Department of Geriatrics, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China.
Department of General Medicine, Shanghai East Hospital, Tongji University School of Medicine, Shanghai, 200120, China.
Stem Cell Res Ther. 2024 Apr 29;15(1):122. doi: 10.1186/s13287-024-03707-2.
Mesenchymal stem cells (MSCs) hold a great promise for cell-based therapy in the field of regenerative medicine. In this study, we aimed to evaluate the safety and efficacy of intravenous infusion of human umbilical cord-derived MSCs (HUC-MSCs) in patients with aging frailty.
In this randomized, double-blind, placebo-controlled trial, participants diagnosed with aging frailty were randomly assigned to receive intravenous administrations of HUC-MSCs or placebo. All of serious adverse events and AEs were monitored to evaluate the safety of treatment during the 6-month follow-up. The primary efficacy endpoint was alteration of physical component scores (PCS) of SF-36 qualities of life at 6 months. The secondary outcomes including physical performance tests and pro-inflammatory cytokines, were also observed and compared at each follow-up visits. All evaluations were performed at 1 week, 1, 2, 3 and 6 months following the first intravenous infusion of HUC-MSCs.
In the MSCs group, significant improvements in PCS of SF-36 were observed from first post-treatment visit and sustained throughout the follow-up period, with greater changes compared to the placebo group (p = 0.042). EQ-VAS scores of MSCs group improved significantly at 2 month (p = 0.023) and continued until the end of the 6-month visit (p = 0.002) in comparison to the placebo group. The timed up and go (TUG) physical performance test revealed significant group difference and showed continual enhancements over 6 months (p < 0.05). MSC transplantation improved the function of 4-m walking test (4MWT) compared with the placebo group with a decrease of 2.05 s at 6 months of follow-up (p = 0.21). The measurement of grip strength revealed group difference with MSCs group demonstrating better performance, particularly at 6 months (p = 0.002). Inflammatory cytokines (TNF-α, IL-17) exhibited declines in MSCs group at 6 months compared to the placebo group (p = 0.034 and 0.033, respectively). There was no difference of incidence of AEs between the two groups.
Intravenous transplantation of HUC-MSCs is a safe and effective therapeutic approach on aging frailty. The positive outcomes observed in improving quality of life, physical performance, and reducing chronic inflammation, suggest that HUC-MSC therapy may be a promising potential treatment option for aging frailty.
Clinicaltrial.gov; NCT04314011; https://clinicaltrials.gov/ct2/show/NCT04314011 .
间充质干细胞（MSCs）在再生医学领域的细胞治疗中具有巨大的应用前景。在这项研究中，我们旨在评估静脉输注人脐带来源的间充质干细胞（HUC-MSCs）治疗衰老脆弱患者的安全性和疗效。
这是一项随机、双盲、安慰剂对照试验，将被诊断为衰老脆弱的患者随机分为接受 HUC-MSCs 或安慰剂静脉输注。在 6 个月的随访期间，监测所有严重不良事件和 AE，以评估治疗的安全性。主要疗效终点是 6 个月时 SF-36 生活质量的身体成分评分（PCS）的变化。次要结局包括身体表现测试和促炎细胞因子，也在每次随访时进行观察和比较。所有评估均在第一次静脉输注 HUC-MSCs 后 1 周、1、2、3 和 6 个月进行。
在 MSCs 组中，从第一次治疗后开始，SF-36 的 PCS 显著改善，并在整个随访期间持续，与安慰剂组相比变化更大（p=0.042）。与安慰剂组相比，2 个月时 MSCs 组的 EQ-VAS 评分显著改善（p=0.023），并持续至 6 个月的随访结束（p=0.002）。计时起立行走（TUG）身体表现测试显示出显著的组间差异，并在 6 个月内持续增强（p<0.05）。MSC 移植改善了 4 米步行测试（4MWT）的功能，与安慰剂组相比，6 个月时的下降幅度为 2.05 秒（p=0.21）。握力测量显示出组间差异，MSC 组表现更好，特别是在 6 个月时（p=0.002）。炎性细胞因子（TNF-α、IL-17）在 6 个月时 MSC 组较安慰剂组下降（p=0.034 和 0.033）。两组不良事件发生率无差异。
静脉输注 HUC-MSCs 是治疗衰老脆弱的一种安全有效的治疗方法。观察到改善生活质量、身体表现和减少慢性炎症的积极结果表明，HUC-MSC 治疗可能是治疗衰老脆弱的一种有前途的潜在治疗选择。
Clinicaltrial.gov；NCT04314011；https://clinicaltrials.gov/ct2/show/NCT04314011。
