HOLLYWOOD, Fla., Jan. 29, 2019 /PRNewswire/ -- The International Symposium on Endovascular Therapy (ISET), today announced that more than 20 highly anticipated research studies, including the first-time presentation of data from a promising clinical research trial, were presented during this year's meeting, January 27-30 at The Diplomat Hotel in Hollywood, Florida.
Below is a summary from today's first-time presentation of clinical trial results from the First in Human Stem Cell Trial for Hemodialysis AVF study:
First in Human Stem Cell Trial for Hemodialysis AVF
Presenter: Sanjay Misra, MD, FAHA, FSIR, Mayo Clinic, Rochester, Minnesota
Presentation: Tuesday, January 29, 2019
This trial presents the preliminary results and trial design of a phase 1 clinical trial using autologous adipose derived mesenchymal stem cells (AMSCs) for increasing maturation and preventing venous stenosis formation in arteriovenous fistulas used for hemodialysis.
This was a phase I, single center, prospective, blinded, randomized trial of periadventitial delivery of autologous AMSCs or no cells to the outflow vein of arteriovenous fistula (AVF) at the time of creation. The amount of cells delivered was based on the surface area of the vessel using the following calculation: [(2π)(radius in cm)(5cm) x (500,000 cells per cm2]. There were 16 patients (11M, 5F) in this trial with an average age of 64.3 ± 8.8 years.
Patients underwent follow-up using ultrasound to assess vascular remodeling of the AVF at 1, 2, 3, 6, and 12 months after AVF placement. In addition, clinical and dialysis assessment of the AVF will be performed.
All patients were hypertensive, 10 had history of diabetes mellitus, 5 were on hemodialysis, 6 had a history of coronary artery disease, and 11 had dyslipidemia. The average BMI was 37.99. There was no difference between groups. Nine (9) patients received BA-CV fistulas and 7 received RA- CV fistulas. Average follow-up was 8.73 months; 9 patients completed 1-year follow-up. There were no adverse events related to stem cell delivery. At 1 month, the maturation rate for RCV fistula was 100% for stem cell patients versus 66% for the control; in the BCV group, the maturation rate was 100% for both stem cells (n=4) and controls (n=4). At last follow-up, 3 patients in the control group (1 BCF, 2RCF) underwent 5 fistulograms with 4 PTAs of the cannulation zone. One patient in the stem cell group (BCF) had a fistulogram with PTA of the cannulation zone. There were no adverse events related to stem cell delivery.
There have been no safety issues with respect to cellular delivery. This prospective phase 1 trial continues to enroll patients and a future study is being planned to help determine the efficacy of this therapy. A possible future direction of this work could be its use in conjunction with angioplasty for stenotic AVF.
Created in 1989 by Barry T. Katzen, MD, the founder and chief medical executive of Miami Cardiac & Vascular Institute (MCVI), ISET is the premier educational forum for physicians and allied health professionals who treat patients with peripheral, cardiac, and neurovascular disease. The annual meeting, which features globally recognized faculty who are experts in their field, delivers practical and hands-on education focused on the latest endovascular approaches, techniques, and technologies. HMP, a leader in healthcare events and education, acquired the meeting in 2016.
To view all research abstracts from ISET 2019, please visit:
To learn more about ISET 2019, visit iset.org.
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