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| Name | Class |
|---|---|
| Michigan State University | OTHER |
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Viral infections and reactivation during pediatric allogeneic hematopoietic stem cell transplantation (HSCT) are a common occurrence and significantly contribute to post-transplant morbidity and mortality. The risk is high due to prolonged periods of immune deficiency while awaiting immune reconstitution post-transplant. Current strategies to reduce complications from viral infections include prophylactic treatment, close monitoring for viral infections and prompt treatment at the first sign of symptoms or increasing viral load. However, the most definitive treatment for viral infections remains the host's cellular defenses. Improved understanding of the immune systems response to viral infections may lead to better treatment strategies.
This study is being done to explore the relationships between T-cells and NK cells (infection fighting cells) and viral infections or reactivations in young allogeneic stem cell transplant patients. The investigators will be looking at how these cells react and function in young patients receiving allogeneic stem cell transplantation, as well as in healthy stem cell donors.
PRIMARY OBJECTIVE:
SECONDARY OBJECTIVES:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stem Cell Donors | Allogeneic hematopoietic stem cell transplant (HSCT) donors. Blood samples for phenotypes research will be collected once from donors, prior to apheresis for collection of donor stem cells. | ||
| Stem Cell Recipients | Allogeneic hematopoietic stem cell transplant (HSCT) recipients. Blood samples will be drawn prior to transplantation and every two weeks, up to day 100 post-transplantation. |
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| Measure | Description | Time Frame |
|---|---|---|
| Percentage of KIR+CD45+ T-cells in stem cell recipients and donors | Blood samples will be drawn as follows:
Summary statistics of the two cell populations, such as mean, median, range, and standard error, will be provided. | Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 2 weeks, up to 100 days post-transplantation |
| Number of FcRg-CD56+CD3- NK cells in stem cell recipients and donors | Blood samples will be drawn as follows:
Summary statistics of the two cell populations, such as mean, median, range, and standard error, will be provided. | Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 2 weeks, up to 100 days post-transplantation |
| Measure | Description | Time Frame |
|---|---|---|
| Surface marker expression density of phenotype KIR+CD56+ T-cells and FcRg-CD56+CD3- NK cells in donors and recipients | Blood samples will be drawn as follows:
Surface marker expression density will be calculated and summary statistics will be provided for all calculations. |
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Inclusion Criteria:
Exclusion Criteria:
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The study is planned to enroll 50 pediatric allogeneic hematopoietic stem cell transplant (HSCT) patients and 50 donors. All patients/donors who meet eligibility criteria and sign the consent form will be enrolled on the study.
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| Name | Affiliation | Role |
|---|---|---|
| Aimee Talleur, MD | St. Jude Children's Research Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105 | United States |
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| Label | URL |
|---|---|
| St. Jude Children's Research Hospital | View source |
| Clinical Trials Open at St. Jude | View source |
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| ID | Term |
|---|---|
| D019337 | Hematologic Neoplasms |
| D007239 | Infections |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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| Donors once within 1 week prior to stem cell donation. HSCT recipients: within 1 week prior to stem cell infusion and within 1 week of 100 days post-transplantation |
| Percentage of KIR+CD56+ T-cells that stain for tetramer/pentamer | Blood samples will be drawn as follows:
The specificity of KIR+CD56+T-cells will be evaluated through viral tetramer/pentamer staining. | Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 28 days, up to 100 days post-transplantation |
| Change in numbers and percentages of KIR+CD56+T-cells after exposure to viral antigen in vitro and cytokine expression levels | Blood samples will be drawn as follows:
The functional capacity of KIR+CD56+T-cells will be evaluated through proliferation and cytokine production assays. Summary statistics will be provided. | Donors once within 1 week prior to stem cell donation. HSCT recipients: baseline within 1 week prior to stem cell infusion and every 28 days, up to 100 days post-transplantation |
| Number of FcRg-CD56+CD3- NK cells after exposure to cytomegalovirus | Blood samples will be drawn as follows:
Summary statistics of the functional capacity of FcRg-CD56+CD3- NK against CMV-infected cells will be provided. | Donors once within 1 week prior to stem cell donation. HSCT recipients: within 1 week prior to stem cell infusion and within 1 week of 100 days post-transplantation |