ASPIREPhase I/II Study Investigating the Safety of ADV Specific T Cells in High-risk Paediatric Patients Post Allo-HSCT to Treat ADV Reactivation

Fecha de inicio: 1 de diciembre de 2012

Inclusion Criteria: Patients: Age 16 years or younger Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor The subject (or legally acceptable representative) must give informed consent (and assent for subjects ≥ 12 years). All subjects will have a parent or guardian provide informed consent and the subject will provide witnessed verbal assent Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG. Donors Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG Passed medical assessment for stem cell donation HdADV seropositive Signed informed consent Age 16 years or older Exclusion Criteria: Patients Pregnant or lactating females Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae Human Immunodeficiency Virus (HIV) infection Donors Pregnant or lactating females (assessed prior to apheresis) Platelets < 50x109/L