Summary of key work completed, May 2020:

  1. The project manager was appointed in April 2020
  2. A third draft of the study protocol is complete. Further amendments are awaiting the final lab healthy donor and AA Treg expansion data, and subsequent MHRA meeting outcome.
  3. Investigator Brochure (IB) and Investigational Medicinal Product Dossier (IMPD): Work on these two documents commenced on the appointment of the project manager on 27/4/20. A draft of the IB and IMPD from the ThRIL study, a King’s Health Partner liver transplant autologous Treg study using identical Good Manufacturing Practice (GMP) T reg production have been reviewed and these are currently being developed for the AA Treg study as it will follow similar GMP processes.
  4. As part of the IRAS application, patient information sheets, consent form, GP letter have all been written.
  5. Laboratory work had been progressing well until COVID-19 crisis. Further HD sample showed >20 fold expansion of Tregs in culture and with excellent suppressive ability. Once COVID-19 lockdown is lifted, further work on the AA samples will be able to continue, as planned.
  6. The latest manuscript on AA Tregs has just been accepted for publication by Blood journal, the top global haematology journal (“Lim SP et al. Treg sensitivity to FasL and relative IL-2 deprivation drive idiopathic aplastic anemia immune dysfunction”).

The impact of Covid-19

  1. Cessation of all laboratory work on the project as of 18/3/20
  2. Postponement of the MHRA meeting
  3. Subsequent delay in finalising the Study Protocol
  4. For the above reasons, no further work on the IRAS submission is possible at this stage
  5. The university lockdown continues until likely the beginning of July 2020, after which research work on the project should resume.