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| Name | Class |
|---|---|
| Hoxworth Blood Center | OTHER |
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The purpose of this research study is to learn more about the use of viral specific T-lymphocytes (VSTs) to prevent or treat viral infections that may happen after allogeneic stem cell transplant. Allogeneic means the stem cells come from another person. VSTs are cells specially designed to fight viral infections that may happen after a stem cell transplant (SCT).
Stem cell transplant reduces the body's ability to fight infections. Viral infections are a common problem after transplant and can cause significant complications. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find a better way to treat these infections.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| VSTs to Prevent | Experimental | VSTs are given through an IV infusion 21-30 days after transplant to see if the VSTs will help prevent a viral infection. |
|
| VSTs to Treat | Experimental | VSTs will be given only if a viral infection develops. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Viral Specific T-cells (VSTs) Scheduled | Biological | VSTs will be infused into stem cell transplant recipients on schedule. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Treatment Failures | Treatment failure is defined as EBV>100,000, BKV >100,000, CMV >5,000 or Adv >50,000 at any time post randomization. | 21 - 100 days after transplant |
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SCHEDULED ARM:
Inclusion Criteria:
Exclusion Criteria:
TREATMENT ARM
Inclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Celeste Dourson, MS | Contact | 513-636-7679 | Celeste.Dourson@cchmc.org | |
| Jamie Wilhelm, BS | Contact | 513-803-1102 | Jamie.Wilhelm@cchmc.org |
| Name | Affiliation | Role |
|---|---|---|
| Stella Davies, MBBS, PhD | Children's Hospital Medical Center, Cincinnati | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cincinnati Children's Hospital Medical Center | Recruiting | Cincinnati | Ohio | 45229 | United States |
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| Viral Specific T-cells (VSTs) Treatment | Biological | VSTs will be infused into stem cell transplant recipients only if viremia is detected. |
|
| ID | Term |
|---|---|
| D014777 | Virus Diseases |
| ID | Term |
|---|---|
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001071 | Appointments and Schedules |
| D013812 | Therapeutics |
| ID | Term |
|---|---|
| D009934 | Organization and Administration |
| D006298 | Health Services Administration |
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