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Treatment of Perianal Disease Using Adipose-derived Stem Cells

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ClinicalTrials.gov Identifier: NCT03913572
Recruitment Status : Recruiting
First Posted : April 12, 2019
Last Update Posted : April 15, 2019
Sponsor:
Information provided by (Responsible Party):
Samuel.Eisenstein, University of California, San Diego

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.

Condition or disease Intervention/treatment
Perianal Fistula Crohn Disease Procedure: Injection of adipose-derived stem cells into perianal fistula

Detailed Description:

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.

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Study Type : Observational
Estimated Enrollment : 25 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Treatment of Perianal Disease Using Adipose-derived Stem Cells
Actual Study Start Date : September 27, 2018
Estimated Primary Completion Date : September 26, 2019
Estimated Study Completion Date : October 26, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fistulas

Group/Cohort Intervention/treatment
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
Procedure: 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.

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



Primary Outcome Measures :
  1. Improvement in perianal disease after the procedure [ Time Frame: 4 months ]
    Patients will have routine post-operative follow up in with a colorectal surgeon and/or their clinical Nurse Practitioner 2-4 weeks following the procedure in colorectal surgery clinic. At that appointment, the timing of additional postoperative appointments or procedures will be determined. Clinical data and status of the disease will be documented by the attending surgeon and subsequently collected from the medical record. Fistula healing will be assessed clinically 3 months after the procedure has been performed. The patient will be asked to complete the Perianal Disease Activity Index (PDAI)questionnaire both prior to intervention as well as at a post-operative appointment 3 months following the procedure to asses for improvement of symptoms. The PDAI is a validated instrument to assess the severity of perianal disease . We will also perform MRIs prior to repair and after to confirm resolution of abscess cavities and fistulae.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patient's will be identified by colorectal surgeons as those with perianal disease that may benefit from the procedure above. The patients must be able to give consent for the study and complete the Perianal Crohn's Disease Activity Index in English, qualify medically for the surgical procedure, and agree to undergo treatment of perianal disease with injection of lipoaspirate.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03913572


Contacts
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Contact: Samuel Eisenstein, MD 2035602213 seisenstein@ucsd.edu
Contact: Sarah Stringfield, MD 9203191697 sbstringfield@gmail.com

Locations
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United States, California
University of California San Diego Recruiting
San Diego, California, United States, 92037
Contact: Samuel Eisenstein, MD    203-560-2213    seisenstein@ucsd.edu   
Contact: Sarah Stringfield, MD    9203191697    sbstringfield@gmail.com   
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Samuel Eisenstein, MD University of California, San Diego

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Responsible Party: Samuel.Eisenstein, Prinicipal Investigator, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03913572     History of Changes
Other Study ID Numbers: 180652
First Posted: April 12, 2019    Key Record Dates
Last Update Posted: April 15, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Crohn Disease
Fistula
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Pathological Conditions, Anatomical