NCT00004487

Phase III Study of Chondrocyte Alginate Gel Suspension in Pediatric Patients With Vesicoureteral Reflux

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 60 (planned)
• Sponsor: FDA Office of Orphan Products Development · Federal
• Sex: All
• Age: 6 Months – 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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.

Conditions

• Vesicoureteral Reflux

Interventions

Type	Name	Description
DRUG	chondrocyte-alginate gel suspension

Timeline

• Start date: 1999-05-01
• First posted: 1999-10-19
• Last updated: 2015-03-25