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| ID | Type | Description | Link |
|---|---|---|---|
| Nr. 04-0211 |
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This comparative, multicentre, randomised clinical trial is designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the non-surgical treatment of complex perianal fistula.
Comparative, multicentre, randomised clinical trial, designed with two parallel groups that will follow a treatment either with an autologous implant of ASCs (Adipose Derived Stem Cells) and fibrin glue (tissue adhesive material) or with fibrin glue alone for the NON-SURGICAL treatment of complex perianal fistula. The closure/healing of the fistula will be evaluated periodically, and it will be considered completely closed if there is no suppuration from the external orifice and re-epithelialisation can be observed at 8 weeks after the administration of the randomised therapy.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-surgical autologous implant of ASCs | Procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Complete closure at week 8 (defined as no suppuration from the external orifice and re-epithelization) |
| Measure | Description | Time Frame |
|---|---|---|
| No fistula recurrence after 1 year follow-up |
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Inclusion Criteria:
Patients of both sexes older than 18 years of age.
Patients with a complex perianal fistula pathology which we define as the subjects that fulfil some of the following conditions:
Patients from whom written informed consent has been obtained for them to participate in the study prior to performing any procedure described in the study.
Patients that have already been subjected to a colonoscopy within a period of up to 6 months prior to the study.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Damian Garcia-Olmo, Prof. | Cellerix | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cellerix Sl | Tres Cantos | Madrid | 28760 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12756590 | Result | Garcia-Olmo D, Garcia-Arranz M, Garcia LG, Cuellar ES, Blanco IF, Prianes LA, Montes JA, Pinto FL, Marcos DH, Garcia-Sancho L. Autologous stem cell transplantation for treatment of rectovaginal fistula in perianal Crohn's disease: a new cell-based therapy. Int J Colorectal Dis. 2003 Sep;18(5):451-4. doi: 10.1007/s00384-003-0490-3. Epub 2003 May 20. |
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| ID | Term |
|---|---|
| D012003 | Rectal Fistula |
| D005402 | Fistula |
| ID | Term |
|---|---|
| D007412 | Intestinal Fistula |
| D016154 | Digestive System Fistula |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| D005767 | Gastrointestinal Diseases |
| D012002 | Rectal Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |