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NCT00658385 · ClinicalTrials.gov registry record · NA
Assess the Feasibility and Safety of Granulocyte Colony Stimulating Factor (GCSF) Mobilization of CD34+ Hematopoietic Progenitor Cells in Patients With Betathalassemia Major
A NA study, sponsored by Memorial Sloan Kettering Cancer Center.
- Completed
- Registry status
- NA
- Development phase
- 5
- Enrollment target
NCT00658385: Completed NA study, sponsored by Memorial Sloan Kettering Cancer Center.
NCT00658385 is a NA study that has completed, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 5 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT00658385, a NA study, has completed, sponsored by Memorial Sloan Kettering Cancer Center.
- COMPLETED
- Registry status
- NA
- Development phase
- 5 participants
- Enrollment target
Study Summary
Betathalassemia major is a disease of the blood and bone marrow. You were born with it and it has made you unable to make normal hemoglobin and red cells. You have been receiving red blood cell transfusions all your life. These transfusions do not cure your disease. The problem with transfusions is that they contain a lot of iron. With time iron builds up in your body and will eventually hurt some of your organs . Because of this buildup of iron , you are taking medicine that helps your body get rid of the extra iron. Today, the only other treatment is bone marrow or stem cell transplant. It can only be done when a matched donor is available. This is most often a brother, sister, or parent. Bone marrow transplant may cure betathalassemia major. If you have a transplant and it is successful, you will no longer have the disease. Without a matched sibling or parent, the standard treatment is to keep having transfusions. In the near future, we will be testing a new treatment for making normal hemoglobin and normal red blood cells. We have recreated the healthy hemoglobin gene in a test tube. We are able to use it and put it back into cells. This is called gene therapy. We have been able to put this gene into the stem cells of mice with thalassemia. These mice were cured. We now plan to take that gene and put it into stem cells from people who have betathalassemia major. We will then inject those stem cells back into that person's blood. In general, we can obtain more stem cells from the blood of a person than from the bone marrow . In order to do so, we must give that person a blood growth factor. The growth factor stimulates the bone marrow to make more stem cells. That growth factor is called granulocyte colony stimulating factor (GCSF), or Filgrastim. The purpose of this trial is to find out if the drug GCSF has any side effects on you, and if you will make more stem cells in response to it. This trial is not a gene therapy trial. This trial will not help your th
Interventions
- GENETIC GCSF, Central venous line placement, Stem cell Collection (leukapheresis)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2008-04 |
| Est. Completion | 2011-02 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00658385
The ClinicalTrials.gov registry entry for NCT00658385 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 5 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Memorial Sloan Kettering Cancer Center, which has 1,884 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which GCSF, Central venous line placement, Stem cell Collection (leukapheresis) is the first listed.
NCT00658385 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00658385 about?
NCT00658385 is a clinical study titled "Assess the Feasibility and Safety of Granulocyte Colony Stimulating Factor (GCSF) Mobilization of CD34+ Hematopoietic Progenitor Cells in Patients With Betathalassemia Major". Betathalassemia major is a disease of the blood and bone marrow. You were born with it and it has made you unable to make normal hemoglobin and red cells. You have been receiving red blood cell transfusions all your life. These transfusions do not cure your disease. The problem with transfusions is ...
What is the current status of trial NCT00658385?
This trial is currently completed. It is a NA study. The enrollment target is 5 participants. The study started on 2008-04. Estimated completion is 2011-02.
What interventions are being tested in trial NCT00658385?
The interventions under investigation include: GCSF, Central venous line placement, Stem cell Collection (leukapheresis) (GENETIC).
Who is sponsoring clinical trial NCT00658385?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
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