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Stem Cell Transplant for Bone Marrow Failure Syndromes

NCT00176878 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2017-12-28

Study results available
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Summary

The researchers hypothesize that it will be possible to perform unrelated bone marrow or cord blood transplants in a safer manner by using less intensive therapy yet still achieve an acceptable level of donor cell engraftment for non-malignant congenital bone marrow failure disorders.

Conditions

Interventions

PROCEDURE

Stem cell transplant

Stem cell transplant on Day 0 - healthy marrow from an unrelated individual. A minimum of 1.0 x 10\^9/kg nucleated cells/kg ideal body weight will be collected with a goal of 2.0 x 10\^9/kg.

DRUG

Fludarabine monophosphate

fludarabine 175 mg/m\^2 (total) on Days -6 through -3.

PROCEDURE

Total lymphoid irradiation

Dose 500 cGy radiation therapy to specific areas of the body

DRUG

Busulfan

Busulfan 8 mg/kg (total) on Days - 8 and -7 (orally or through the catheter),

BIOLOGICAL

anti-thymocyte globulin

anti-thymocyte globulin (ATG) 15 mg/kg on days -2 and -1 via catheter

Sponsors & Collaborators

  • Masonic Cancer Center, University of Minnesota

    lead OTHER

Principal Investigators

  • Paul Orchard, MD · University of Minnesota Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-06-30
Primary Completion
2009-03-31
Completion
2009-03-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT00176878 on ClinicalTrials.gov