RECRUITING

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

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Conditions

End Stage Renal Disease

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

A Phase I, Open Label Study of Allogeneic Adipose Derived Mesenchymal Stem Cells in Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Quick Facts

Study Start:2020-05-15
Study Completion:2025-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04392206

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 85 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Patient between 18 and 85 years old
  2. * Patient currently planned for creation of an upper extremity AV fistula with suitable anatomy
  3. * Ability to communicate meaningfully with investigative staff, competence to give written informed consent, and ability to comply with entire study procedures
  4. * Life expectancy of at least 24 months
  5. * 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.
  1. * Malignancy or treatment for malignancy within the previous 6 months
  2. * Immunodeficiency including AIDS / HIV or Active autoimmune disease
  3. * Documented hypercoagulable state or history of 2 or more DVTs or other spontaneous intravascular thrombotic events
  4. * 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
  5. * History of failed organ transplant on immunosuppression.
  6. * Subjects with known active infection (infection which is being treated)

Contacts and Locations

Study Contact

Reagan Dukes
CONTACT
(904) 953-2077
Dukes.Reagan@mayo.edu
Mauricia Buchanan
CONTACT
(904) 953-2077
buchanan.mauricia@mayo.edu

Principal Investigator

Houssam Farres, MD
PRINCIPAL_INVESTIGATOR
Mayo Clinic

Study Locations (Sites)

Mayo Clinic in Florida
Jacksonville, Florida, 32224
United States

Collaborators and Investigators

Sponsor: Houssam Farres, M.D.

  • Houssam Farres, MD, PRINCIPAL_INVESTIGATOR, Mayo Clinic

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-05-15
Study Completion Date2025-06

Study Record Updates

Study Start Date2020-05-15
Study Completion Date2025-06

Terms related to this study

Additional Relevant MeSH Terms

  • End Stage Renal Disease