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Treatment of Severe Osteogenesis Imperfecta by Allogeneic Bone Marrow Transplantation

NCT00705120 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2008-06-25

No results posted yet for this study

Summary

This protocol was a prospective, Phase I study of allogeneic bone marrow transplantation (BMT) as the primary therapy for Osteogenesis Imperfecta Types II and III. Compatible sibling donors and unrelated donors were stratified and analyzed according to the type of donor. All patients with a sibling donor will received a chemotherapy conditioning regimen; a non-T cell depleted allogeneic marrow, and GVHD prophylaxis. All patients with an unrelated donor will receive a chemoradiotherapy conditioning regimen, a T-cell depleted allogeneic marrow, and GVHD prophylaxis. The primary objective of this study was to investigate the safety and toxicity of these BMT procedures in this particular population.

Conditions

Interventions

OTHER

Bone Marrow Cell Transplantation

RADIATION

Irradiation, Total Body

DRUG

Cyclophosphamide

DRUG

Cyclosporin

PROCEDURE

Mesenchymal Stem Cell Transplantation

DRUG

Busulfan

Sponsors & Collaborators

Principal Investigators

  • Kimberly Kasow, DO · St. Jude Children's Research Hospital

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1995-11-30
Primary Completion
2000-07-31
Completion
2007-10-31

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases
Companies

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 NCT00705120 on ClinicalTrials.gov