Bone Marrow Mesenchymal Stromal Cell Treatment in Patients with Osteoarthritis Results in Overall Improvement in Pain and Symptoms and Reduces Synovial Inflammation

Chahal J, Gómez-Aristizábal A, Shestopaloff K, et al. · Stem Cells Translational Medicine

A phase I/IIa open-label dose escalation, 12 patients with Kellgren-Lawrence grade 3-4 knee osteoarthritis in three groups of four, given autologous culture-expanded bone-marrow mesenchymal stromal cells at 1, 10 or 50 million cells, followed to 24 months. Adverse events were minor and transient. KOOS pain, symptoms and quality of life and WOMAC stiffness improved significantly against baseline, and all four patients in the 50 million group reached the minimal clinically important difference of 10 points on most patient-reported scores. Synovial inflammation and cartilage catabolic markers fell in a dose-dependent way. The imaging did not move: WORMS and T2 scores did not change relative to baseline.

Population

12 patients with late-stage (KL 3-4) knee OA, phase I/IIa dose-escalation

Intervention

Autologous culture-expanded BM-MSCs at 1, 10, or 50 million cells

Comparator

None (open-label dose escalation)

Limitations

No control arm and no blinding, with four patients per dose group, so every improvement is measured against baseline in an open-label trial of an injected procedure. Biomarker endpoints are mechanistic rather than clinical proof. The authors carry industry disclosures.