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Randomized Controlled Trial
. 2025 Feb;27(2):188-200.
doi: 10.1016/j.jcyt.2024.09.005. Epub 2024 Oct 16.

Efficacy of a single dose of cryopreserved human umbilical cord mesenchymal stromal cells for the treatment of knee osteoarthritis:a randomized, controlled, double-blind pilot study

Omar Amado Pico  1 , Francisco Espinoza  2 , María Ignacia Cádiz  3 , Claudia L Sossa  4 , Silvia M Becerra-Bayona  5 , María C Canencio Salgado  5 , Javier Eduardo Rengifo Rodríguez  5 , Oscar Fabian Valdivieso Cárdenas  5 , Johanna Marcela Quintero Cure  5 , Maroun Khoury  6 , Martha L Arango-Rodríguez  7
Affiliations
Randomized Controlled Trial

Efficacy of a single dose of cryopreserved human umbilical cord mesenchymal stromal cells for the treatment of knee osteoarthritis:a randomized, controlled, double-blind pilot study

Omar Amado Pico et al. Cytotherapy. 2025 Feb.

Abstract

Background: Knee osteoarthritis (OA) is the most prevalent degenerative musculoskeletal disorder, which is particularly common in older population. While conventional treatments have limited effectiveness, the development of more effective therapeutic strategies is necessary to address this primary source of pain and disability. Umbilical cord mesenchymal stromal cells (UC-MSCs) offer a promising therapeutic approach for treating knee OA.

Aim: This randomized, prospective, double-blind and controlled pilot study was carried out to evaluate and compare the safety and therapeutic efficacy of a single intra-articular injection of a standardized product CellistemOA (5 × 106 ± 5 × 105 UC-MSCs), vs. triamcinolone (a synthetic corticosteroid) (10 mg/mL) in thirty patients with symptomatic knee OA (Kellgren-Lawrence grade II or III).

Methods: The outcomes included changes in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores based on a Likert scale, numerical rating score (NRS) for pain, Magnetic Resonance Imaging (MRI), and quality of life (SF-36 questionnaire), from baseline and throughout 12-months of follow-up.

Results: Patients treated with CellistemOA showed significant improvement in WOMAC score (including the three subscale scores (pain, stiffness and function), NRS in pain, and SF-36 profile from baseline to 12 months (p < 0.05) compared to the triamcinolone group, and no severe adverse events were reported. There were no significant differences in MRI WORMS scores between the two groups. However, patients who received the cellular treatment experienced a significant improvement in their SF-36 profile (p < 0.05).

Conclusions: This pilot study revealed that a single dose of CellistemOA is safe and superior to the active comparator in knee OA at 1-year of follow-up, making it a compelling therapeutic alternative to treat symptomatic OA patients.

Keywords: cell therapy; knee osteoarthritis; regenerative medicine; umbilical-cord-derived mesenchymal stromal cells.

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Conflict of interest statement

Declaration of competing interest Maroun Khoury is the chief scientific officer of Cells for Cells, Regenero and EVast Bio. He reports receiving grants from ANID, during the conduct of the study and other from Cells for Cells. In addition, Dr. Khoury is the inventor of patents related to mesenchmal stromal cellincluding a patent WO2014135924A1 pending, a patent WO2017064670A2 pending, a patent WO2017064672A1 pending, and a patent WO/2019/051623 pending. Maria-Ignacia Cadiz and Francisco Espinoza received stipends from Cells for Cells. The other authors declare that no conflict of interest could be perceived as prejudicing the impartiality of the research reported.

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