Anal FistulaPhase 1/2REP-PAFNCT06303752
Tissue Therapy of Transsphincteric Anal Fistula
A Phase 1/2 study testing ADRC injection and ADRC001 injection in people with Anal Fistula, run by University of Southern Denmark at 1 site in Denmark.
Trial summary
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anal Fistula
- What is being tested?
- ADRC injection and ADRC001 injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteDenmark
- Study dates
- 9 Oct 2024to 8 Oct 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
- able to communicate with Danish language
- able to provide informed consent
- having address in the region of southern Denmark during the study
Who cannot join
- Signs of suppuration/cavitation around the fistula
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
- Immunosuppression (due to clinical condition or medical therapy)
Show all 13Show fewer
- Malignancy within 5 years
- Previous radiotherapy of the abdomen and pelvis
- BMI under 18.5
- Allergy against the antibiotics: Penicillin and streptomycin.
- Coagulopathy
- Pregnancy and lactation (positive HCG (human chorionic gonadotropin) test)
- Verified syphilis, HIV, or hepatitis on screening test
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Denmark1 site, 1 recruiting
- Recruiting
Odense University Hospital
Odense, 5000
Karam M Sørensen, Ph.D, +4565415190, ouh.a.forskningsenheden@rsyd.dk
Tina D Hansen, +4565415190, ouh.a.forskningsenheden@rsyd.dk
About this study
Official title: Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
This clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Read the detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.
- Conditions
- Anal Fistula
- Being tested
- ADRC injection, ADRC001 injection
- Keywords
- anal fistula, stem cells, ADRC
- Medical subject headings
- Rectal Fistula
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADRC injectionDrug
Also called Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate
Allocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection.
ADRC001 injectionDrug
Also called Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirate
Allocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection.
| Study group | Role | What they receive |
|---|---|---|
| Autologous ADRC | Experimental | Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection. Receives: Drug: ADRC injection |
| allogenic ADRC001 | Experimental | Allocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection. Receives: Drug: ADRC001 injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Healing rate (percentage)
Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
Measured: at 6 and 12 months follow-up
Secondary outcomes (7)
QoL
functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire.
Measured: at12 months follow-up.
Fecal Incontinence
functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score.
Measured: at12 months follow-up.
Risk factors for recurrence of fistula.
Risk factors for recurrence of fistula including demography, prevoius surgery for fistula, disease duration and treatment arm.
Measured: at12 months follow-up.
Radiological healing.
Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
Measured: at12 months follow-up.
Treatment efficacy.
comparison of the healing rate of the fistula between patients receiving ADRC and patients receiving ADRC001 (autologous vs. allogenic cells)
Measured: at12 months follow-up.
Cellular composition
Definition of the cellular compisition of the ADRC and ADRC001 regarding cellular surface markers (CD14, CD31, CD34, CD45, CD73, CD90, CD105, CD235a, HLA-ABC og HLA-DR) using flowcytometry.
Measured: at 3 months follow-up.
Transplantation-related alloantibodies
Registration of the number of patients developing serum alloantibodies specific to donor genotypes, by assessment of anti-HLA (class I and II).
Measured: at12 months follow-up.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start9 Oct 2024
- Primary completion8 Oct 2027 (estimated)
- Study completion8 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anal FistulaStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Karam Matlub Sørensen, PhD, University of Southern Denmark
- Investigators
- Karam M Sørensen, Principal investigator, OUH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06303752
- Sponsor's protocol ID
- 260-2021-NQ
- Other IDs
- 2022-502659-73
- Acronym
- REP-PAF
- Status last verified
- Nov 2024
- First submitted
- 25 Feb 2024
- Last updated
- 5 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 5 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Repairing Peri-Anal Fistulas With Regenerative Cell Therapeutics
- ClinicalTrials.gov ID
- NCT06303752
- Acronym / sponsor ID
- REP-PAF / 260-2021-NQ
- Conditions
- Anal Fistula
- Keywords
- anal fistula, stem cells, ADRC
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 9 Oct 2024 (actual)
- Primary completion
- 8 Oct 2027 (estimated)
- Study completion
- 8 Oct 2028 (estimated)
- First posted
- 12 Mar 2024 (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 clinical study aims to evaluate the outcome of the treatment of complex perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Detailed description
After being informed about the study and potential risks, all patients giving written informed consent will undergo screening serology and preoperative work-up to determine eligibility for study entery. Patients who meet the eligibility requirements will be treated for their fistulas by combined minor surgical debridement of the fistula tract and closure of the internal orifice as well as liposuction from the abdominal wall. Regenerative cells- enriched lipoaspirate will be injected around the entire length of the fistula tract. The first five patients will receive their own regenerative cells and act as donors for the next included patients, but they will not be included in the final analysis. The rest of the included patients (70) will be randomized in double-blinded manner (participant and investigator) in a 1:1 ratio to either recieve own regenerative cells (ADRC Adipose-Derived Regeneative Cells) or donated cultured regenerative cells (ADRC001). All included patients will be scheduled for follow-up at 3, 6 and 12 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous ADRC | Experimental | Drug: ADRC injectionAllocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection. |
| allogenic ADRC001 | Experimental | Drug: ADRC001 injectionAllocated patients will be treated for the fistula by combined surgical debridement of the fistula tract, closure of the internal orifice and injection of 30 ml lipoaspirate around the entire length of the fistula tract. Lipoaspirate will be harvested from the anterior abdominal wall under the same operation. Two hours later, the patient will receive injection of 5 ml suspension including 30 million cultured allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Adult patients (>= 18years) with complex anal fistula (high transsphincteric or suprasphincteric), with involvement of more 30% of the anal sphincter referred to the surgical department at Odense University Hospital for treatment, and who are:
- able to communicate with Danish language
- able to provide informed consent
- having address in the region of southern Denmark during the study
Key exclusion criteria (13 listed)
- Signs of suppuration/cavitation around the fistula
- Simple or low anal fistula, which can be treated by simple surgical incision
- Ano-vaginal and recto-vaginal fistula
- The presence of more than one fistula tract, more than two external orifices or more than one internal orifice
- Inflammatory Bowel Disease
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 |
|---|---|---|
| ADRC injectionAlso: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirateAllocated patients will receive injection of 5 ml suspension including 30 million autologous adipose-derived regenerative cells ADRC and injected at the same site of the lipoaspirate injection. | Drug | Autologous ADRC |
| ADRC001 injectionAlso: Liposuction, Surgical debridement of fistula tract and closure of internal orifice, Injection of lipoaspirateAllocated patients will receive injection of 5 ml suspension including 30 million allogenic adipose-derived regenerative cells ADRC001 and injected at the same site of the lipoaspirate injection. | Drug | allogenic ADRC001 |
Primary outcome
Healing rate (percentage)
Time frame: at 6 and 12 months follow-up
Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
7 secondary outcomes
QoL
Time frame: at12 months follow-up.
Fecal Incontinence
Time frame: at12 months follow-up.
Risk factors for recurrence of fistula.
Time frame: at12 months follow-up.
Radiological healing.
Time frame: at12 months follow-up.
Treatment efficacy.
Time frame: at12 months follow-up.
Cellular composition
Time frame: at 3 months follow-up.
Transplantation-related alloantibodies
Time frame: at12 months follow-up.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2024.
- 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.
Karam M Sørensen principal investigator
OUH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing ADRC injection and ADRC001 injection in people with Anal Fistula, run by University of Southern Denmark at 1 site in Denmark.
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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 5 Nov 2024. 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 Denmark. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Karam M Sørensen, Ph.D (+4565415190, ouh.a.forskningsenheden@rsyd.dk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Healing rate (percentage) (time frame: at 6 and 12 months follow-up). 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 5 Nov 2024.