Summary

for people ages 18 years and up (full criteria)
at San Diego, California
study started
estimated completion
Samuel Eisenstein, MD

Description

Summary

This study will compare healing and surgical outcomes in patients with chronic perianal disease treated with Adipose-derived Stem Cells (ASCs) to outcomes in patients treated in traditional surgical techniques without ASCs. The study will perform retrospective medical record analysis to clinically characterize patients that have undergone these surgical procedures and compare follow-up data and disease status to determine efficacy of treatment with ASCs compared to similar treatments without the use of ASCs. This will help determine overall efficacy of the treatment as well as determine patient characteristics that may predict treatment success. The study will also prospectively recruit patients with perianal disease that are planning to receive treatment with ASCs, and analyze their outcomes in the same way. Medical record review of outcomes in patients with perianal disease that received treatment with ASCs compared to those that did not will determine efficacy of this procedure.

Details

Specific Aims:

  1. Conduct a retrospective review of health information data from patients who have undergone surgery with a colorectal surgery attending at the University of California San Diego, including surgical treatment of perianal fistulas or other chronic perianal diseases, with or without injection of lipoaspirate containing adipose-derived stem cells. Patient data from December 2013 to April 1, 2018, will be obtained, with parameters including date of birth, sex, date of surgery, medical history, surgical history, laboratory values, perioperative data such as blood loss, length of surgery, operative complications, readmissions, and long-term complications and status of disease.
  2. Conduct an observational study comparing outcomes of patients that plan to undergo treatment of perianal disease using ASCs compared to those that do not use ASCs. Patients identified as candidates for the procedure by the colorectal surgeons and are planning to undergo the procedure will give informed consent and be recruited into the study. Participants will undergo isolation of ASCs using the REVOLVE ™ System and injection of ASCs into perianal wounds. Clinical data will be analyzed to determine efficacy of the procedure as a means of treating perianal disease.
  3. Use the above data to clinically characterize patients that undergo this surgical procedure and what patient characteristics may determine outcomes. Comparing follow-up data and disease status will determine efficacy of treatment with adipose-derived stem cells compared to similar treatments without the use of stem cells.

Keywords

Perianal Fistula Crohn Disease Fistula Injection of adipose-derived stem cells into perianal fistula REVOLVE

Eligibility

You can join if…

Open to people ages 18 years and up

  1. Adult men and women, age 18 years of age
  2. Diagnosis of perianal disease with tissue defect or chronic wound
  3. Underwent, or candidate for, surgery for perianal disease with colorectal surgery attending at UCSD
  4. Any ethnic background
  5. Any health status
  6. Minimum of 30 days postoperative follow-up

You CAN'T join if...

  1. Pregnant women
  2. Children less than 18 years old
  3. Prisoners

Location

  • University of California San Diego accepting new patients
    San Diego California 92037 United States

Lead Scientist

  • Samuel Eisenstein, MD
    Assistant Clinical Professor, Surgery. Authored (or co-authored) 26 research publications. Research interests: surgical outcomes · robotic surgery · laparoscopic surgery · Minimally invasive surgery · Fecal incontinence · Anal Fistula · Diverticulitis · Rectal Cancer · Colon Cancer · Ulcerative Colitis · Crohn's Disease · Inflammatory Bowel Disease · Colon and rectal Surgery

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Diego
ID
NCT03913572
Study Type
Observational
Last Updated