Safety and efficacy of an allogeneic adipose-derived mesenchymal stem cell preparation in the treatment of knee osteoarthritis: A Phase I/IIa randomised controlled trial.

To assess the safety and efficacy of an allogeneic adipose-derived mesenchymal stem cell preparation (MAG200) in the treatment of knee osteoarthritis over 12 months. A single-centre, double-blind, ascending dose, randomised controlled trial. 40 participants with moderate knee osteoarthritis were randomised to receive a single intra-articular injection of MAG200 (dose cohorts:10, 20, 50, 100 ​× ​10 Treatment was well tolerated with no treatment-related serious adverse events. MAG200 cohorts reported a greater proportion of responders than placebo and demonstrated clinical and statistically significant improvement in pain and clinically relevant improvement in all KOOS subscales. MAG200 demonstrated a reproducible treatment effect over placebo, which was clinically relevant for pain in the 10 ​× ​10 This early-phase study provides supportive safety and efficacy evidence to progress MAG200 to later-stage trial development. ACTRN12617001095358/ACTRN12621000622808.

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Déclaration de conflit d'intérêts

JF is the Chief Medical Officer of Magellan Stem Cells Pty Ltd, holds stocks or options in Magellan Stem Cells Pty Ltd and is the Current Chair of the Magellan Stem Cells Medical and Scientific Advisory Board. MC declares no conflicts of interest. JW declares no conflicts of interest. KS is an employee of Magellan Stem Cells Pty Ltd. YW is the recipient of National Health and Medical Research Council of Australia Translating Research into Practice Fellowship (APP1168185). AS declares no conflicts of interest. FMC is the recipient of Investigator Grant from the National Health and Medical Research Council of Australia and reports receipt of institutional payment from Magellan Stem Cells Pty Ltd for undertaking the MRI measurements.