Improved Methods of Cell Selection for Bone Marrow Transplant Alternatives
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00001529|
Recruitment Status : Recruiting
First Posted : November 4, 1999
Last Update Posted : April 25, 2018
Bone marrow transplants (BMT) are one form of treatment for disorders of the blood, including leukemia. However, because the procedure is often associated with potentially life-threatening reactions, it is usually reserved for patients with serious illnesses under the age of 60 years old.
One serious reaction complicating bone marrow transplants is referred to as graft-versus-host disease (GVHD). GVHD is a potentially fatal incompatibility reaction. The reaction is caused by antigens found on the cells of the patient that are not present on the cells of the donor. The antigens are recognized by transplanted white blood cells (lymphocytes). These lymphocytes begin attacking the recipient s cells and tissues and may lead to death.
In order to avoid GVHD, researchers have developed a technique using peripheral blood instead of bone marrow that allows transplantation of stem cells and removal of lymphocytes. Stem cells are the cells responsible for returning blood cell production to normal. Lymphocytes are the white blood cells that can cause GVHD.
The technique requires two steps. In the first step blood cells are collected from donors who have received doses of a growth factor. The growth factor (granulocyte colony stimulating factor) is designed to increase the production of donor stem cells.
In the second step white blood cell lymphocytes are removed from the collected blood, leaving only the stem cells.
The main goal of this study is to develop and improve the method of processing cells that are collected after stimulation with growth factor (G-CSF), by removing the white blood cell lymphocytes which can cause graft-versus-host disease (GVHD) while keeping the stem cells necessary for healthy blood cell building. In addition, researchers are interested in studying whether giving G-CSF has an effect on lymphocyte function, which may influence the immune reactions occurring in bone marrow transplantation.
|Condition or disease||Intervention/treatment||Phase|
|Graft vs Host Disease Healthy Lymphopenia||Drug: G-CSF||Phase 1|
The NHLBI Hematology Branch Stem Cell Transplantation program is exploring ways to make allogeneic transplantation safer and more widely applicable. Prior Hematology Branch transplant protocols have evaluated the strategy of using T cell depleted marrow transplants followed by delayed lymphocyte add-back to control or prevent GVHD while conserving useful donor immune function against residual leukemia and infectious agents. Over the past ten years, a number of increasingly efficient methods have been used to deplete T cells but retain stem cells, and we have shown the safety and utility of the delayed T cell add-back approach. We have also found a positive relationship between administration of higher CD34+ cell doses and outcome. Investigation of highly purified grafts with add-back of specific T cell populations is ongoing, and the ability to test new purification approaches and devices on clinical-scale PBSC products is critical to the continued development of new transplantation approaches in our program. This requires testing the approaches on G-CSF mobilized PBSCs collected by apheresis from healthy donors, since this is the cell source that will be used in all clinical allogeneic transplantation protocols in our program.
Therefore, the primary intent of this protocol is to provide a mechanism for mobilizing, collecting, storing, and analyzing G-CSF mobilized apheresis samples from healthy volunteers. Cells will be used to develop a method of processing the cells that are collected after stimulation with G-CSF, by removing the lymphocytes, which can mediate GVHD while retaining the stem cells which are necessary for hematopoietic reconstitution. At the same time we will study whether G-CSF administration has an effect on the lymphocyte, function which may influence the immune reactions occurring in allogeneic bone marrow transplantation. Furthermore the CD34+ cells collected will be a valuable resource for experimental studies of lymphocyte-stem cell interactions in our laboratory.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||99999999 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Granulocyte Colony Stimulating Factor (G-CSF) Mobilized Leukapheresis Collections From Healthy Volunteers to Develop Improved Methods of Stem Cell and Lymphocyte Selection for Allogeneic Transplantation|
|Study Start Date :||March 14, 1996|
|Estimated Primary Completion Date :||May 1, 2030|
|Estimated Study Completion Date :||May 1, 2030|
- Enumeration of laboratory studies using collected primitive hematopoietic cells and immune effector cells.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00001529
|Contact: Tatyana Worthy, R.N.||(301) firstname.lastname@example.org|
|Contact: Andre Larochelle, M.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Andre Larochelle, M.D.||National Heart, Lung, and Blood Institute (NHLBI)|