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	Treatment or Intervention	Phase
Vesicoureteral Reflux	Drug: chondrocyte-alginate gel suspension	Phase III

Further Study Details: 

Expected Total Enrollment:  60

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.

Ages Eligible for Study:  6 Months   -   18 Years,  Genders Eligible for Study:  Both

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

• Confirmed grade 3 or 4 reflux in at least one ureter by voiding cystourethrogram Breakthrough urinary tract infection despite standard antibiotic therapy OR Persistent reflux unlikely to resolve spontaneously
• Grade 3: 2 year reflux duration OR 1 breakthrough infection Grade 4: 1 year reflux duration OR 1 breakthrough infection
• Coexisting grade 1 or 2 reflux OR Resolved reflux (i.e., contralateral to the existing grade 3 or 4 refluxing ureter) allowed
• No reflux secondary to obstruction or neuropathic disease
• No gross urological abnormalities (e.g., megaureter requiring ureteral tapering or duplicity of ureters)

--Prior/Concurrent Therapy--

• Surgery: No prior surgery for correction of reflux No recent prior urological device implantation

--Patient Characteristics--

• Hematopoietic: No history of bleeding disorders
• Cardiovascular: No history of hypertension or cardiac disease
• Pulmonary: No history of pulmonary disease
• Other: No known allergies to contrast dyes, iodine, or shellfish No contraindications to general anesthesia No prior infections (other than UTIs) No immunodeficiencies No metabolic disease No social situation that would interfere with follow up Not pregnant Negative pregnancy test

Study chairs or principal investigators

Frank T. Gentile,  Study Chair,  Curis   

Study ID Numbers:  199/14267; REPRO-FDR001514; REPRO-99-07
Record last reviewed:  April 2001
Last Updated:  October 13, 2004
Record first received:  October 18, 1999
ClinicalTrials.gov Identifier:  NCT00004487
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08