Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety.
Systemic Infusion of Autologous Adipose Tissue-Derived Mesenchymal Stem Cells in Peritoneal Dialysis Patients: Feasibility and Safety.
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DOI：
10.22074/cellj.2019.5591
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发表时间：
2019-01
期刊：
影响因子：
2
通讯作者：
Aghdami N
中科院分区：
文献类型：
--
作者：
Alatab S;Shekarchian S;Najafi I;Moghadasali R;Ahmadbeigi N;Pourmand MR;Bolurieh T;Jaroughi N;Pourmand G;Aghdami N
使用间充质干细胞（MSC）被认为是改善纤维化疾病的新治疗方法。本研究的目的是评估在预期腹膜纤维化的腹膜透析（PD）患者中全身输注自体脂肪组织来源的间充质干细胞（AD-MSC）的可行性和安全性。 这项研究是一项前瞻性、开放标签、非随机、无安慰剂的 I 期临床试验。病例组由 9 名符合条件的肾衰竭患者组成，他们有两年以上的 PD 病史。自体 AD-MSC 通过吸脂获得，并在良好的生产实践条件下进行扩增。患者通过肘静脉接受1.2±0.1×106细胞/kg的AD-MSC，然后在基线时间点随访六个月，然后在输注后随访3周、6周、12周、16周和24周。进行临床、生化和腹膜平衡测试（PET）以评估腹膜溶质转运参数的安全性和可能的变化。 参与者中没有发现严重的不良事件和导管相关的并发症。 14 例报告的轻微不良事件在支持治疗后具有自限性或消退。一名患者出现腹膜炎，另一名患者出现出口部位感染，这似乎与手术无关。 PET 检测到溶质跨腹膜转运速率显着降低（D/P cr=0.77 vs. 0.73，P=0.02）。 这项研究首次证明了 AD-MSC 在 PD 患者中的可行性和安全性，以及溶质转运积极变化的潜力。有必要进行更大样本、更长随访时间和随机盲对照组的进一步研究，以阐明 MSC 给药的最有效途径、频率和剂量（注册号：IRCT2015052415841N2）。
Using mesenchymal stem cells (MSCs) is regarded as a new therapeutic approach for improving fibrotic diseases. the aim of this study to evaluate the feasibility and safety of systemic infusion of autologous adipose tissue-derived MSCs (AD-MSCs) in peritoneal dialysis (PD) patients with expected peritoneal fibrosis. This study was a prospective, open-label, non-randomized, placebo-free, phase I clinical trial. Case group consisted of nine eligible renal failure patients with more than two years of history of being on PD. Autologous AD-MSCs were obtained through lipoaspiration and expanded under good manufacturing practice conditions. Patients received 1.2 ± 0.1×106 cell/kg of AD-MSCs via cubital vein and then were followed for six months at time points of baseline, and then 3 weeks, 6 weeks, 12 weeks, 16 weeks and 24 weeks after infusion. Clinical, biochemical and peritoneal equilibration test (PET) were performed to assess the safety and probable change in peritoneal solute transport parameters. No serious adverse events and no catheter-related complications were found in the participants. 14 minor reported adverse events were self-limited or subsided after supportive treatment. One patient developed an episode of peritonitis and another patient experienced exit site infection, which did not appear to be related to the procedure. A significant decrease in the rate of solute transport across peritoneal membrane was detected by PET (D/P cr=0.77 vs. 0.73, P=0.02). This study, for the first time, showed the feasibility and safety of AD-MSCs in PD patients and the potentials for positive changes in solute transport. Further studies with larger samples, longer follow-up, and randomized blind control groups to elucidate the most effective route, frequency and dose of MSCs administration, are necessary (Registration Number: IRCT2015052415841N2).