Gene Therapy for Chronic Granulomatous Disease

NCT00564759 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 2

Last updated 2007-11-28

No results posted yet for this study

Summary

The aim of the study is to evaluate the side effects and risks after infusion of retroviral gene corrected autologous CD34+ cells of the peripheral blood of chemotherapy conditioned (busulphan)patients with chronic granulomatous disease (CGD). Also gene corrected and functional active granulocytes in the peripheral blood and the engraftment in the bone marrow of the patients will be monitored an documented.

Conditions

  • Granulomatous Disease, Chronic

Interventions

DRUG

retroviral SF71-gp91phox transduced CD34+ cells

autologous ex-vivo retroviral transduced (SF71-gp91phox) CD34+ cells

Sponsors & Collaborators

  • German Federal Ministry of Education and Research

    collaborator OTHER_GOV
  • Johann Wolfgang Goethe University Hospital

    lead OTHER

Principal Investigators

  • Dieter Hoelzer, MD, PhD · Goethe University

Study Design

Allocation
NON_RANDOMIZED
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2004-01-31
Completion
2008-12-31

Countries

  • Germany

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 NCT00564759 on ClinicalTrials.gov