ICH GEPID Study Version 1.0

  • Research type

    Research Study

  • Full title

    Gene Editing in Primary Immunodeficiency

  • IRAS ID

    296973

  • Contact name

    Adrian Thrasher

  • Contact email

    a.thrasher@ucl.ac.uk

  • Sponsor organisation

    Institute of Child Health

  • Duration of Study in the UK

    4 years, 0 months, 0 days

  • Research summary

    Primary Immunodeficiencies affect roughly 1 in 15,000 people in the United Kingdom. These diseases cause frequent and serious infections. Genetic causes are increasingly being identified in patients. Conventional therapy depends on the individual condition but can involve life-long infusions of immunoglobulin, prophylactic antibiotics and stem cell transplants. All these treatments come with risks and often patients will still have infections. Currently a safe and definitive treatment is lacking.

    Recent progress in gene therapy has led to promising treatments in several Immunodeficiencies where the causative genetic mutation has been identified. This involves putting the correct gene into cells. However, conventional gene therapy has limitations as we cannot control where the gene is inserted.
    An alternative novel approach is to use accurate gene editing technology in order to insert the correct gene into the location it is normally found in or directly repair a mutation. This project will be a pre-clinical study to establish this technique for the treatment of Primary Immunodeficiencies.
    We would like to trial our technique in cells from patients to see if we can restore their ability to function correctly. We will compare these corrected cells with stem cells from patients without the disease. In order to test the corrected cells and compare them to stem cells from healthy donors, we will inject them into mice which don’t have an immune system and monitor them over several months to determine if their immune system is restored. All these experiments will follow strict Home Office rules which are designed to minimise distress caused to the animals.

  • REC name

    North West - Liverpool Central Research Ethics Committee

  • REC reference

    21/NW/0240

  • Date of REC Opinion

    1 Nov 2021

  • REC opinion

    Further Information Favourable Opinion