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Intrathecal Enzyme Replacement for Hurler Syndrome | Clinical Trials | Clareo Health

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COMPLETEDPhase 1NCT00638547

Intrathecal Enzyme Replacement for Hurler Syndrome

This protocol will examine whether the enzyme alpha-L-iduronidase (Laronidase), delivered into the spinal fluid of patients with Hurler syndrome at intervals before and after bone marrow transplant, i...

Lead sponsor: Masonic Cancer Center, University of Minnesota•1 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Masonic Cancer Center, University of Minnesota

Subjects will receive an infusion of Laronidase into his/her spinal fluid approximately 12 weeks before, 2 weeks before, 100 days after and 6 months after transplant. This procedure is done by lumbar puncture (also called a "spinal tap").

Age

0 - 3 years

Sex

ALL

Healthy Volunteers

No

Inclusion Criteria

•Patients with a diagnosis of MPS IH (Hurler syndrome) are candidates for this protocol if they are being considered for hematopoietic stem cell transplantation according the University of Minnesota guidelines.

Exclusion Criteria

•Patients are less than 6 months old, or older than 3 years of age.
•There is a history of clinically-severe hypersensitivity to Laronidase.
•There is a contraindication for repeated lumbar puncture.
•The family is not willing to undergo the necessary procedures and evaluations inherent in the study.
•Consent has not been signed for participation in the 2004-09 study of intravenous Laronidase administration.

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: December 3, 2018Terms

Trial snapshot

StatusCOMPLETED

PhasePHASE1

Enrollment26

Start dateJan 2008

Last updatedDec 3, 2018

Condition

Hurler Syndrome

Locations shown

University of Minnesota, Fairview

Minneapolis, Minnesota

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 3, 2018Data synced to Clareo: May 10, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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