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Allogeneic Mesenchymal Precursor Cells (MPC) in Diabetic Nephropathy: A Randomized, Placebo-controlled, Dose
David K Packham1, Ian R Fraser2, Peter G Kerr3
1Melbourne Renal Research Group, Melbourne, Victoria, Australia; Department of Medicine, University of Melbourne, Melbourne, Victoria, Australia.
Ebiomedicine
|October 17, 2016
Summary
Mesenchymal precursor cells (MPC) were safe and well-tolerated in patients with diabetic nephropathy. This therapy showed potential to stabilize or improve kidney function, warranting further investigation in larger trials.
Area of Science:
- Nephrology
- Regenerative Medicine
- Clinical Trials
Background:
- Diabetic nephropathy is a leading cause of end-stage renal failure.
- Mesenchymal precursor cells (MPC) are being investigated for therapeutic potential in kidney disease.
Purpose of the Study:
- To assess the safety and tolerability of allogeneic bone-marrow derived MPC (rexlemestrocel-L) in patients with moderate to severe diabetic nephropathy.
- To explore the therapeutic effects of rexlemestrocel-L on renal function.
Main Methods:
- A multicenter, randomized, double-blind, placebo-controlled trial involving 30 patients with diabetic nephropathy.
- Patients received a single intravenous infusion of rexlemestrocel-L (150x10^6 or 300x10^6 cells) or placebo.
- Safety, tolerability, estimated glomerular filtration rate (eGFR), and measured GFR (mGFR) were assessed over 60 weeks.
Main Results:
- No acute adverse events or treatment-related serious adverse events were reported.
- No patients developed persistent donor-specific anti-HLA antibodies.
- A single infusion of rexlemestrocel-L showed trends towards stabilizing or improving eGFR and mGFR at 12 weeks post-infusion compared to placebo.
Conclusions:
- Rexlemestrocel-L is safe and well-tolerated in patients with diabetic nephropathy.
- The study suggests potential benefits of rexlemestrocel-L on renal function.
- Larger, powered trials are needed to confirm these findings.
