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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-502659-73 | EudraCT Number |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ADRC injection | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Healing rate (percentage) | Clinical healing is defined as closure of the external opening(s), absence/cessation of discharge and swelling by palpation. | at 6 and 12 months follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| QoL | functional outcome regarding quality of life, measured by Short Form SF-36 Rand questionnaire. | at12 months follow-up. |
| Fecal Incontinence | functional outcome regarding fecal incontinence, measured by Wexner Fecal Incontinence score. |
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Inclusion criterion:
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:
Exclusion criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Karam M Sørensen, Ph.D | Contact | +4565415190 | ouh.a.forskningsenheden@rsyd.dk | |
| Tina D Hansen | Contact | +4565415190 | ouh.a.forskningsenheden@rsyd.dk |
| Name | Affiliation | Role |
|---|---|---|
| Karam M Sørensen | OUH | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Odense University Hospital | Recruiting | Odense | 5000 | Denmark |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D015187 | Lipectomy |
| ID | Term |
|---|---|
| D003357 | Cosmetic Techniques |
| D013812 | Therapeutics |
| D050110 | Bariatric Surgery |
| D049088 | Bariatrics |
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| ADRC001 injection | Drug | 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. |
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| 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. | at12 months follow-up. |
| Radiological healing. | Radiological healing, defined as no visible fistula or fluid collection more than 5 mm at MR imaging. | 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) | 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. | 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). | at12 months follow-up. |
| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D005402 | Fistula |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000073319 |
| Obesity Management |
| D013514 | Surgical Procedures, Operative |
| D019651 | Plastic Surgery Procedures |