New Medicines

Orbcel-M Progressive diabetic nephropathy in adults with type 2 diabetes


New molecular entity
Orbsen Therapeutics
Orbsen Therapeutics

Development and Regulatory status

Phase II Clinical Trials
Phase II Clinical Trials
Apr 19PI/II NEPHSTROM study is a European Union Horizon 2020-funded research project [3].


Second-generation stromal cell therapy based on allogeneic mesenchymal stromal cells (MSC) isolated from human bone marrow,
The prevalence of microalbuminuria in patients with type 2 diabetes at 10 years disease duration is approximately 20-25% [1].
Progressive diabetic nephropathy in adults with type 2 diabetes
Intravenous infusion

Trial or other data

Jul 21PI/II NEPHSTROM trial is still recruiting; timelines unchanged [7].
Sep 20PI/II NEPHSTROM trial continues to recruit, including at Belfast City Hospital and University Hospital Birmingham NHS Foundation Trust - Queen Elizabeth Medical Centre. Collection of safety primary outcome data is expected to complete in Jun 21; collection of efficacy outcomes should finish Dec 21 [6].
Dec 19NCT02585622 UK trial sites Belfast, Birmingham [5]
Apr 19Orbsen has identified a marker protein as a tool for selecting therapeutic stromal cells from the mixture of cells residing in the bone marrow (and also umbilical cord or fat tissue). Antibodies to this marker recognize a protein on the stromal cell surface and enables the isolation of a clearly defined population of nearly 100% pure stromal cells from the tissue of human donors. These selected cells can be expanded in culture to form many therapeutic doses and can be used allogeneically in patients (i.e. one donor, multiple unrelated recipients) [4].
Mar 18PI/II NEPHSTROM trial is recruiting & expects to complete collection of primary outcome data in Jun 20 [2].
Dec 17PI/II NEPHSTROM trial to evaluate the efficacy, safety, feasibility and tolerability of an allogeneic bone marrow-derived Mesenchymal Stromal Cell (MSC) therapy in patients with type 2 diabetes (T2D) and progressive diabetic kidney disease starts (NCT02585622). Evaluation of the number and severity of all pre-specified infusion-associated events and the overall number and frequency of adverse events are the defined primary endpoints of the trial. 48 patients will be recruited in Ireland, Italy, and the UK [2].