Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
Summary
Up to date, a sure cure for Crohn's fistula does not known and the fistula recurrence rate is high. On 15 October 2008, orphan designation was granted by Korea FDA for human adipose-derived stem cell (ADIPOPLUS) for the treatment of Crohn's fistula. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to evaluate the safety and efficacy.
Study Design
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Conditions
Crohn's Fistula
Intervention
ADIPOPLUS
Location
Asan medical center
Seoul
Korea, Republic of
138-736
Status
Recruiting
Source
Anterogen Co., Ltd.
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01011244
- 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).
Crohn Disease
A chronic transmural inflammation that may involve any part of the DIGESTIVE TRACT from MOUTH to ANUS, mostly found in the ILEUM, the CECUM, and the COLON. In Crohn disease, the inflammation, extending through the intestinal wall from the MUCOSA to the serosa, is characteristically asymmetric and segmental. Epithelioid GRANULOMAS may be seen in some patients.
Granulomatosis, Orofacial
A condition characterized by persistent or recurrent labial enlargement, ORAL ULCER, and other orofacial manifestations in the absence of identifiable CROHN DISEASE; or SARCOIDOSIS. There is no consensus on whether orofacial granulomatosis is a distinct clinical disorder or an initial presentation of Crohn disease.
Oroantral Fistula
A fistula between the maxillary sinus and the oral cavity.
Clinical Trials
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.
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...
The purpose of this study is to evaluate the safety of adalimumab for treatment of patients with moderate to severe Crohn's Disease (CD) and to measure the effects of treatment on patient...
The purpose of this study is to determine safety and efficacy of allogenic eASCs (expanded adult stem cells) for the treatment of recto-vaginal fistula in patients with Crohn´s disease.
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...
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...
BACKGROUND: The aim of the study was a cross-sectional investigation into the types of anal fistulae in patients with Crohn's disease using 3-dimensional endoanal ultrasonography. METHODS: The study p...
BACKGROUND: CARD15 mutations alter bowel immunity and increase susceptibility to Crohn's disease (CD). However, the relation between these mutations and Crohn's perianal fistulas has not been fully cl...
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....
The patient was a 40-year-old man who had suffered from Crohn's disease (CD) for 19 years and developed an intractable perianal fistula and two strictures in the small bowel. Dilatation of the two str...
