active Hepatitis B, Hepatitis C infections 15. Subjects who have any condition that in the opinion of the Principal Investigator limits lifespan to \< 1 year. 16. Subjects who have any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
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Other studies related to the condition(s) this trial covers.
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