Status:

TERMINATED

Suicide Gene Therapy Trial

Lead Sponsor:

Great Ormond Street Hospital for Children NHS Foundation Trust

Conditions:

Haploidentical Stem Cell Transplantation

Eligibility:

All Genders

Up to 16 years

Phase:

PHASE1

PHASE2

Brief Summary

Bone marrow or blood stem cell transplantation is used to treat a wide range of life-threatening conditions. T lymphocytes carried in the graft have powerful beneficial effects and play a vital role i...

Eligibility Criteria

Inclusion

  • Patients with primary immunodeficiencies, haematological malignancies or metabolic disorders at GOSH (children of both sexes, aged 0 to 16 years) undergoing haploidentical transplant
  • Both patient and donor must give informed consent in writing.
  • The donor must be willing, able and available for donation of T cells by collection of whole blood or leukapheresis.
  • The patient should be free of serious intercurrent illness.

Exclusion

  • Donor unfit or unavailable
  • Donor positive for Hepatitis B or C, or HTLV-1, or HIV
  • Patient receiving Ganciclovir, Aciclovir, Cidofovir a result of active CMV, adenovirus, varicella zoster or herpes simplex infection infection
  • GVHD ≥ grade II before infusion of gene modified T cells
  • Serious intercurrent illness

Key Trial Info

Start Date :

January 1 2011

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

January 1 2013

Estimated Enrollment :

2 Patients enrolled

Trial Details

Trial ID

NCT01204502

Start Date

January 1 2011

End Date

January 1 2013

Last Update

September 18 2013

Active Locations (1)

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Page 1 of 1 (1 locations)

1

Great Ormond Street Hospital for Children NHS Trust

London, United Kingdom, WC1N 3JH