Transplantation of NiCord®, Expanded Cord Blood Stem Cells
Research type
Research Study
Full title
A Multicenter, Randomised, Phase III Registration Trial of Transplantation of NiCord®, Ex Vivo Expanded, Umbilical Cord Blood-derived, Stem and Progenitor Cells, versus Unmanipulated Umbilical Cord Blood for Patients with Hematological Malignancies
IRAS ID
245499
Contact name
Emma Nicholson
Contact email
Sponsor organisation
Gamida Cell Ltd
Eudract number
2016-000704-28
Clinicaltrials.gov Identifier
Duration of Study in the UK
3 years, 0 months, 0 days
Research summary
Treatments for blood cancer involve chemotherapies/radiations and blood and marrow transplantations (BMT). Transplantation relies on the infusion of a sufficient number of hematopoietic stem/progenitor cells (early blood cells in the bone marrow that develop into red, white blood cells and platelets), with the ability to home in the bone marrow and develop into red, white blood cells and platelets quickly. Matched stem/progenitor cells can be sourced from related donors or unrelated donors. Although the related donors option offers the best results, due to lack of suitable matches, over two third of patients are awaiting transplant. In case related donors are not found, unrelated grafts are searched through databases. The medical need for suitable grafts is still insufficiently met because the lower number of stem cells compared to adult donor may delay blood cell recovery, which can result in an increased occurrence or higher severity of infections after transplantation. These infections sometimes lead to substantial organ damage, which may be irreversible, and also death. The delay is also a substantial burden on the NHS.
NiCord® is a stem/progenitor cell-based product composed of matched donor's cells multiplied in a laboratory from one entire unit of umbilical cord blood. Preliminary data from trials in humans conducted by the sponsor indicate that NiCord® may significantly decrease the blood cells recovery time, hence reducing the risks mentioned above.
The study will assess the safety and efficacy of the transplant of NiCord® compared to one or two unmanipulated cord blood units (patients from 12 to 65 years old will be randomised to a 1:1 ratio). 120 patients will be recruited in the world.
The primary objective of the trial is to verify how fast the blood cells from the patients treated with NiCord® will recover from the transplant.REC name
South Central - Oxford A Research Ethics Committee
REC reference
18/SC/0395
Date of REC Opinion
28 Nov 2018
REC opinion
Further Information Favourable Opinion