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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.
Specific Aims:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of adipose-derived stem cells into perianal fistula | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in perianal disease after the procedure | 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. | 4 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Samuel Eisenstein, MD | Contact | 2035602213 | seisenstein@ucsd.edu | |
| Sarah Stringfield, MD | Contact | 9203191697 | sbstringfield@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Samuel Eisenstein, MD | University of California, San Diego | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California San Diego | Recruiting | San Diego | California | 92037 | United States |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | May 16, 2022 | |
| Reset | Feb 14, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| May 16, 2022 | Feb 14, 2023 |
| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D007410 | Intestinal Diseases |