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Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait

Primary Purpose

Sickle Cell Trait

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Granulocyte colony-stimulating factor
Leukapheresis
Sponsored by
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sickle Cell Trait focused on measuring Donor Apheresis, Sickle Cell Trait, Red Cell Alloimmunization

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Confirmed diagnosis of sickle cell trait. Greater than age 17. No active systemic infection or history of recurrent infections requiring intravenous antibiotic treatment . Normal renal function: creatinine less than 2X normal, or proteinuria less than 1+. Normal liver function: bilirubin less than 2X normal, transaminases within normal limits. Normal blood count: WBC 3,000-10,000/mm3, granulocytes greater than 1,500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dL, MCV and MCHC within normal limits. Female volunteers of childbearing age should have a negative serum pregnancy test within one week of beginning G-CSF administration. Eligible for normal blood donation (i.e. tested negative for syphilis (RPR), hepatitis B and C (Hasbro, Anti-Hubcap, Anti-HCV), HIV, and HTLV-1. Subject must give informed consent to participate in the protocol. No history of sickle cell crises. Children less than 18 years of age are excluded as is per routine for normal volunteer protocols. No active systemic viral, bacterial, fungal, or parasitic infection. No female volunteers with positive pregnancy test or who are lactating. No history of autoimmune disease, such as rheumatoid arthritis and systemic lupus erythematosus. No history of cancer excluding squamous or basal cell carcinoma of the skin. No history of any malignant hematologic disorders. No history of cardiovascular disease or related symptoms such as chest pain and shortness of breath.. No allergy to G-CSF or bacterial E. coli products. No history of G-CSF administration or leukapheresis.

Sites / Locations

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 3, 2000
Last Updated
March 3, 2008
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00005782
Brief Title
Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait
Official Title
Leukapheresis of Volunteers With Sickle Cell Trait to Evaluate Mobilization of Stem Cells With Granulocyte Colony-Stimulating Factor and Stem Cell Collection and Storage for Allogeneic Transplantation
Study Type
Interventional

2. Study Status

Record Verification Date
July 2002
Overall Recruitment Status
Completed
Study Start Date
January 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2002 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

5. Study Description

Brief Summary
This study will examine the effects of granulocyte colony-stimulating factor (G-CSF) on bone marrow stem cells in healthy volunteers with sickle cell trait and determine if cells collected for transplantation from donors with sickle cell trait require special handling. Stem cells, which the bone marrow produces, are responsible for making all the different kinds of blood cells. They are the cells used in bone marrow, or stem cell, transplantation. The drug G-CSF, which is a naturally occurring hormone, causes stem cells to mobilize-that is, to be released from the bone marrow and enter the blood stream. This drug is given to stem cell donors to increase the amount of cells that can be collected. Stem cell donors for patients with sickle cell disease are often healthy siblings of the patient who have a matching bone marrow type. Some siblings carry the sickle cell trait, however, and, even though they do not have sickle cell disease and their blood and bone marrow are normal, it is not known how their cells will react to G-CSF stimulation. Nor is it known if their stem cells require special methods of removal, processing or storing. Healthy volunteers 18 years or older with sickle cell trait who have no history of sickle cell disease and no known medical problems may be eligible for this study. Participants will have a medical history and physical examination, including blood tests and urinalysis. They will receive injections of G-CSF under the skin once a day for 5 days. On the fifth day, stem cells will be collected through leukapheresis. In this procedure, whole blood is drawn from an arm vein, similar to donating whole blood. The blood then circulates through a cell separator machine, the stem cells are removed, and the rest of the blood is transfused back to the donor through a vein in the other arm. The information gained from this study will be used to ensure the safety of stem cell donors with sickle cell trait and to better prepare stem cells for transplantation in sickle cell patients.
Detailed Description
Patients with sickle cell disease are increasingly becoming eligible for transplantation as the techniques of stem cell transplantation continue to improve, leading to less morbidity and mortality. However, the availability of a matched donor still remains one of the main obstacles. Given the inherited nature of this disease, many HLA-matched siblings of patients with sickle cell disease have sickle cell trait. Therefore, patients with sickle cell trait presumably have been used as donors for patients with sickle cell disease. However, there are no published data on whether special manipulations are required for the maintenance and storage of stem cells collected from patients with sickle cell trait. The effects of granulocyte-colony stimulating factor (G-CSF)-induced stem cell mobilization in these patients are also not known. Also, due to the potential of HbS gellation in red cells, the freezing of stem cells derived from individuals with sickle cell trait may require a more stringent red cell removal than is normally performed. We would like to evaluate these issues using volunteers with sickle cell trait prior to beginning our own transplant protocol for sickle cell disease.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sickle Cell Trait
Keywords
Donor Apheresis, Sickle Cell Trait, Red Cell Alloimmunization

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Enrollment
12 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Granulocyte colony-stimulating factor
Intervention Type
Procedure
Intervention Name(s)
Leukapheresis

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Confirmed diagnosis of sickle cell trait. Greater than age 17. No active systemic infection or history of recurrent infections requiring intravenous antibiotic treatment . Normal renal function: creatinine less than 2X normal, or proteinuria less than 1+. Normal liver function: bilirubin less than 2X normal, transaminases within normal limits. Normal blood count: WBC 3,000-10,000/mm3, granulocytes greater than 1,500/mm3, platelets greater than 150,000/mm3, hemoglobin greater than 12.5g/dL, MCV and MCHC within normal limits. Female volunteers of childbearing age should have a negative serum pregnancy test within one week of beginning G-CSF administration. Eligible for normal blood donation (i.e. tested negative for syphilis (RPR), hepatitis B and C (Hasbro, Anti-Hubcap, Anti-HCV), HIV, and HTLV-1. Subject must give informed consent to participate in the protocol. No history of sickle cell crises. Children less than 18 years of age are excluded as is per routine for normal volunteer protocols. No active systemic viral, bacterial, fungal, or parasitic infection. No female volunteers with positive pregnancy test or who are lactating. No history of autoimmune disease, such as rheumatoid arthritis and systemic lupus erythematosus. No history of cancer excluding squamous or basal cell carcinoma of the skin. No history of any malignant hematologic disorders. No history of cardiovascular disease or related symptoms such as chest pain and shortness of breath.. No allergy to G-CSF or bacterial E. coli products. No history of G-CSF administration or leukapheresis.
Facility Information:
Facility Name
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

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Mobilization and Handling of Stem Cells for Transplant From Healthy Volunteers With Sickle Cell Trait

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