End Stage Renal DiseasePhase 1NCT04392206
AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
A Phase 1 study testing Adipose Derived Mesenchymal Stem Cells in people with End Stage Renal Disease, run by Houssam Farres, M.D. at 1 site in United States.
Trial summary
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Adipose Derived Mesenchymal Stem Cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 15 May 2020to Jun 2027
- 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 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.
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
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mayo Clinic in Florida
Jacksonville, Florida, 32224
Mauricia Buchanan, 904-953-2077, Buchanan.Mauricia@mayo.edu
About this study
Official title: A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
- Conditions
- End Stage Renal Disease
- Being tested
- Adipose Derived Mesenchymal Stem Cells
- 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.
Adipose Derived Mesenchymal Stem CellsDrug
Also called AMSC
The dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution
| Study group | Role | What they receive |
|---|---|---|
| Adipose Derived Mesenchymal Stem Cells | Experimental | Subjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment. Receives: Drug: Adipose Derived Mesenchymal Stem Cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events
Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2020
- Study start15 May 2020
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Houssam Farres, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Houssam Farres, M.D., Mayo Clinic
- Investigators
- Houssam Farres, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04392206
- Sponsor's protocol ID
- 19-007203
- Status last verified
- Jul 2026
- First submitted
- 14 May 2020
- Last updated
- 10 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses
- ClinicalTrials.gov ID
- NCT04392206
- Acronym / sponsor ID
- 19-007203
- Conditions
- End Stage Renal Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Houssam Farres, M.D.University, hospital or other
- Study start
- 15 May 2020 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 18 May 2020 (actual)
- 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.
Researchers are evaluating the safety of allogeneic Adipose Derived Mesenchymal Stem Cells (AMSC) use during hemodialysis arteriovenous fistula and arterial bypass creation and its efficacy on improving access maturation and primary anastomotic patency.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adipose Derived Mesenchymal Stem Cells | Experimental | Drug: Adipose Derived Mesenchymal Stem CellsSubjects diagnosed with End Stage Renal Disease (ESRD) and are currently on hemodialysis therapy with planned creation of a new upper extremity arteriovenous fistula will receive Adipose Derived Mesenchymal Stem Cells treatment. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 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
- 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.
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 |
|---|---|---|
| Adipose Derived Mesenchymal Stem CellsAlso: AMSCThe dose will be specifically tailored to each subject's vascular anatomy determined by the surgeon through ultrasound measurements. Approximately 3-5 million cells in 5ml Ringer Lactate (RL) Solution | Drug | Adipose Derived Mesenchymal Stem Cells |
Primary outcome
Number of participants with treatment-related adverse events
Time frame: 12 months
Evaluate the safety of AMSC administration by assessing the number of participants to experience an adverse event as defined by inflammation, infection (local or systemic), aneurysm formation, clinically significant increase or decrease in blood flow or thrombosis formation as evaluated through physical exam and ultrasound.
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 10 Jul 2026.
- Individual participant dataSharing planned: No
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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.
Houssam Farres, MD 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?
A Phase 1 study testing Adipose Derived Mesenchymal Stem Cells in people with End Stage Renal Disease, run by Houssam Farres, M.D. at 1 site in United States.
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 5 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 10 Jul 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. 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?
Contact Reagan Dukes ((904) 953-2077, Dukes.Reagan@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with treatment-related adverse events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Jul 2026.