Vesicoureteral Reflux Clinical Trial
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.
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.
;
Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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