Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) in Reducing Hemodialysis Arteriovenous Fistula Failure

Mayo Clinic

Status and phase: Active, not recruiting; Phase 1

Conditions: Vascular Access Complication; End Stage Renal Disease (ESRD)

Treatments: Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC); Drug: Placebo; Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)

Study type: Interventional

Funder types: Other

Identifiers

NCT02808208

15-009053

Details and patient eligibility

About

The aim of this phase 1 study is to determine the role of autologous adipose derived mesenchymal stem cells in the reduction of hemodialysis arteriovenous fistula failure when applied during the time of surgical creation.

Enrollment: 74 estimated patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

• Patient between 18 and 85 years old
• Patient currently on hemodialysis or pre-dialysis and planned 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

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
• Pregnancy or breast feeding
• 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
• Employees of the sponsor or patients who are employees or relatives of the investigator
• History of failed organ transplant on immunosuppression

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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74 participants in 5 patient groups, including a placebo group

Single dose AMSC treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula

Experimental group

Description:

Subjects who receive a radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC)

Treatment:

Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)

No Treatment in Radiocephalic (RCF)or brachiocepahlic (BCF) arteriovenous fistula

No Intervention group

Description:

Patients receive standard of care.

Single dose AMSC treatment at first stage of brachiobasilic arteriovenous fistula

Experimental group

Description:

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive a single dose of Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at time of first stage of BBF

Treatment:

Biological: Single Application of Adipose Derived Mesenchymal Stem Cells (AMSC)

AMSC treatment at first and second stage of brachiobasilic arteriovenous fistula

Experimental group

Description:

Subjects who receive a brachiobasilic arteriovenous fistula (BBF) through standard of care procedure for dialysis, will receive Autologous Adipose Derived Mesenchymal Stem Cells (AMSC) at first and second stage of BBF

Treatment:

Biological: Two Applications of Adipose Derived Mesenchymal Stem Cells (AMSC)

Placebo treatment in brachiobasilic arteriovenous fistula

Placebo Comparator group

Description:

Subjects will receive placebo at first and second stage of BBF

Treatment:

Drug: Placebo