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Sponsors and Collaborators: |
FDA Office of Orphan Products Development Curis, Inc. |
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Information provided by: | FDA Office of Orphan Products Development |
ClinicalTrials.gov Identifier: | NCT00004487 |
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 | Intervention | Phase |
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Vesicoureteral Reflux |
Drug: chondrocyte-alginate gel suspension |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Safety/Efficacy Study |
Estimated Enrollment: | 60 |
Study Start Date: | May 1999 |
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 to 18 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
--Prior/Concurrent Therapy--
--Patient Characteristics--
Study ID Numbers: | 199/14267, REPRO-FDR001514, REPRO-99-07 |
Study First Received: | October 18, 1999 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00004487 |
Health Authority: | United States: Federal Government |
rare disease renal and genitourinary disorders vesicoureteral reflux |
Vesico-Ureteral Reflux Cystocele Alginic acid |
Urologic Diseases Urinary Bladder Diseases Rare Diseases |
Radiation-Protective Agents Coagulants Therapeutic Uses Physiological Effects of Drugs |
Hematologic Agents Protective Agents Pharmacologic Actions Hemostatics |