Adenovirus Specific Paediatric Immune Reconstitutio

Not Applicable

Completed

• Conditions: Allogeneic hematopoietic stem cell transplantation (HSCT) patients considered at high risk of developing adenovirus (ADV) infection; Infections and Infestations; Other transplanted organ and tissue status

• Registration Number: ISRCTN22322271
• Lead Sponsor: Cell Medica Ltd (UK)

Brief Summary

2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29753677 (added 16/04/2019)

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2012-04-12
• Study Completion: 2016-07-31
• Last Update Posted: 15 July 2019

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

Patients:
1. Age 16 years or younger
2. Scheduled to undergo an allogeneic HSCT with an unrelated donor, mismatched unrelated donor, mismatched family donor or haplo identical donor
3. 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
4. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG.

Donors (for manufacturing only):
1. Meets requirements of Directive 2004/23/EC as amended and the UK statutory instruments pursuant therein
2. Negative serology for HIV 1 + 2, HepB, HepC, Syphilis, hCG
3. Passed medical assessment for stem cell donation
4. HdADV seropositive
5. Signed informed consent
6. Age 16 years or older

Exclusion Criteria

Patients
1. Pregnant or lactating females
2. Co-existing medical problems that would place the patient at significant risk of death due to GVHD or its sequelae
3. Human Immunodeficiency Virus (HIV) infection

Donors
1. Pregnant or lactating females
2. (assessed prior to apheresis) Platelets < 50x109/L

Study & Design

• Study Type: Interventional
• Study Design: Not specified