Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Primary Purpose: Treatment
Asan medical center
Korea, Republic of
Anterogen Co., Ltd.
Results (where available)
- Source: http://clinicaltrials.gov/show/NCT01011244
- 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).
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.
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.
A fistula between the maxillary sinus and the oral cavity.
Healing anal fistulas in Crohn's patients with an anal fistula plug.
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To ascertain if a predictor of obstructed labour and obstetric fistula (OF) occurrence could be devised.