Blood Component Transfusion
Conditions
Keywords
Blood Component Transfusion, Leukoreduction, HLA antibody, Immunosuppression
Brief summary
This study is designed to provide information on patients' immune response after exposure to transfused blood. Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of these effects in patients who are not on chemotherapy is unknown. These effects are thought to be due largely to white blood cells present in the transfusion product. Leukofiltration and gamma-irradiation are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. In this study, patients scheduled for cardiac surgery are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response. The levels of sensitization and immunosuppression will be correlated to the transfusion products received.
Detailed description
Blood transfusions may have opposite immune effects on patients. One is sensitization. The other is immunosuppression. The magnitude of this problem in patients who are not on chemotherapy is unknown. Of patients who do receive donor blood, 50-90 percent become sensitized (make antibody) to HLA proteins present on white blood cells in the donor blood. This is an undesired effect in patients who need an organ or stem cell transplant, as it increases the risk of rejection. Another effect of receiving a blood transfusion, immunosuppression, causes a decreased immune response that compromises patients' ability to fight off infection or tumor cells. These effects - sensitization and immunosuppression - are thought to be due largely to white blood cells present in the transfusion product. Doctors order specially pretreated blood transfusions that have been depleted of white blood cells with the aim of minimizing risks in an immunocompromised patient. Leukofiltration and gamma-irradiation are the special treatments that deplete white blood cells. A combination of leukofiltration and gamma-irradiation pretreatment of donor blood is thought to deplete the white blood cells most effectively. Therefore, blood is pretreated both ways before it is given to patients who need a stem cell transplant or others who are immunosuppressed. Sometimes the pretreated leukofiltration and gamma-irradiated blood is used for regular patients who are not immunocompromised so the blood is used before it expires and not wasted. However, doctors do not know for sure whether these expensive pretreatments are really beneficial for regular patients such as those undergoing cardiac surgery and whether they would change the risk of developing sensitization or immunosuppression. In this study, patients are randomly assigned to receive blood products pretreated in one of three ways: untreated, filtered or filtered and irradiated. If their physician orders transfusions, they will receive products assigned to their group. Patients are asked to provide two blood samples during the 4 weeks after surgery. Studies will measure changes in antibody to HLA and in cells that regulate the immune response. It is unknown which treatment (leukofiltration with or without gamma-irradiation compared to no pretreatment) is most beneficial in patients who are not immunosuppressed. This study is designed to provide information on patients' immune response after exposure to transfused blood. This information may be useful to caring for patients in the future who require transfusion for cardiac surgery.
Interventions
BIOLOGICALStandard blood components
Transfusion, if ordered by physician, with unfiltered red blood cells and apheresis platelets
BIOLOGICALLeukoreduced blood components
Transfusion, if ordered by a physician, of leukoreduced red blood cells and apheresis platelets
BIOLOGICALLeukoreduced and irradiated
Transfusion, if ordered by physician, of gamma irradiated leukoreduced red blood cells and gamma irradiated apheresis platelets
Sponsors
National Heart, Lung, and Blood Institute (NHLBI)
Bloodworks
University of Washington
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Investigator, Outcomes Assessor)
Masking description
Clinical teams caring for patients were not masked. Laboratory personnel were masked until all testing completed.
Intervention model description
Individuals who consented for study were scheduled for cardiac surgery. They were randomized to one of three arms to receive blood components prepared by different, but clinically acceptable processes. If they required transfusion from 2 days prior to surgery until 30 days post surgery they received study product. Blood samples were collected prior to surgery and at two points after surgery.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* At least 18 year of age * Scheduled for open heart surgery of cardiopulmonary bypass that involves: CABG, CABG with valve, aneurysm repair * Urgent or elective surgery
Exclusion criteria
* Scheduled for open heart surgery of cardiopulmonary bypass that involves: placement of a ventricular assist device, cardiac transplantation, aortic dissection repair * Emergent surgery * participation in other clinical research studies within 30 days of randomization. * Immunosuppressive treatment. * Refuse blood transfusion * Disease or condition placing subject at undue risk or decision of attending doctor. * Condition requiring high volume transfusion therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in the Production of Antibody to HLA Antigens | 0 to 5 weeks after surgery | Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | 0 to 5 weeks after surgery | Blood samples were collected prior to surgery and at two times after surgery. White blood cells were isolated and frozen. The thawed cells were tested for the numbers and phenotype of regulatory cells and for the production of regulatory cytokines. Results obtained from samples collected after surgery were compared to the results obtained from the sample collected prior to surgery. |
Countries
United States
Participant flow
Recruitment details
Patients scheduled for cardiac surgery at the U. Washington or an affiliated program at Northwest Hospital had the study explained to them by the clinical team including a clinical research coordinator and consent was obtained. Recruitment began in August of 2006 and extended until August of 2010.
Pre-assignment details
There were 7 individuals who consented but were not randomized: late discovery of exclusionary criteria, surgery cancelled, individual withdrew.
Participants by arm
| Arm | Count |
|---|---|
| 4. No Transfusion This arm includes participants from arms 1, 2 and 3 who did not require nor receive transfusions of red blood cells or platelets while they were on study. These participants were moved to this arm after study completion, prior to analysis. | 124 |
| 1. Standard Patients received unfiltered red blood cells and apheresis platelets if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery). | 38 |
| 2. Leukoreduced Patients received filter leukoreduced red blood cells and apheresis platelets collected leukoreduced if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery). | 45 |
| 3. Leukoreduced Gamma Irradiated Patients received filter leukoreduced red blood cells that were gamma irradiated and apheresis platelets collected leukoreduced and gamma irradiated if transfusions were ordered by their providers while on study (2 days prior to surgery to 30 days post surgery). | 38 |
| Total | 245 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Physician Decision | 0 | 3 | 1 | 5 |
| Overall Study | Withdrawal by Subject | 0 | 8 | 10 | 8 |
Baseline characteristics
| Characteristic | 1. Standard | 2. Leukoreduced | 3. Leukoreduced Gamma Irradiated | Total | 4. No Transfusion |
|---|---|---|---|---|---|
| Age, Customized 18 Years and older | 38 Participants | 45 Participants | 38 Participants | 245 Participants | 124 Participants |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 38 participants | 45 participants | 38 participants | 245 participants | 124 participants |
| Sex/Gender, Customized unknown | 38 Participants | 45 Participants | 38 Participants | 245 Participants | 124 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 0 / 124 | 0 / 49 | 0 / 56 | 0 / 51 |
| serious Total, serious adverse events | 0 / 124 | 0 / 49 | 0 / 56 | 0 / 51 |
Outcome results
Primary
Number of Participants With Changes in the Production of Antibody to HLA Antigens
Blood samples were collected prior to surgery and at two times after surgery. Serum was tested for the presence of IgG antibody to HLA. the results of the samples collected after surgery were compared to those in the sample collected prior to surgery.
Time frame: 0 to 5 weeks after surgery
Population: Antibody tests were invalid for some participants in Arm 1. Their sera contained interfering substances.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 4. No Transfusion | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody negative, antibody increased | 2 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody positive, antibody increased | 11 Participants |
| 1. Standard | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody positive, antibody increased | 10 Participants |
| 1. Standard | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody negative, antibody increased | 6 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody negative, antibody increased | 2 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody positive, antibody increased | 10 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody negative, antibody increased | 5 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Production of Antibody to HLA Antigens | Baseline antibody positive, antibody increased | 8 Participants |
Secondary
Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines
Blood samples were collected prior to surgery and at two times after surgery. White blood cells were isolated and frozen. The thawed cells were tested for the numbers and phenotype of regulatory cells and for the production of regulatory cytokines. Results obtained from samples collected after surgery were compared to the results obtained from the sample collected prior to surgery.
Time frame: 0 to 5 weeks after surgery
Population: The study used stringent criteria for acceptance of these cellular assays. Invalid tests were not included in the analysis, therefor the numbers reported in the Outcome Measures table do not add up to the number analyzed for each test.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Not increased | 26 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Not increased | 53 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Increased | 22 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Increased | 45 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Not increased | 57 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Increased | 13 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Not increased | 61 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Not increased | 56 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Increased | 9 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Not increased | 37 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Increased | 8 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Not increased | 59 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Increased | 30 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Increased | 17 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Not increased | 48 Participants |
| 4. No Transfusion | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Increased | 5 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Increased | 10 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Not increased | 9 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Increased | 1 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Not increased | 18 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Increased | 1 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Not increased | 18 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Increased | 1 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Not increased | 18 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Increased | 14 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Not increased | 5 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Increased | 7 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Not increased | 13 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Increased | 9 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Not increased | 11 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Increased | 11 Participants |
| 1. Standard | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Not increased | 7 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Not increased | 7 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Increased | 15 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Not increased | 13 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Not increased | 11 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Not increased | 10 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Not increased | 23 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Not increased | 15 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Increased | 2 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Increased | 2 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Increased | 1 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Not increased | 24 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Increased | 12 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Not increased | 23 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Increased | 11 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Increased | 16 Participants |
| 2. Leukoreduced | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Increased | 9 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Increased | 8 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | IL-10 produced by PBMC | Not increased | 15 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Increased | 4 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Increased | 1 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | CD4+Number of CD25+FoxP3+ T cells | Not increased | 16 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Not increased | 12 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Increased | 3 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Not increased | 19 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IFNg+ iNKT cells | Not increased | 22 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+CD25+CTLA4+ T cells | Not increased | 17 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4+ IL4+ iNKT cells | Increased | 4 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Increased | 2 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Not increased | 22 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- INFg+ iNKT cells | Not increased | 21 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of MNC producing TGFB1 | Increased | 7 Participants |
| 3. Leukoreduced Gamma Irradiated | Number of Participants With Changes in the Number or Cytokine Profile of CD4 T Regulatory Cells or NKT Cells. Number of Participants With Changes in Numbers of Cells Producing TGFB1. Number of Participants With Changes in Secretion of Cytokines | Number of CD4- IL4+ iNKT cells | Increased | 1 Participants |