Recruiting

Adipose-derived Stem Cells

Sponsor:

UCLA

Code:

NCT03913572

Conditions

Perianal Fistula

Crohn Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Injection of adipose-derived stem cells into perianal fistula

Study Details

Brief 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.

Conditions

Perianal Fistula

Crohn Disease

Study ID

NCT03913572

Start date

Sep 27, 2018

Status verified date

Apr, 2021

Completion date

Jul 26, 2021

Anticipated

Primary completion date

Jun 26, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Arms

REVOLVE

Patients that have agreed to be prospectively enrolled in the study and undergo Injection of adipose-derived stem cells into perianal fistula with the REVOLVE system

Retrospective cohort

Patients that have undergone treatment of perianal disease without use of adipose-derived stem cell injection.

Interventions

Injection of adipose-derived stem cells into perianal fistula

The plastic surgery team will perform fat graft harvest. Tumescent solution will be infiltrated into the area of liposuction, generally the abdomen, flanks, or thighs. Approximately a00ml of liposuction aspirate will be retrieved. It will be washed and condensed down to about 5-25 ml of good-quality fat graft using the REVOLVE System by Acelity. This will then be loaded into a syringe fitted with an injection cannula. The colorectal surgeon will perform an exam under anesthesia and determine if any additional procedure such as ligation of fistula tract, fistulotomy, endorectal advancement flap, or seton placement/exchange is needed. Severity of disease at time of surgery will be recorded by the attending surgeon. Following any indicated procedure, the lipoaspirate will be injected into the soft tissues around the fistula tract.

Primary outcome measure

  • Improvement in perianal disease after the procedure [ Time Frame: 4 months ]

Central Contacts and Locations

Central contacts

Samuel Eisenstein, MD

2035602213seisenstein@ucsd.edu

Sarah Stringfield, MD

9203191697sbstringfield@gmail.com

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Samuel Eisenstein, MD

203-560-2213seisenstein@ucsd.edu

Sarah Stringfield, MD

9203191697sbstringfield@gmail.com

More Information

Sponsor

University of California, San Diego

Last update posted

Apr 27, 2021

Last verified

Apr, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of California, San Diego on 2021-04-27.