Clinical studies are studying patients with diabetes and advanced chronic kidney disease
Orbsen Therapeutics, a specialist in stromal cell immunotherapy, has announced positive results from the EU Horizon 2020-funded Nephstrom clinical trial in diabetic kidney disease (DKD).
This study is a double-blind, randomized, placebo-controlled Phase 1/2a study evaluating the tolerability, safety and preliminary efficacy of Orbcel. This therapy is an off-the-shelf allogeneic bone marrow-derived mesenchymal stromal cell immunotherapy and the study includes adult patients with type 2 diabetes and advanced DKD.
Orbcel is a proprietary formulation of highly purified immunomodulatory stromal cells, and research on its efficacy was led by the Mario Negri Institute for Pharmacological Research IRCCS.
Interim results found the safety and tolerability profile of Orbcel to be similar to placebo, and no treatment-related side effects were observed with stromal cell infusion.
On the other hand, a single intravenous injection of Orbcel was associated with a statistically significant maintenance of renal function over baseline. Blood markers monitored also suggested that this treatment was associated with evidence of stabilization of the proportion of regulatory T cells in the blood.
Enrollment in the second dose-level patient cohort was completed late last year, and interim results are expected to be available in the second half of this year
Orbsen’s Chief Scientific Officer, Dr. Stephen Elliman, said:
“Our goal with Orbcel is to reduce systemic inflammation and improve kidney function so that these patients do not require dialysis or kidney transplantation. This makes it an important disease target for Orbsen and our technology,” he added.
Professor Giuseppe Lemuzzi, Director of the IRCCS at the Mario Negri Institute of Pharmacology, concludes: As a sodium-glucose transporter 2 inhibitor that has been shown to slow the decline of renal function.”
DKD affects 30-40% of adults with type 2 diabetes and accounts for approximately 40% of all patients with end-stage renal disease. It also greatly increases the risk of heart and blood vessel disease.
