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NCT00004294 · ClinicalTrials.gov registry record · Phase 1

Phase I Study of Retrovirally Mediated Transfer of the Human Glucocerebrosidase Gene Into Peripheral Blood Stem Cells for Autologous Transplantation in Patients With Type I Gaucher Disease

A Phase 1 study, sponsored by National Center for Research Resources (NCRR).

Completed
Registry status
Phase 1
Development phase
15
Enrollment target

NCT00004294 is a Phase 1 study that has completed, run by National Center for Research Resources (NCRR). The registered enrollment target is 15 participants.

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The verdict

NCT00004294, a Phase 1 study, has completed, sponsored by National Center for Research Resources (NCRR).

COMPLETED
Registry status
Phase 1
Development phase
15 participants
Enrollment target

Study Summary

OBJECTIVES: I. Transfer the human glucocerebrosidase (GC) gene into peripheral blood stem cells (PBSC) obtained from patients with type I Gaucher disease using a retroviral vector. II. Transplant the autologous transduced PBSC in these patients. III. Measure the carriage and expression of the transferred gene and its duration in peripheral blood leukocytes. IV. Assess the clinical effects of transplanting genetically corrected PBSC.

Interventions

  • GENETIC human glucocerebrosidase gene into autologous peripheral blood stem cells

Trial Details

FieldValue
Enrollment Target 15 participants
Start Date 1999-11
Phase Phase 1

What the Registry Record Tells You About NCT00004294

The ClinicalTrials.gov registry entry for NCT00004294 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 15 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 1 intervention - of which human glucocerebrosidase gene into autologous peripheral blood stem cells is the first listed.

NCT00004294 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00004294 about?

NCT00004294 is a clinical study titled "Phase I Study of Retrovirally Mediated Transfer of the Human Glucocerebrosidase Gene Into Peripheral Blood Stem Cells for Autologous Transplantation in Patients With Type I Gaucher Disease". OBJECTIVES: I. Transfer the human glucocerebrosidase (GC) gene into peripheral blood stem cells (PBSC) obtained from patients with type I Gaucher disease using a retroviral vector. II. Transplant the autologous transduced PBSC in these patients. III. Measure the carriage and expression of the trans...

What is the current status of trial NCT00004294?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 15 participants. The study started on 1999-11.

What interventions are being tested in trial NCT00004294?

The interventions under investigation include: human glucocerebrosidase gene into autologous peripheral blood stem cells (GENETIC).

Who is sponsoring clinical trial NCT00004294?

This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.