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In our phase 2 trial, we found that cell therapy with a combination of growth-arrested neonatal keratinocytes and fibroblasts, without the need for a distinct tissue construct, significantly reduced wound size and led to greater complete closure in patients with refractory venous leg ulcers, with the optimum dose being 0.5xl06 cells/mL given every 14 days. Cell viability is one of several manufacturing release criteria for the product. After freezing, thawing, and transit through the spray device, about 80% of the cells retain viability (data on file). We agree with Guo-You Zhang and colleagues that viability is likely to be crucial for the success of the therapy.Regarding a representative figure, we felt it was important for our paper to provide all of the data for all groups tested, and we did not include a specific figure forthe identified optimum dose.
机译:在我们的2期试验中,我们发现,将生长停滞的新生儿角质形成细胞和成纤维细胞联合使用的细胞疗法,无需独特的组织结构,可显着减小伤口尺寸,并导致难治性静脉曲张性溃疡患者完全闭合,每14天给予0.5x106细胞/ mL的最佳剂量。细胞活力是该产品的几种制造释放标准之一。冷冻,解冻并通过喷雾器运输后,约80%的细胞保持活力(数据存档)。我们同意Guo-You Zhang及其同事的观点,即生存力可能对治疗的成功至关重要。关于一个有代表性的数字,我们认为为论文提供所有测试组的所有数据非常重要,我们做了不包括确定的最佳剂量的具体数字。

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