The trial is now listed on the Dutch trial register:
https://onderzoekmetmensen.nl/en/trial/53310
I find the background comments interesting, especially since the person leading the trial is also currently serving as the Node Director at the Novo Nordisk Foundation Center for Stem Cell Medicine.
Background summaryKidney transplantation has improved survival and quality of life for patients with end-stage renal disease. However, despite advances in immunosuppressive therapy, long- term allograft survival outcomes have not improved over the last decade. There is a clear need for therapeutic alternatives because
1) patients may not respond to existing therapeutic choices,
2) they do not show an improvement of the fibrosis reaction
3) they do not show an effect on long term survival,
4) they may develop immunosuppression induced serious (sometimes fatal) side effects and toxicities.
LUMC has conducted 3 trials using bone-marrow derived mesenchymal stromal cells (BM-MSC) showing both safety and efficacy of their use in the setting of kidney transplantation. MSC isolation and culture from both autologous and allogeneic sources is being hampered by cellular heterogeneity and replicative senescence. Generation of MSC from induced pluripotent stem cells (iPSC) so called MCA-derived MSC may circumvent these limitations. MCA-derived MSC have recently been tested in clinical trials and found to be safe and more cost effective than traditional MSC. Given the benefits of MCA-derived MSC we propose to test whether MCA-derived MSC are safe in the setting of kidney transplantation in a clinical study. The TRITON study in which MSC therapy was shown to allow withdrawal of the nephrotoxic calcineurin inhibitor tacrolimus, will form the backbone for this clinical trial in which 16 patients will receive MCA-derived MSC combined with tacrolimus reduction to study safety and immunological efficacy of MCA-derived MSC therapy.
Study design
A non-randomized, open-label, non-blinded, prospective, single-center clinical phase I/IIb study to investigate whether MCA-derived MSC are safe by assessing the incidence of adverse events and BPAR/graft loss after MCA-derived MSC treatment.
Intervention
All patients will receive steroids according to the LUMC protocol and induction treatment with basiliximab at day 0 and 4 (20 mg intravenously). Patients will receive either 1 or 2 doses of 2x10^6 (+/- 10%) MCA-derived MSC/kg - the first at week 6 and the second at week 7 after transplantation.
Recruitment
NL
Recruitment status : Pending
Start date (anticipated) : 01-07-2023
Enrollment : 16
Type : Anticipated
(20min delay)