Chin Sze-Piaw, Kee Li Ting, Mohd Muzaida Aminah, Then Kong Yong
Cytopeutics Sdn Bhd, Cyberjaya, Selangor, Malaysia.
Cardiology Department, CMH Specialist Hospital, Seremban, Negeri Sembilan, Malaysia.
Diabetes Metab Syndr Obes. 2025 May 19;18:1643-1659. doi: 10.2147/DMSO.S507801. eCollection 2025.
Type 2 diabetes mellitus (T2DM) is characterized by insulin resistance, leading to elevated blood glucose levels. Cellular therapies offer promise for improving hyperglycemia in T2DM. This retrospective study aimed to assess the clinical effectiveness of intravenous allogeneic umbilical cord-derived mesenchymal stem cells (UC-MSCs) infusion in T2DM patients through various clinical evaluations, focusing on systemic inflammation, metabolic dysfunction, and insulin resistance.
The data from a total of 218 T2DM patients who attended for follow-up after 6 months, and 83 patients after 12 months after receiving 50-100×10⁶ allogeneic UC-MSCs were analyzed. Blood and urine samples were collected at baseline and follow-up. Key evaluations included changes in anthropometry, diabetes indices, lipids, liver, renal, hormonal, and inflammatory markers.
All patients demonstrated satisfactory outcomes, without adverse effects. Significant reductions in HbA1c levels were observed at 6-months (p<0.001) and 12-months (p=0.016). Insulin (p=0.048) and HOMA-IR (p=0.007) levels significantly reduced within 6-months, with same trend at 12-months. ALT and GGT levels significantly decreased (p<0.05), indicating a reduction in liver inflammation. hs-CRP level among patients with higher inflammation were also reduced at 6-months (p=0.073) and significantly at 12-months (p=0.016). Testosterone (p=0.050) and estradiol (p=0.043) levels increased in males and females, respectively, during 12-month follow-up. Additionally, estimated glomerular filtration rate (eGFR) and creatinine levels improved in stage 2 chronic kidney disease (CKD) at 6- and 12-month (p<0.05), indicating recovered renal function for those in early stage of CKD.
Allogeneic UC-MSCs infusion is safe for patients with T2DM and is associated with overall health outcomes, with sustained benefits up to 12 months. Notably, the treatment significantly improved metabolic indices including glycemic control, liver and renal profile and systemic subclinical inflammation. These findings provide a basis for further exploration of UC-MSCs in managing T2DM in proper randomized control trial, by addressing both metabolic dysregulation and inflammation.
2型糖尿病（T2DM）的特征是胰岛素抵抗，导致血糖水平升高。细胞疗法有望改善T2DM患者的高血糖状况。这项回顾性研究旨在通过各种临床评估，重点关注全身炎症、代谢功能障碍和胰岛素抵抗，评估静脉输注异体脐带间充质干细胞（UC-MSCs）对T2DM患者的临床疗效。
分析了总共218例T2DM患者的数据，这些患者在接受50-100×10⁶异体UC-MSCs后6个月进行随访，83例患者在12个月后进行随访。在基线和随访时采集血液和尿液样本。主要评估指标包括人体测量学、糖尿病指标、血脂、肝脏、肾脏、激素和炎症标志物的变化。
所有患者均取得了满意的结果，且无不良反应。在6个月时（p<0.001）和12个月时（p=0.016）观察到糖化血红蛋白（HbA1c）水平显著降低。胰岛素（p=0.048）和胰岛素抵抗指数（HOMA-IR）（p=0.007）水平在6个月内显著降低，在12个月时呈相同趋势。谷丙转氨酶（ALT）和谷氨酰转肽酶（GGT）水平显著下降（p<0.05），表明肝脏炎症减轻。炎症较高患者的超敏C反应蛋白（hs-CRP）水平在6个月时也有所降低（p=0.073），在12个月时显著降低（p=0.016）。在12个月的随访期间，男性的睾酮（p=0.050）水平和女性的雌二醇（p=0.043）水平分别升高。此外, 在6个月和12个月时，2期慢性肾脏病（CKD）患者的估算肾小球滤过率（eGFR）和肌酐水平有所改善（p<0.05），表明CKD早期患者的肾功能得到恢复。
异体UC-MSCs输注对T2DM患者是安全的，并且与整体健康结果相关，可持续获益长达12个月。值得注意的是，该治疗显著改善了代谢指标，包括血糖控制、肝脏和肾脏状况以及全身亚临床炎症。这些发现为在适当的随机对照试验中进一步探索UC-MSCs治疗T2DM奠定了基础，该试验同时解决了代谢失调和炎症问题。
