Autologous Stem Cells Derived From Lipoaspirates for the Non-Surgical Treatment of Complex Perianal Fistula
Summary
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.
Description
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.
Study Design
Allocation: Randomized, Control: Historical Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Anal Fistula
Intervention
Non-surgical autologous implant of ASCs
Location
Cellerix Sl
Tres Cantos
Madrid
Spain
28760
Status
Active, not recruiting
Source
Cellerix
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00115466
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Intestinal Fistula
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).
Vaginal Fistula
An abnormal anatomical passage that connects the VAGINA to other organs, such as the bladder (VESICOVAGINAL FISTULA) or the rectum (RECTOVAGINAL FISTULA).
Ossicular Replacement
Surgical insertion of an implant to replace one or more of the ear ossicles.
Operative Blood Salvage
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.
Dental Implantation, Endosseous
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.
Clinical Trials
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...
Anal fistulae are a difficult problem to treat. The optimal treatment for fistula involving the anal sphincter is unclear. Two standardly used methods of treatment are the ligation of in...
Treatment of Crohn's Fistula Using a Porcine Intestine Submucosa Graft (Surgisis AFP)
Healing anal fistulas in Crohn's patients with an anal fistula plug.
Surgisis Anal Fistula Plug Study: An Experience in Saudi Arabia
The Surgisis Anal Fistula Plug study is a clinical trial conducted in Saudi Arabia to study the safety and effectiveness of the Surgisis AFP Plug in the treatment of chronic anal fistulas.
The purpose of this study is to determine whether the Surgisis anal fistula plug is just as effective in healing anal fistulas as compared to the advancement flap procedure.
PubMed Articles
Fistula is a representative devastating complication in Crohn's patients due to refractory to conventional therapy and high recurrence. In our phase I clinical trial, adipose tissue-derived stem cells...
Abstract Surgical treatment of high or complex anal fistulas often renders unsatisfying results. This is the report of the first successful closure of such anal fistula using a special Nitinol clip an...
The most common cause of anal fistula is anal gland sepsis, resulting in formation of anorectal abscess, particularly if the latter allowed bursting spontaneously or has been inadequately opened at op...
Treatment of fistula-in-ano with the Surgisis((R)) AFP(TM) anal fistula plug.
OBJECTIVE: Closure of the fistula tract with an anal fistula plug has been reported to provide success rates as high as 80%. The purpose of this study was to evaluate our results with this new method....
We are grateful for the possibility to reply the comments by Dr de la Portilla. We are conscious that 5 months, or 12 as affirmed by Dr de la Portilla, is sufficient to assess healing of an anal fistu...
