Overview
Sponsor-declared trial summary
Phase
Phase I and Phase II (Integrated) - First administration to humans
Status
Ongoing, recruiting
Participants planned
75
Countries
1
Sites
1
Crypto-glandular perianal fistula
This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Key facts
- Sponsor
- Odense University Hospital
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Digestive System Diseases [C06]
- Trial duration
- 9 Oct 2024 → ongoing
- Decision date (initial)
- 2024-02-23
- Transition trial
- No
- Low-intervention
- No
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Efficacy, Therapy
This clinical study aims to evaluate the outcome of the treatment of complex crypto-glandular perianal fistulas (PAF) by the combination of minimal surgical debridement with regenerative cellular therapeutics.
Conditions and MedDRA coding
Crypto-glandular perianal fistula
Regulatory references
- Plan to share IPD
- No
| EU CT number | Title | Sponsor |
|---|---|---|
| 2022-502659-73-00 | Repairing Peri-Anal Fistulas with regenerative cell therapeutics (REP-PAF) | Odense University Hospital |
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 4
- Adult patients (>= 18years) with complex PAF (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
- and who are able to communicate with Danish language
- and who are having address in the region of southern Denmark during the study
Exclusion criteria 13
- 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)
- 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 test)
- Verified syphilis, HIV, or hepatitis on screening test
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- The healing rate (percentage) after observation time of six and twelve months. Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation.
Secondary endpoints 4
- Functional outcome regarding quality of life and anal continence, measured by Short Form SF-36 Rand questionnaire and Wexner Fecal Incontinence score respectively
- The risk factors for recurrence of PAF
- The radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging.
- A comparison of autologous vs. allogenic Adipose-Derived Regenerative Cells (ADRCs) regarding cell characterization, immune responses, and efficacy.
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
Culture expanded Adipose Derived Regenerative Cells, ADRC001
PRD10512270 · Product
- Active substance
- ADRC001
- Other product name
- ADRC001
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 30 million organisms/ml million organisms/millilitre
- Max total dose
- 30 million organisms/ml million organisms/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OUPHET
- Paediatric formulation
- No
- Orphan designation
- No
Adipose Derived Regenerative Cells ADRC/SVF
PRD10505824 · Product
- Active substance
- Adrc
- Other product name
- ADRC
- Pharmaceutical form
- SUSPENSION FOR INJECTION
- Route of administration
- INJECTABLE SOLUTION
- Max daily dose
- 30 million organisms/ml million organisms/millilitre
- Max total dose
- 30 million organisms/ml million organisms/millilitre
- Max treatment duration
- 1 Day(s)
- Authorisation status
- Not Authorised
- MA holder
- OUPHET
- Paediatric formulation
- No
- Orphan designation
- No
Auxiliary 2
Zinnat 500 mg film-coated tablets
PRD9901829 · Product
- Active substance
- Cefuroxime
- Pharmaceutical form
- FILM-COATED TABLET
- Route of administration
- ORAL
- Max daily dose
- 1000 mg milligram(s)
- Max total dose
- 7000 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- J01DC02 — -
- Marketing authorisation
- PA23311/003/004
- MA holder
- SANDOZ PHARMACEUTICALS D.D.
- MA country
- Ireland
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
PRD8609890 · Product
- Active substance
- Metronidazole
- Pharmaceutical form
- TABLET
- Route of administration
- ORAL
- Max daily dose
- 1500 mg milligram(s)
- Max total dose
- 10500 mg milligram(s)
- Max treatment duration
- 1 Week(s)
- Authorisation status
- Authorised
- ATC code
- P01AB01 — METRONIDAZOLE
- Marketing authorisation
- PL 20075/0694
- MA holder
- ACCORD HEALTHCARE LIMITED
- MA country
- XI
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Odense University Hospital
- Sponsor organisation
- Odense University Hospital
- Address
- J B Winsloews Vej 4
- City
- Odense C
- Postcode
- 5000
- Country
- Denmark
Scientific contact point
- Organisation
- Odense University Hospital
- Contact name
- Research Unit, Department of Surgery
Public contact point
- Organisation
- Odense University Hospital
- Contact name
- Research Unit, Department of Surgery
Third parties 1
| Organisation | City, country | Duties |
|---|---|---|
| Odense University Hospital ORG-100007716
|
Odense C, Denmark | On site monitoring, Code 10, E-data capture, Code 8, Code 9 |
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Denmark | Ongoing, recruiting | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Country notifications
Trial-start, recruitment-start, end and early-termination notifications submitted per Member State
| Country | Trial start | Trial end | Recruitment start | Recruitment end | Early termination |
|---|---|---|---|---|---|
| Denmark | 2024-10-09 | 2024-11-21 |
Results and documents
Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial
Documents 7 files
Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.
| Type | Title | Version |
|---|---|---|
| Protocol (for publication) | D1_ Protocol 2022-502659-73 | 5 |
| Protocol (for publication) | D2_SF-36-4uger | 1 |
| Protocol (for publication) | D3_ Lukkemuskelfunktion Wexner Score | 1 |
| Recruitment arrangements (for publication) | K1_ Recruitment arrangements | 2 |
| Subject information and informed consent form (for publication) | L1_ SIS and ICF adults | 3 |
| Subject information and informed consent form (for publication) | L2_rettigheder som forsgsperson i forsg med medicin | 1 |
| Synopsis of the protocol (for publication) | D1_ Protocol synopsis DK 2022-502659-73 | 1 |
Application history
4 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2023-11-18 | Denmark | Acceptable 2024-02-23
|
2024-02-23 |
| 2 | SUBSTANTIAL MODIFICATION | SM-1 | 2024-08-29 | Denmark | Acceptable 2024-09-03
|
2024-09-03 |
| 3 | SUBSTANTIAL MODIFICATION | SM-2 | 2025-05-28 | Denmark | Acceptable 2025-07-07
|
2025-07-08 |
| 4 | SUBSTANTIAL MODIFICATION | SM-3 | 2025-08-18 | Denmark | Acceptable 2025-09-19
|
2025-09-22 |