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Can your own stem cells reverse frailty? suspended trial holds clues

NCT ID NCT03514537

Disease control Sponsor: Healeon Medical Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 This study
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This trial tests whether a person's own stem cells, taken from fat tissue and given back through an IV, can safely improve quality of life and physical function in people with aging frailty. The study plans to enroll 200 adults aged 40 to 90 who have lost energy and exercise tolerance. The trial is currently suspended, so results are not yet available.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous stem/stromal cells from fat tissue
What this could lead to
If it works, this could point toward a treatment to improve mobility and energy in frail older adults.
What could go wrong
This is an early, suspended trial with no phase, so results are uncertain. Risks include side effects from the cell infusion procedure.

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

About 200 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2018

Expected to finish

Jan 2028

An estimate. End dates often move.

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

40 to 90 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

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: * Be \>40 and \<90 years of age and willing and able to provide written informed consent * Those aging and frail patients who have noted compromise to activities or work requirements due to increasing age * Ability to execute a 6 minute walk test distance of \>200 meters and \<1000 meters * Loss of energy and exercise tolerance over 6 month period minimum * Current clinical history of malignancy within 3 years, except for curable skin lesions including basal cell carcinoma, or squamous cell carcinoma * Must have the ability to provide Informed Consent Exclusion Criteria: * Medical conditions which prevent the ability of assessment of walk distance testing criteria * Have disabling neurodegenerative disorder which would impede interpretation of outcomes * Have a score of \<24 on the Mini Mental State Examination (MMSE) * History of malignancy within 2 years (excluding curative skin lesion of basal cell carcinoma, melanoma-in-situ, or cervical carcinoma * Have clinically important abnormal screening laboratory values, including, but not limited to: Hemoglobin \<10 g/dL; White blood cell count (WBC) \<2500/mL; Platelet count microliters \<100000/uL(microliters); Genetic Coagulopathy history * Uncontrollable hypertension * Systemic disorders that preclude completion of the testing or out of medical management control in the opinion of the PIs or Primary Care Provider * Expected lifespan of less that 6 months * Current drug abuse history \< 6 months * Alcohol abuse within 6 months of enrollment * Serious or life threatening co-morbidities that in the opinion of investigators, may compromise the safety or compliance with the study guidelines and tracking.

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Conditions

The condition(s) this trial relates to.

neurodegenerative disease

As listed by the trial registrant

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

Aging Degenerative disease Frail elderly syndrome

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    Open the record ↗

  3. 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.

Contacts and locations

Locations

  • Fanny Island Campus Medical Building

    Colchester, Vermont, 05446, United States

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