Perianal FistulaNCT05709717
Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
An observational study of Perianal Fistula and Perianal Crohn Disease, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
Trial summary
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Perianal Fistula, Perianal Crohn Disease, Anal Fissure
- What is being tested?
- Regenerative therapy with SVF-PRP to supplement perianal surgery
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 25 Jan 2023to 31 Jan 2024
- How long will I take part?
- 1 Year
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with complex perianal disease
Who may be able to join
- Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Kantonsspital Winterthur
Winterthur, 8401
Michel Adamina, MD, PD, MSc, EMBA HSG, +41522663376, michel.adamina@ksw.ch
Rebekka Sterki, +41522662040, rebekka.sterki@ksw.ch
About this study
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median \& interquartile range (IQR)
- Conditions
- Perianal Fistula, Perianal Crohn Disease, Anal Fissure, Rectovaginal Fistula, Perianal Fistula Due to Crohn's Disease
- Being tested
- Regenerative therapy with SVF-PRP to supplement perianal surgery
- Medical subject headings
- Fissure in Ano, Rectovaginal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Regenerative therapy with SVF-PRP to supplement perianal surgeryProcedure or surgery
Also called SVF-PRP
Regenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical Healing
Absence of fistula opening and discharge, well-being
Measured: 1 year
MRI healing
Absence of active fistula and abscess
Measured: 1year
Secondary outcomes (3)
Fecal continence
Vaizey score
Measured: 1 year
Quality of life (general and related to perianal diseases)
FIQoL
Measured: 1 year
Costs
Direct cost to patient, institution, and payee
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2023
- Study start25 Jan 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jan 2024 (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.
- 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
- Prospective
- Enrolment
- 50 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Kantonsspital Winterthur KSW
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michel Adamina, MD, PD, MSc, EMBA HSG, Principal investigator, Chief of Colorectal Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05709717
- Sponsor's protocol ID
- SVF-PRP
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2023
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Anonymized data could be shared upon reasonable request and pending ethical clearance
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Regenerative Therapy With Autologous Stromal Vascular Fraction Derived Mesenchymal Stem Cells and Platelet-rich Plasma to Treat Complex Perianal Diseases
- ClinicalTrials.gov ID
- NCT05709717
- Acronym / sponsor ID
- SVF-PRP
- Conditions
- Perianal Fistula, Perianal Crohn Disease, Anal Fissure, Rectovaginal Fistula, Perianal Fistula Due to Crohn's Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kantonsspital Winterthur KSWUniversity, hospital or other
- Study start
- 25 Jan 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jan 2024 (estimated)
- First posted
- 2 Feb 2023 (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.
Consecutive patients with complex anal fistula were prospectively followed for 12 months. Routine MRI was performed before and at 4 and 12 months after surgery. Continence was assessed likewise using a validated questionnaire. Fistula were drained with setons prior surgery. SVF was harvested from subcutaneous abdominal fat and PRP from peripheral blood. Distal fistulectomy to the sphincter was performed and the wound left open, while the internal orifice was closed. SVF-PRP was injected around the fistula. Patients showered their excision wound until dry. Outcomes were reported as median \& interquartile range (IQR)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with complex perianal disease
Key inclusion criteria (1 listed)
- Perianal fistula Perianal fissure Anovaginal fistula Rectovaginal fistula Perianal Crohn's disease
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| Regenerative therapy with SVF-PRP to supplement perianal surgeryAlso: SVF-PRPRegenerative therapy with autologous stromal vascular fraction derived mesenchymal stem cells and platelet-rich plasma to supplement perianal surgery | Procedure or surgery | – |
Primary outcome
Clinical Healing
Time frame: 1 year
Absence of fistula opening and discharge, well-being
MRI healing
Time frame: 1year
Absence of active fistula and abscess
3 secondary outcomes
Fecal continence
Time frame: 1 year
Quality of life (general and related to perianal diseases)
Time frame: 1 year
Costs
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Undecided. Anonymized data could be shared upon reasonable request and pending ethical clearance
Related trials for Perianal Fistula
RecruitingPhase 4
Risankizumab for Refractory Perianal Fistulizing Crohn's Disease
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Antibiotics After Incision and Drainage to Prevent Fistula Formation After First Episode of Perianal Abscess
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FiLaC and PRGF-Endoret for Multi-recurrent Cryptoglandular Perianal Fistula (PLASMA Pilot Study)
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Recruiting
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Cryptoglandular Perianal Fistula
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.
Michel Adamina, MD, PD, MSc, EMBA HSG principal investigator
Chief of Colorectal Surgery
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 Perianal Crohn Disease, run by Kantonsspital Winterthur KSW at 1 site in Switzerland.
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 1 inclusion and 1 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 2 Feb 2023. 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 Switzerland. 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 Michel Adamina, MD, PD, MSc, EMBA HSG (+41522663376, michel.adamina@ksw.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical Healing (time frame: 1 year). The study lists 2 primary outcomes in all. 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 2 Feb 2023; AzTrials last refreshed its copy on 7 Nov 2026.