The ONE Study Cell Therapy Trial
Research type
Research Study
Full title
A Unified Approach to Evaluating Cellular Immunotherapy in Solid Organ Transplantation
IRAS ID
125254
Contact name
Rachel Hilton
Contact email
Sponsor organisation
King's Health Partners
Eudract number
2013-002099-42
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Research summary
Organ transplantation is a life-changing and, in many cases, life-saving treatment for patients with end-stage organ failure but in all patients transplant survival depends on life-long drug-based immunosuppression. Unfortunately, immunosuppressive drugs are associated with significant side effects such as increased risk of infection, cancer, hardening of the arteries and diabetes. A primary aim in transplantation is reduced reliance on long-term drug-based immunosuppression. Although the immune system is responsible for transplant rejection, it also contains cell populations that can suppress rejection responses and a wealth of animal data has shown that adoptive transfer of such cells can provide a route to long-term transplant survival without long-term immunosuppression. The ONE Study is an investigator-initiated exploratory study that will lay the foundations for cell-based immunotherapy in solid organ transplant recipients and perhaps allow for a reduction in the use of general immunosuppression. Achieving this goal would dramatically improve outcomes for transplant recipients and concurrently reduce the current high financial costs for the healthcare system, patients, families and overall society.
In the UK the ONE Study Cell Therapy Trial is a phase-I/II study in which outcomes for 6 patients at Guy’s & St. Thomas’ and 6 in Oxford receiving Treg therapy will be compared with results from historical controls and with data from a study (the Reference Group) carried out at the same centres in which kidney transplant recipients receive conventional standard-of-care therapy. Recruitment and treatment of 6 living-donor renal transplant pairs at each centre is feasible within the foreseen trial duration. It is expected that the majority of Reference Group patients at each centre will have been transplanted before recruitment to the Cell Therapy Trial begins. If continuation criteria are met at the end of the Treg Cell Therapy Trial and no safety concerns arise, it is anticipated that further clinical trials will follow.
REC name
South Central - Oxford A Research Ethics Committee
REC reference
13/SC/0568
Date of REC Opinion
7 Nov 2013
REC opinion
Favourable Opinion