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May 1, 2026

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

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

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Key Points

This study aims to evaluate the safety and exploratory efficacy of OSCA therapy for knee osteoarthritis.
Multicenter phase I trial assessing safety through adverse events over 24 weeks.
Evaluated secondary outcomes including VAS, IKDC, MOCART, WORMS, and K&L grading.
Participants received a single injection of varying OSCA doses.
OSCA showed no dose-limiting toxicities with mild-to-moderate TEAEs in 25.0% of patients.
Mid and high-dose groups had a 91.3% reduction in VAS (P = 0.002) and 102.7% improvement in IKDC (P = 0.005).
MRI outcomes indicated improvements: 70% of patients had better MOCART scores, and K&L grades remained stable in 80%.

Implication

Shows exploratory efficacy and safety of OSCA therapy in knee osteoarthritis, supporting its further development.

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Cite This Study

Suh et al. (2026) studied this question.

synapsesocial.com/papers/69f6e6648071d4f1bdfc70ca https://doi.org/10.1038/s12276-026-01728-w

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Keep reading

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

1Adipose Mesenchymal Stromal Cell-Based Therapy for Severe Osteoarthritis of the Knee: A Phase I Dose-Escalation TrialHuman Clinical Trial · 2016 · 511 citations
2Safety and Efficacy of Hybrid Cooperative Complexes of Sodium Hyaluronate and Sodium Chondroitin for the Treatment of Patients with Symptomatic Knee Osteoarthritis2024 · 11 citations
3Intra‐articular and intra‐osseous expanded adipose‐derived stromal cell injections for knee osteoarthritis‐related bone marrow lesions yield promising outcomes: Preliminary results in 16 athletesCohort Study · 2026 · 2 citations
4Multiple intra-articular injections of umbilical cord mesenchymal stem cells in treating severe knee osteoarthritis: a triple-blind randomized controlled trialRCT · 2026
5Intra-articular allogeneic adipose-derived mesenchymal stromal cell injections for stage III knee osteoarthritis: a double-blind placebo-controlled trial with 60-month follow-up.RCT · 2026

Intra-articular injections with Carboxymethyl-Chitosan in patients affected by knee osteoarthritis non-responders to hyaluronic acid: a pilot study2024
Efficacy of Stromal Vascular Fraction Treatment for Knee Osteoarthritis: A Single-Arm Experimental Trial2025
Impact of Kellgren–Lawrence grade on clinical outcomes following adipose-derived stem cell therapy for knee osteoarthritis: A propensity score–matched retrospective cohort study2026

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