ClinicalTrials.gg
Status unknownNCT00005900Updated Jun 24, 2005

Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation

An observational study in I Cell Disease, Fucosidosis and Globoid Cell Leukodystrophy, sponsored by Fairview University Medical Center. Status unknown at 1 site in United States. Open to participants aged 0 Years and older. Per ClinicalTrials.gov, last updated 2005-06-24.

Sponsored by Fairview University Medical Center · Observational

The sponsor has not verified this record recently (last verified Oct 2003), so the status shown — last known as Active, not recruiting — may be out of date.
Study type
Observational
Enrollment
10
Ages
0 Years and older
Sex
All
01

Study summary

OBJECTIVES: I. Evaluate bronchoalveolar lavage fluid and serum obtained from pediatric patients with storage disorders prior to allogeneic hematopoietic stem cell transplantation (HSCT) for the presence of proinflammatory cytokines and for the production of nitric oxide by alveolar macrophages to identify possible risk factors for pulmonary complications.

II. Investigate the underlying mechanism for the development of significant pulmonary complications in these patients during HSCT.

III. Evaluate bronchoalveolar lavage fluid and serum obtained from these same patients at the time a pulmonary complication develops post-HSCT, or at 60 days post-HSCT if there has been no pulmonary complications.

Read the detailed description

PROTOCOL OUTLINE:

Patients undergo bronchoscopy with bronchoalveolar lavage (BAL) prior to allogeneic hematopoietic stem cell transplantation (HSCT). ELISA assays for cytokines are performed. Patients are followed post-HSCT for the development of transplant related pulmonary complications. A repeat bronchoscopy with BAL is performed at the time pulmonary complications develop or at day 60 post-HSCT if no complications develop. Cytokine assays are repeated.

02

Conditions studied

  • I Cell Disease
  • Fucosidosis
  • Globoid Cell Leukodystrophy
  • Adrenoleukodystrophy
  • Mannosidosis
  • Niemann-Pick Disease
  • Pulmonary Complications
  • Mucopolysaccharidosis I
  • Mucopolysaccharidosis VI
  • Metachromatic Leukodystrophy
  • Gaucher's Disease
  • Wolman Disease

Keywords

  • Gaucher's disease
  • I cell disease
  • Niemann-Pick disease
  • Wolman disease
  • adrenoleukodystrophy
  • disease-related problem/condition
  • fucosidosis
  • genetic diseases and dysmorphic syndromes
  • globoid cell leukodystrophy
  • inborn errors of metabolism
  • mannosidosis
  • metachromatic leukodystrophy
  • mucopolysaccharidosis
  • mucopolysaccharidosis I
  • mucopolysaccharidosis VI
  • oncologic disorders
  • pulmonary complications
  • rare disease
  • sphingolipidoses
03

In context

Leukodystrophy, Globoid Cell

31 studies on the registry are indexed under Leukodystrophy, Globoid Cell; 8 are open to participants now.

This study's enrollment of 10 is below the median of 55 across 14 observational studies indexed under Leukodystrophy, Globoid Cell.

Browse Leukodystrophy, Globoid Cell studies →

Lead sponsor

Fairview University Medical Center is the lead sponsor of 7 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
0 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

  • Diagnosis of an inborn error of metabolism eligible for hematopoietic stem cell transplantation on protocol UMN-MT-1995-01
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Allogeneic and autologous transplant

Stem cell (bone marrow) transplants. Allogeneic uses cells from a donor; autologous uses your own cells, collected earlier and given back.

05

Study design

Enrollment
10 participants
06

Study locations

1 site
  • Fairview University Medical Center
    Minneapolis, Minnesota 55455, United States
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2005, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00005900
Lead sponsor
Fairview University Medical Center
First posted
Jun 5, 2000
Start date
Aug 1999
Last update
Jun 24, 2005

Study contacts

K. Scott Baker
study chair · Fairview University Medical Center
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2003. You cannot join it, but the record below documents what was studied.

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