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<p>Knee osteoarthritis is a degenerative joint disease, with no fundamental cure beyond pain relief and anti-inflammation. This phase I, multicenter, open-label, dose-escalation trial evaluated the safety, tolerability, and preliminary efficacy of OSCA, an intra-articular injection co-formulation of osiramestrocel (allogeneic mesenchymal stromal cells) and cartilage acellular matrix, in patients with Kellgren–Lawrence (K&amp;L) grade 2 or 3 knee osteoarthritis. Twelve patients received a single intra-articular injection of OSCA at low (2.5 × 10<sup>7</sup> cells, <i>n</i> = 3), mid (5.0 × 10<sup>7</sup> cells, <i>n</i> = 3), or high (1.0 × 10<sup>8</sup> cells, <i>n</i> = 6) doses; cell concentration was 3.3 × 10<sup>7</sup> cells/ml for all cohorts, and cartilage acellular matrix was 60 mg (40 mg/ml). The primary end point was safety, assessed by dose-limiting toxicities and TEAEs. Secondary end points included Visual Analog Scale (VAS), International Knee Documentation Committee (IKDC), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART), Whole-Organ Magnetic Resonance Imaging Score (WORMS), and K&amp;L grading over 24 weeks. OSCA was well tolerated, with no dose-limiting toxicities and mild-to-moderate TEAEs in 25.0% (3/12) of patients. At 24 weeks, mid-dose and high-dose groups showed numerically greater improvement in pain and function than the low-dose group (<i>P</i> &lt; 0.05), with up to 91.3% reduction in VAS (<i>P</i> = 0.002) and 102.7% IKDC (<i>P</i> = 0.005). MRI outcomes showed efficacy signals: MOCART total scores improved in 70% of patients, WORMS cartilage integrity improved in 50%, and K&amp;L grades remained stable in 80%. Overall, these findings support the feasibility and tolerability of a single OSCA injection, with exploratory efficacy in both clinical and MRI outcomes.</p>

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First-in-human and multicenter phase I study of OSCA therapy for knee osteoarthritis

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年5月1日

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  • Dae Keun Suh,
  • Sang Hak Lee,
  • Yohan Bae,
  • Hee-Jin Kang,
  • Seunghee Lee,
  • Mijin Kim,
  • JongCheon Na,
  • Ali Mobasheri,
  • Kyung-Sun Kang,
  • Kyoung Ho Yoon

摘要

Knee osteoarthritis is a degenerative joint disease, with no fundamental cure beyond pain relief and anti-inflammation. This phase I, multicenter, open-label, dose-escalation trial evaluated the safety, tolerability, and preliminary efficacy of OSCA, an intra-articular injection co-formulation of osiramestrocel (allogeneic mesenchymal stromal cells) and cartilage acellular matrix, in patients with Kellgren–Lawrence (K&L) grade 2 or 3 knee osteoarthritis. Twelve patients received a single intra-articular injection of OSCA at low (2.5 × 107 cells, n = 3), mid (5.0 × 107 cells, n = 3), or high (1.0 × 108 cells, n = 6) doses; cell concentration was 3.3 × 107 cells/ml for all cohorts, and cartilage acellular matrix was 60 mg (40 mg/ml). The primary end point was safety, assessed by dose-limiting toxicities and TEAEs. Secondary end points included Visual Analog Scale (VAS), International Knee Documentation Committee (IKDC), Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART), Whole-Organ Magnetic Resonance Imaging Score (WORMS), and K&L grading over 24 weeks. OSCA was well tolerated, with no dose-limiting toxicities and mild-to-moderate TEAEs in 25.0% (3/12) of patients. At 24 weeks, mid-dose and high-dose groups showed numerically greater improvement in pain and function than the low-dose group (P < 0.05), with up to 91.3% reduction in VAS (P = 0.002) and 102.7% IKDC (P = 0.005). MRI outcomes showed efficacy signals: MOCART total scores improved in 70% of patients, WORMS cartilage integrity improved in 50%, and K&L grades remained stable in 80%. Overall, these findings support the feasibility and tolerability of a single OSCA injection, with exploratory efficacy in both clinical and MRI outcomes.