Status:
COMPLETED
Safety Study of ADV-specific T-cells in Paediatric Patients Post Allo-HSCT
Lead Sponsor:
Cell Medica Ltd
Collaborating Sponsors:
Technology Strategy Board, United Kingdom
Conditions:
ADV Infection Post Allo-HSCT
Eligibility:
All Genders
Up to 16 years
Phase:
PHASE1
PHASE2
Brief Summary
Human Adenovirus-specific T-cells can persist and augment impaired adenovirus immune response post allogeneic haematopoietic stem cell transplant, and reduce the requirement for antiviral therapy with...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2016
Estimated Enrollment :
8 Patients enrolled
Trial Details
Trial ID
NCT01822093
Start Date
December 1 2012
End Date
December 31 2016
Last Update
January 25 2018
Active Locations (3)
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1
Great Ormond Street Hospital
London, United Kingdom
2
Royal Manchester Children's Hospital
Manchester, United Kingdom
3
Royal Victoria Infirmary
Newcastle, United Kingdom