| Autor: |
Brian J. Cole, Joshua T. Kaiser, BS, Kyle R. Wagner, BS, Andreas H. Gomoll |
| Jazyk: |
angličtina |
| Rok vydání: |
2022 |
| Předmět: |
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| Zdroj: |
Journal of Cartilage & Joint Preservation, Vol 2, Iss 1, Pp 100037- (2022) |
| Druh dokumentu: |
article |
| ISSN: |
2667-2545 |
| DOI: |
10.1016/j.jcjp.2021.100037 |
| Popis: |
Introduction: Knee osteoarthritis treatments that functionally restore diseased/damaged cartilage are limited. Objective: To evaluate the safety and effectiveness of allogeneic, human, umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) + 4% hyaluronate composite for knee cartilage defects. Methods: In a 24-month, open-label, non-randomized phase 1/2a study, adults ≥18 years with single, full-thickness, ICRS grade 3 to 4 knee cartilage defects were recruited sequentially based on initial defect size (Dose A: 2-5 cm2; Dose B: >5 cm2). The hUCB-MSCs composite (0.25 × 107 cells/cm2) was surgically implanted into the defects. Safety (adverse events [AEs] and dose-limiting toxicities) was the primary objective, and efficacy was secondary. Results: Twelve patients (mean 38 years; 83% male; BMI 27.6 kg/m2) completed the study. All patients reported ≥1 treatment-emergent AE (TEAE): 42 with Dose A (n = 6); 27 with Dose B (n = 6); most common were decreased range of motion (100%) and arthralgia (92%). Seven patients (58%) had 10 treatment-related TEAEs. No discontinuations due to TEAEs, serious AEs, or deaths were reported. There were no dose-limiting toxicities; maximum tolerated dose was established as 2.0 × 107 cells. The IKDC score and other knee function and pain scores significantly improved from baseline to months 12 and 24. Clinically significant abnormal MRI findings declined from 91.7% (n = 11) at baseline to 16.7% (n = 2) at month 24. Conclusion: hUCB-MSCs + 4% hyaluronate composite implantation appears to be safe over 24 months in US patients with ICRS grade 3 to 4 knee cartilage defects, with improvements in function, pain, and cartilage repair evidence. |
| Databáze: |
Directory of Open Access Journals |
| Externí odkaz: |
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