Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux
|ClinicalTrials.gov Identifier: NCT00004487|
Recruitment Status : Unknown
Verified April 2001 by FDA Office of Orphan Products Development.
Recruitment status was: Active, not recruiting
First Posted : October 19, 1999
Last Update Posted : March 25, 2015
OBJECTIVES: I. Determine the safety and efficacy of chondrocyte alginate gel suspension in pediatric patients with vesicoureteral reflux.
II. Determine the long term efficacy of this treatment regimen in this patient population.
III. Evaluate the short and long term avoidance of surgery or antibiotic therapy after this treatment regimen in this patient population.
IV. Estimate the risk:benefit ratio of this treatment regimen in these patients.
|Condition or disease||Intervention/treatment||Phase|
|Vesicoureteral Reflux||Drug: chondrocyte-alginate gel suspension||Phase 3|
PROTOCOL OUTLINE: This is a multicenter study. Patients undergo biopsy of the auricular cartilage for chondrocytes during cystoscopic evaluation on day 1. Chondrocyte alginate gel suspension is injected into the submucosa of the bladder at the vesicoureteral junction between days 40-50. Patients found to have post treatment reflux may be retreated once.
Patients are followed at 1, 3, and 12 months.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||60 participants|
|Study Start Date :||May 1999|
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004487
|Study Chair:||Frank T. Gentile||Curis, Inc.|