AMSC for Reducing Anastomotic Stenosis in Primary Arteriovenous Anastomoses

Houssam Farres, M.D.

Status and phase: Enrolling; Phase 1

Conditions: End Stage Renal Disease

Treatments: Drug: Adipose Derived Mesenchymal Stem Cells

Study type: Interventional

Funder types: Other

Identifiers

NCT04392206

19-007203

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Adipose Derived Mesenchymal Stem Cells

Experimental group

Description:

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.

Treatment:

Drug: Adipose Derived Mesenchymal Stem Cells