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 27, 2021
|Condition or disease||Intervention/treatment|
|Perianal Fistula Crohn Disease||Procedure: Injection of adipose-derived stem cells into perianal fistula|
- 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.
- 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.
- 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.
|Study Type :||Observational|
|Estimated Enrollment :||25 participants|
|Official Title:||Treatment of Perianal Disease Using Adipose-derived Stem Cells|
|Actual Study Start Date :||September 27, 2018|
|Estimated Primary Completion Date :||June 26, 2021|
|Estimated Study Completion Date :||July 26, 2021|
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.
Patients that have undergone treatment of perianal disease without use of adipose-derived stem cell injection.
- 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.
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
|Contact: Samuel Eisenstein, MDfirstname.lastname@example.org|
|Contact: Sarah Stringfield, MDemail@example.com|
|Principal Investigator:||Samuel Eisenstein, MD||University of California, San Diego|