AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

End Stage Renal Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04392206
• Other study ID #: 19-007203
• Status: Recruiting
• Phase: Phase 1
• Start date: May 15, 2020
• Est. completion date: June 2025

Study information

• Verified date: August 2023
• Source: Mayo Clinic
• Contact: Reagan Dukes
• Phone: (904) 953-2077
• Email: Dukes.Reagan[@]mayo.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: June 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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)

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

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

Locations

Country	Name	City	State
United States	Mayo Clinic in Florida	Jacksonville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Albert Hakaim

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 months

External Links

•   Mayo Clinic Clinical Trials