Enabling Advanced Medical Therapy in the Americas: A Pilot Study to Validate a "Ready-to-use" Intra-articular Formulation of Mesenchymal Stromal Cells, Aiming Toward an Effective and Scalable Treatment for Symptomatic Knee Osteoarthritis

PANLAR-II

The goal of this clinical trial is to compare a newly developed off-the-shelf cryopreserved "ready to inject" Mesenchymal Stem Cell (MSC) product with the usual MSC preparation the investigators have used in knee osteoarthritis (OA) patients. Since usual MSC therapy requires cell manipulation in GMP (Good Manufacturing Practices)-type facilities, this new formulation would enable wider access to Cell therapy and Multicentric clinical trials in areas devoid of expensive facilities and equipment.

2023-04-01

2024-12-01

2025-04-01

Not yet recruiting

Early phase I

60

Inclusion Criteria: * Symptomatic knee OA defined by grade 1-3 Kellgren-Lawrence radiographic changes in the targeted knee. * Daily pain at the affected joint for at least 3 months before inclusion Exclusion Criteria: * Bilateral symptomatic knee OA (only if the contralateral knee has more severe disease) * Meniscal rupture. * Condylar or tibial plateau generalized bone marrow edema on MRI * Major axial deviation defined by valgus (\>10°) or varus (5°) deformity of the involved leg * Use of oral or intra-articular steroids or hyaluronic acid in the past 6 months * Ipsilateral hip or ankle pain, local or systemic infection * Any form of secondary arthritis, previous malignancy, or body mass index ≥30.

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2023-03-02