The article reports a prospective, open‑label phase I/II trial evaluating the safety and efficacy of allogeneic, GMP‑expanded Wharton jelly mesenchymal stem cells (WJMSCs) injected intra‑articularly under real‑time ultrasound guidance in patients with advanced knee osteoarthritis (KOA, Kellgren‑Lawrence grade III–IV). Sixteen adult participants (25 knees) received two intra‑articular doses of WJMSCs (≈0.6 × 10⁶ cells/kg per dose, administered one month apart). Patients were followed for 48 months for safety and for 12 months for magnetic resonance imaging (MRI) outcomes; clinical outcomes were assessed with the normalized Knee Injury and Osteoarthritis Outcome Score (KOOS) at 6, 12 and 48 months. Safety was excellent: no serious long‑term adverse events; transient mild‑moderate pain, one effusion, and one superficial phlebitis were the only reported events. Clinically, KOOS improved markedly (baseline ≈43, rising to ≈69 at 6 months and ≈77–79 at 12–48 months; p < 0.0001). MRI at 12 months showed statistically significant reductions in cartilage loss, osteophyte formation, bone‑marrow lesions, effusion and synovitis (p < 0.01) and a highly significant improvement in sub‑chondral sclerosis (p < 0.0001). The study concludes that intra‑articular WJMSC therapy is safe and potentially disease‑modifying, producing sustained functional improvement and structural MRI benefits, but acknowledges limitations (small sample, open‑label design, lack of long‑term MRI). The authors call for larger, double‑blind, placebo‑controlled trials.
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Rationale for Using Wharton Jelly MSCs in Advanced Knee Osteoarthritis
Discussion of KOA prevalence, pathophysiology, limitations of current pharmacologic and surgical options, and the biological promise of umbilical‑cord‑derived MSCs for cartilage regeneration and immunomodulation.