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Fetal Umbilical Cord Blood (UCB) Transplant for Lysosomal Storage Diseases

NCT01003912 · Status: WITHDRAWN · Phase: PHASE1 · Type: INTERVENTIONAL

Last updated 2017-06-29

No results posted yet for this study

Summary

The purpose of this study is to determine if it is safe to administer unrelated umbilical cord blood to pregnant women in their first trimester of pregnancy with a fetus that has a known diagnosis of certain lysosomal storage diseases. These diseases are known to cause severe and irreversible neurological disability in early infancy and which are lethal in childhood.

Conditions

  • Lysosomal Storage Diseases
  • Inborn Errors of Metabolism

Interventions

BIOLOGICAL

ALD-601

ALD-601 is manufactured by Aldagen from the 20% compartment of the selected umbilical cord blood unit within 24 hrs of planned injection. A dose of ALD-601 that delivers 1 x 105 - 2 x 106 cells/kg of estimated fetal weight at day - 1 is suspended in 300 microliters of dialysis media.

Sponsors & Collaborators

  • Aldagen

    collaborator INDUSTRY

  • Joanne Kurtzberg, MD

    lead OTHER

Principal Investigators

  • Joanne Kurtzberg, MD · Duke University

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-10-31
Primary Completion
2017-03-31
Completion
2017-03-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01003912 on ClinicalTrials.gov