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Recruiting NCT04392206

AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Phase I Interventional End Stage Renal Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Adipose Derived Mesenchymal Stem Cells.
Who it may be relevant to
Registry conditions: End Stage Renal Disease. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Interventions

  • Drug Adipose Derived Mesenchymal Stem Cells
    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

Primary outcome measures

  • Number of participants with treatment-related adverse events [Time frame: 12 months]

Eligibility criteria

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Treatment

Study locations

United States · 1 center
  • Mayo Clinic in Florida — Jacksonville

Identifiers

NCT: NCT04392206 · 19-007203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗