Department of Plastic Surgery and Burn Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Department of Plastic Surgery and Burn Treatment, Copenhagen University Hospital, Rigshospitalet, Copenhagen, Denmark.
Burns. 2023 May;49(3):633-645. doi: 10.1016/j.burns.2022.04.020. Epub 2022 Apr 26.
Mesenchymal stem cell (MSC)-therapy is increasingly being evaluated in clinical trials. Dermal delivery is not only time consuming but also unreliable, potentially hampering the therapeutic result. Therefore, qualification of cell delivery protocols is essential. This study evaluated a clinically relevant automated multi-needle injection method for cutaneous MSC-therapy, allowing the skin to be readily and timely treated, by assessing both the cellular health post-ejection and dermal delivery.
Following dispensation through the injector (31 G needles: 9- or 5-pin) the cellular health and potency (perceived- and long-term (12 h) viability, recovery, metabolism, adherence, proliferation and IDO1-expression) of adipose-derived stem cells (10-20-50 ×10 cells/ml) were assessed in vitro in addition to dermal delivery of solution in human skin.
No significant detrimental effect on the perceived cell viability, recovery, metabolism, adherence or IDO1-expression of either cell concentration was observed. However, the overall long-term viability and proliferation decreased significantly regardless of cell concentration, nonetheless marginally. An injection depth above 1.0 mm resulted in all needles piercing the skin with dermal delivery from up to 89% needles and minimal reflux to the skin surface, and the results were confirmed by ultrasound and histology.
The automated injector is capable of delivering dermal cell-doses with an acceptable cell quality.
间充质干细胞（MSC）疗法越来越多地在临床试验中得到评估。真皮递送不仅耗时，而且不可靠，可能会影响治疗效果。因此，细胞递送方案的鉴定是至关重要的。本研究评估了一种临床相关的自动化多针注射方法，用于皮肤 MSC 治疗，通过评估注射后细胞的健康状况和真皮递送，使皮肤能够得到及时和容易的治疗。
通过注射器（31G 针头：9 或 5 针）分配后，评估脂肪来源干细胞（10-20-50×10 个细胞/ml）的细胞健康和效力（感知和长期（12 小时）活力、恢复、代谢、粘附、增殖和 IDO1 表达），以及在人体皮肤中的溶液真皮递送。
无论细胞浓度如何，都没有观察到对感知细胞活力、恢复、代谢、粘附或 IDO1 表达的显著不利影响。然而，无论细胞浓度如何，整体长期活力和增殖都显著下降，尽管只是略有下降。注射深度超过 1.0 毫米会导致所有针头刺穿皮肤，多达 89%的针头进行真皮递送，且回流到皮肤表面的量最小，这些结果通过超声和组织学得到了证实。
自动化注射器能够以可接受的细胞质量递送达皮细胞剂量。
