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Home > "S" Clinical Trials Conditions > Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation  Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
For Condition: Pulmonary Complications,Mucopolysaccharidosis I,Mucopolysaccharidosis VI,I Cell Disease,Adrenoleukodystrophy,Wolman Disease,Metachromatic Leukodystrophy,Gaucher's Disease,Mannosidosis,Niemann-Pick Disease,Fucosidosis,Globoid Cell Leukodystrophy
Status: No longer recruiting
Sponsor(s): Fairview University Medical Center ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Observational, Screening
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: - Diagnosis of an inborn error of metabolism eligible for allogeneic hematopoietic stem cell transplantation on protocol UMN-MT-1995-01
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
K.Baker, Study Chair, Fairview University Medical Center
Fairview University Medical Center
Minneapolis, Minnesota, 55455
United States
Additional Information:
Study ID Numbers: 199/15111; UMN-MT-1999-18,UMN-MT-9818
Study Start Date: August 1999
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00005900
Other Mucopolysaccharidosis Vi Studies:
1. Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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Other Mucopolysaccharidosis VI Clinical Trials
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Study of Pulmonary Complications in Pediatric Patients With Storage Disorders Undergoing Allogeneic Hematopoietic Stem Cell Transplantation
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