Perianal FistulaNCT03913572
Treatment of Perianal Disease Using Adipose-derived Stem Cells
An observational study of Perianal Fistula and Crohn Disease, run by University of California, San Diego at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perianal Fistula, Crohn Disease
- What is being tested?
- Injection of adipose-derived stem cells into perianal fistula
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Sep 2018to 26 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult men and women, age 18 years of age
- Diagnosis of perianal disease with tissue defect or chronic wound
- Underwent, or candidate for, surgery for perianal disease with colorectal surgery attending at UCSD
- Any ethnic background
- Any health status
- Minimum of 30 days postoperative follow-up
Who cannot join
- Pregnant women
- Children less than 18 years old
- Prisoners
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of California San Diego
San Diego, California, 92037
Samuel Eisenstein, MD, 203-560-2213, seisenstein@ucsd.edu
Sarah Stringfield, MD, 9203191697, sbstringfield@gmail.com
About this study
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.
Read the detailed description
Specific Aims:
- 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.
- Conditions
- Perianal Fistula, Crohn Disease
- Being tested
- Injection of adipose-derived stem cells into perianal fistula
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection of adipose-derived stem cells into perianal fistulaProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: Injection of adipose-derived stem cells into perianal fistula | |
| Retrospective cohort | Patients that have undergone treatment of perianal disease without use of adipose-derived stem cell injection. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start27 Sep 2018
- Primary completion26 Jun 2021 (estimated)
- Study completion26 Jul 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perianal FistulaStudies of the same condition, open and under way.
- More trials run by University of California, San DiegoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, San Diego
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samuel.Eisenstein, University of California, San Diego
- Investigators
- Samuel Eisenstein, MD, Principal investigator, University of California, San Diego
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913572
- Sponsor's protocol ID
- 180652
- Status last verified
- Apr 2021
- First submitted
- 27 Feb 2019
- Last updated
- 27 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Perianal Disease Using Adipose-derived Stem Cells
- ClinicalTrials.gov ID
- NCT03913572
- Acronym / sponsor ID
- 180652
- Conditions
- Perianal Fistula, Crohn Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of California, San DiegoUniversity, hospital or other
- Study start
- 27 Sep 2018 (actual)
- Primary completion
- 26 Jun 2021 (estimated)
- Study completion
- 26 Jul 2021 (estimated)
- First posted
- 12 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Specific Aims:
- 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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| REVOLVE | – | Procedure: Injection of adipose-derived stem cells into perianal fistulaPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- Adult men and women, age 18 years of age
- Diagnosis of perianal disease with tissue defect or chronic wound
- Underwent, or candidate for, surgery for perianal disease with colorectal surgery attending at UCSD
- Any ethnic background
- Any health status
Key exclusion criteria (3 listed)
- Pregnant women
- Children less than 18 years old
- Prisoners
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Injection of adipose-derived stem cells into perianal fistulaThe 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. | Procedure or surgery | REVOLVE |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Samuel Eisenstein, MD principal investigator
University of California, San Diego
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Perianal Fistula and Crohn Disease, run by University of California, San Diego at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samuel Eisenstein, MD (2035602213, seisenstein@ucsd.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in perianal disease after the procedure (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Apr 2021.