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Allogeneic Hematopoietic Stem Cell Transplant For Epidermolysis Bullosa

NCT00478244 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2017-12-28

Study results available
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Summary

RATIONALE: In animal models, stem cells have been shown to home to the skin and repair the biochemical and structural abnormalities associated with recessive dystrophic epidermolysis bullosa (RDEB) (collagen 7 deficiency).

PURPOSE: To determine the safety and effectiveness of stem cell infusion in the treatment of RDEB.

Conditions

  • Epidermolysis Bullosa

Interventions

DRUG

busulfan

Day -9 through Day -6: 1.1 mg/kg if \< 12 kg IV every 6 hours; 0.8 mg/kg if \> 12 kg.

DRUG

cyclophosphamide

Day -5 through Day -2: 50 mg/kg IV over 120 min.

DRUG

fludarabine phosphate

Day -5 through Day -3: 25 mg/m2 IV over 60 min.

PROCEDURE

hematopoietic bone marrow transplantation

allogeneic bone marrow, peripheral stem cell or umbilical cord blood transplantation

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • John E. Wagner, MD · Masonic Cancer Center, University of Minnesota

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
25 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2007-04-30
Primary Completion
2011-08-31
Completion
2011-08-31

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT00478244 on ClinicalTrials.gov