Stem cells aim to keep dialysis lifelines open
NCT ID NCT04392206
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 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: * 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)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for End stage renal disease are added.
By submitting, you agree to our Terms of use
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.
-
The places running it
1 site. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
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
RECRUITINGJacksonville, Florida, 32224, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Can tweaking dialysis sodium flush out hidden salt and protect blood vessels?
- Can dialysis filters improve kidney recovery? a data review seeks answers
- Can a damaged kidney change how a Weight-Loss drug works?
- Dialysis patients may fight frailty with home video workouts
- Lab-Grown vessels could revolutionize dialysis access
- Can a biological graft improve dialysis access?