Stem cells aim to keep dialysis lifelines open

NCT ID NCT04392206

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
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
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 10, 2026 · Last updated Jul 10, 2026

Summary

This early-stage trial tests whether stem cells from donated fat tissue can help prevent narrowing at the connection point of a dialysis access site in people with end-stage kidney disease. The study enrolls 15 adults who are already scheduled for fistula creation. Researchers will monitor for side effects and measure how well the access site works over time.

What this could mean

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

Active substance
Adipose Derived Mesenchymal Stem Cells (AMSC)
What this could lead to
If safe and effective, this approach could help people on dialysis maintain better blood flow through their access site, reducing the need for repeat procedures.
What could go wrong
This is a very early Phase 1 trial with only 15 participants, so it is primarily testing safety, not effectiveness. There is a risk of inflammation, infection, or blood flow problems.

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

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

About 15 people

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

Started

May 2020

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 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: * Patient between 18 and 85 years old * Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy * Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures * Life expectancy of at least 24 months * If female, must be post-menopausal or not able to have children. Post-menopausal/non-child bearing status must be clearly documented in the medical record. If documentation of post-menopausal/non-child bearing status is not available then a pregnancy test must be performed. Exclusion Criteria: * Malignancy or treatment for malignancy within the previous 6 months * Immunodeficiency including AIDS / HIV or Active autoimmune disease * Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events * Treatment with any investigational drug/ device within 60 days prior to study entry or Any other condition which in the judgment of the investigator would preclude adequate evaluation of the safety and efficacy of AMSCs and the AVF * History of failed organ transplant on immunosuppression. * Subjects with known active infection (infection which is being treated)

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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.

  1. The places running it

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

  2. 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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  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

  • Mayo Clinic in Florida

    RECRUITING

    Jacksonville, Florida, 32224, United States

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