Efficacy and safety of adult human bone marrow-derived, cultured, pooled, allogeneic mesenchymal stromal cells (Stempeucel): preclinical and clinical trial in osteoarthritis of the knee joint

この研究はハイインパクトの可能性があります。 OEのAI駆動型ハイインパクト指標は、論文が掲載されたジャーナルと論文自体の科学的内容の両方からのシグナルを統合することで、論文が持つ可能性の高い影響力を推定します。 最先端の自然言語処理を用いて開発されたOEハイインパクトモデルは、ジャーナルのインパクトファクターのみよりも、研究の将来の引用実績をより正確に予測します。 これにより、臨床的に意義のある研究をより早く認識することが可能になり、読者は将来の診療を形成する可能性が最も高い論文に集中することができます。

60 patients with Kellgren-Lawrence grade II-II knee osteoarthritis were randomized to one of five treatments: bone marrow--derived allogeneic mesenchymal stromal cell injection at either a 25, 50, 75, or 150 million cell dose, or placebo injection. At each dose level, randomization was conducted at a 2:1 ratio of intervention to placebo; therefore a total of 10 patients were administered at each dose level, and 20 patients overall were administered placebo. Analyses were separated by lower and higher dose levels, with the patients of the placebo groups at the first two dose levels treated as one group (placebo group 1), and the patients of the placebo groups at the last two dose levels treated as one group (placebo group 2). The 25M and 50M dose groups were analyzed relative to placebo group 1, and 75M and 150M dose groups were analyzed relative to placebo group 2. Overall, incidence of adverse events were similar between treatment and placebo groups, with the most common AEs documented related to arthralgia and injection site pain. Only results of the comparisons between the 25M, 50M, and placebo 1 group were reported. Despite the greatest changes from baseline after 12 months documented in the 25M group for pain scores and results on the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), between-group comparisons yield non-significant differences, with the exception of WOMAC stiffness scores.