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Status unknownNCT00004487Updated Mar 25, 2015

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

A Phase 3 interventional study of chondrocyte-alginate gel suspension in Vesicoureteral Reflux, sponsored by FDA Office of Orphan Products Development. Status unknown. Open to participants aged 6 Months to 18 Years. Per ClinicalTrials.gov, last updated 2015-03-25.

Sponsored by FDA Office of Orphan Products Development · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Apr 2001), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
60
Ages
6 Months to 18 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Vesicoureteral Reflux

Keywords

  • rare disease
  • renal and genitourinary disorders
  • vesicoureteral reflux
03

In context

Gastroesophageal Reflux

1,067 studies on the registry are indexed under Gastroesophageal Reflux; 188 are open to participants now.

This study's enrollment of 60 is below the median of 72 across 712 interventional studies indexed under Gastroesophageal Reflux.

Browse Gastroesophageal Reflux studies →

Lead sponsor

FDA Office of Orphan Products Development is the lead sponsor of 31 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Months to 18 Years
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility 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
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Enrollment
60 participants

Interventions

  • Drugchondrocyte-alginate gel suspension
06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 25, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00004487
Lead sponsor
FDA Office of Orphan Products Development
Collaborators
Curis, Inc.
First posted
Oct 19, 1999
Start date
May 1999
Last update
Mar 25, 2015

Study contacts

Frank T. Gentile
study chair · Curis, Inc.
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Apr 2001. You cannot join it, but the record below documents what was studied.

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