dm+d

Unassigned

New Medicines

Kidney transplant rejection

Information

New molecular entity
Medeor
Medeor

Development and Regulatory status

None
None
Phase III Clinical Trials
Sep 20FDA grants regenerative medicine advanced therapy (RMAT) designation to MDR 101 for the prevention of kidney transplant rejections [3].

Category

A formulation of organ donor-derived CD34+ haematopoietic stem and progenitor cells and CD3+ T cells, manufactured from transplant kidney donor-derived stem cells, engineered to create a unique formulation of multiple different haematopoietic cell types
The UK has a relatively high rate of kidney transplants compared to most European Union nations. With a rate of 54.5 kidney transplants per million population in 2019. This was the fourth highest in the EU. The only countries with a higher rate than the UK in this year were the Netherlands, France and Spain [1].
Kidney transplant rejection
Intravenous infusion

Trial or other data

Sep 20PIII trial (NCT03363945) is recruiting [2].
Jan 18PIII trial to evaluate the safety and efficacy of cellular immunotherapy with MDR 101 for induction of functional immune tolerance, in recipients of human leukocyte antigen (HLA)-matched, living donor kidney transplants starts (MDR101MLK; NCT03363945). The open label trial intends to enrol 30 adults in the US and Canada. The purpose of the current Phase 3 study is to demonstrate the efficacy and safety of MDR-101 for the induction of transplant immune tolerance in a prospective, randomized, multicenter clinical trial. MDR-101 is intended to induce mixed lymphohematopoietic chimerism and donor specific immune tolerance in order to preserve transplant kidney function, avert transplant kidney rejection, and eliminate the cumulative and serious side effects associated with immunosuppressive drugs. Primary outcome is functional immune tolerance; collection of these data is due to complete Jan 22 [2].