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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified April 2001 by FDA Office of Orphan Products Development.
Recruitment status was:  Active, not recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00004487
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Curis, Inc.
Information provided by:
FDA Office of Orphan Products Development
  Purpose

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
Vesicoureteral Reflux Drug: chondrocyte-alginate gel suspension Phase 3

Study Type: Interventional
Study Design: Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by FDA Office of Orphan Products Development:

Estimated Enrollment: 60
Study Start Date: May 1999
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.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Months to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00004487


Sponsors and Collaborators
FDA Office of Orphan Products Development
Curis, Inc.
Investigators
Study Chair: Frank T. Gentile Curis, Inc.
  More Information

ClinicalTrials.gov Identifier: NCT00004487     History of Changes
Other Study ID Numbers: 199/14267
REPRO-FDR001514
REPRO-99-07
First Submitted: October 18, 1999
First Posted: October 19, 1999
Last Update Posted: March 25, 2015
Last Verified: April 2001

Keywords provided by FDA Office of Orphan Products Development:
rare disease
renal and genitourinary disorders
vesicoureteral reflux

Additional relevant MeSH terms:
Gastroesophageal Reflux
Vesico-Ureteral Reflux
Esophageal Motility Disorders
Deglutition Disorders
Esophageal Diseases
Gastrointestinal Diseases
Digestive System Diseases
Urinary Bladder Diseases
Urologic Diseases
Alginic acid
Hemostatics
Coagulants
Radiation-Protective Agents
Protective Agents
Physiological Effects of Drugs