End Stage Renal Disease (ESRD)Phase 1NCT02808208

Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

A Phase 1 study testing Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC) and Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC) in people with End Stage Renal Disease (ESRD) and Vascular Access Complication, run by Mayo Clinic at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

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Trial summary

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation. Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: End Stage Renal Disease (ESRD), Vascular Access Complication
What is being tested?: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC) and Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 74 participants
Where: 1 siteUnited States
Study dates: 7 Jun 2017to Dec 2026
Phase: Phase 1
Are there results?: Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patient between 18 and 85 years old
Patient currently on hemodialysis or pre-dialysis and planned 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

Who cannot join

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
Pregnancy or breast feeding
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
Employees of the sponsor or patients who are employees or relatives of the investigator
History of failed organ transplant on immunosuppression

Trial locations and contacts

1 site in 1 country.

United States1 site

Mayo Clinic in Rochester
Rochester, Minnesota, 55905

Other trials in United States

About this study

Official title: A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

Conditions: End Stage Renal Disease (ESRD), Vascular Access Complication
Being tested: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC), Placebo, Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Medical subject headings: Kidney Failure, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)Biological
A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.
PlaceboDrug
5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)Biological
Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery

Study groups in NCT02808208
Study group	Role	What they receive
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula	Experimental	Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) Receives: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula	No intervention	Patients receive standard of care.
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula	Experimental	Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF Receives: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula	Experimental	Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF Receives: Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)
Placebo treatment in brachiobasilic arteriovenous fistula	Placebo comparator	Subjects will receive placebo at first and second stage of BBF Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

Hemodialysis outflow vein diameter
Diameter of outflow vein by ultrasound
Measured: Baseline to 12 months after AVF creation

Secondary outcomes (1)

Hemodialysis AVF Blood flow
blood flow by ultrasound or dialysis
Measured: Baseline to 12 months after AVF creation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

7 Jun 2017Dec 2026

First posted21 Jun 2016 (estimated)
Study start7 Jun 2017
Primary completionDec 2026 (estimated)
Study completionDec 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (1)Papers the sponsor has linked to this study.
Other trials for End Stage Renal Disease (ESRD)Studies of the same condition, open and under way.
More trials run by Mayo ClinicThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 1
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 74 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02808208
Sponsor's protocol ID: 15-009053
Status last verified: Jan 2026
First submitted: 2 Jun 2016
Last updated: 7 Jan 2026
Results posted: No
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Piryani AK, Kilari S, Takahashi E, DeMartino RR, Mandrekar J, Dietz AB, Misra S. Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial). Kidney360. 2021 Sep 28;2(12):1945-1952. doi: 10.34067/KID.0005182021. eCollection 2021 Dec 30.
PubMed 35419530

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease (ESRD) trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Phase I, Open Label, Randomized Study of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure
ClinicalTrials.gov ID: NCT02808208
Acronym / sponsor ID: 15-009053
Conditions: End Stage Renal Disease (ESRD), Vascular Access Complication
Phase: Phase 1
Study type: Interventional
Recruitment status: Active, not recruiting
Enrolment: 74 participants (estimated)
Lead sponsor: Mayo ClinicUniversity, hospital or other
Study start: 7 Jun 2017 (actual)
Primary completion: Dec 2026 (estimated)
Study completion: Dec 2026 (estimated)
First posted: 21 Jun 2016 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 5

Arm	Type	Receives
Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula	Experimental	Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)
No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula	No intervention	–Patients receive standard of care.
Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula	Experimental	Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF
AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula	Experimental	Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF
Placebo treatment in brachiobasilic arteriovenous fistula	Placebo comparator	Drug: PlaceboSubjects will receive placebo at first and second stage of BBF

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (4 listed)

Patient between 18 and 85 years old
Patient currently on hemodialysis or pre-dialysis and planned 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

Key exclusion criteria (7 listed)

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
Pregnancy or breast feeding
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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)A single topical application of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period.	Biological	Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula, Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula
Placebo5-mL of Lactated Ringers solution topical application to the surface of the outflow vein (right next to the fistula) over a five-minute period.	Drug	Placebo treatment in brachiobasilic arteriovenous fistula
Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)Two topical applications of mesenchymal stem cells derived from own fat biopsy to the surface of the outflow vein (right next to the fistula) over a five-minute period at stage one and two of fistula surgery	Biological	AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula

Primary outcome

Hemodialysis outflow vein diameter
Time frame: Baseline to 12 months after AVF creation
Diameter of outflow vein by ultrasound

1 secondary outcome

Hemodialysis AVF Blood flow
Time frame: Baseline to 12 months after AVF creation

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
Derived from this study: PubMed 35419530Piryani AK, Kilari S, Takahashi E, DeMartino RR, Mandrekar J, Dietz AB, Misra S. Rationale and Trial Design of MesEnchymal Stem Cell Trial in Preventing Venous Stenosis of Hemodialysis Vascular Access Arteriovenous Fistula (MEST AVF Trial). Kidney360. 2021 Sep 28;2(12):1945-1952. doi: 10.34067/KID.0005182021. eCollection 2021 Dec 30.
Mayo Clinic Clinical TrialsLink provided by the sponsor.
Individual participant dataSharing planned: No

Related trials for End Stage Renal Disease (ESRD)

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
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Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Sanjay Misra, M.D. principal investigator

Mayo Clinic

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hemodialysis outflow vein diameter (time frame: Baseline to 12 months after AVF creation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02808208, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.