Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
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.
Allocation: Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Non-surgical autologous implant of ASCs
Active, not recruiting
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT00115466
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
An abnormal anatomical passage between the INTESTINE, and another segment of the intestine or other organs. External intestinal fistula is connected to the SKIN (enterocutaneous fistula). Internal intestinal fistula can be connected to a number of organs, such as STOMACH (gastrocolic fistula), the BILIARY TRACT (cholecystoduodenal fistula), or the URINARY BLADDER of the URINARY TRACT (colovesical fistula). Risk factors include inflammatory processes, cancer, radiation treatment, and surgical misadventures (MEDICAL ERRORS).
An abnormal anatomical passage that connects the VAGINA to other organs, such as the bladder (VESICOVAGINAL FISTULA) or the rectum (RECTOVAGINAL FISTULA).
Surgical insertion of an implant to replace one or more of the ear ossicles.
Recovery of blood lost from surgical procedures for reuse by the same patient in AUTOLOGOUS BLOOD TRANSFUSIONS. It is collected during (intraoperatively) or after completion of (postoperatively) the surgical procedures.
Insertion of an implant into the bone of the mandible or maxilla. The implant has an exposed head which protrudes through the mucosa and is a prosthodontic abutment.
Anal fistula is defined as an abnormal communication between the anal canal and the perianal skin. Adipose-derived stem cells are a new therapy for the closure of these fistulas. This stud...
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