
上海和广州的科学家及医生开展的一项随机I期临床试验,在利用从口腔牙龈组织提取的干细胞治疗1型糖尿病方面取得了令人鼓舞的结果。
A randomised phase 1 clinical trial conducted by scientists and doctors from Shanghai and Guangzhou has achieved encouraging results in the treatment of Type 1 diabetes using stem cells extracted from the mouth’s gum tissue.
研究人员表示,接受治疗的受试者中,超过一半表现出不同程度的改善,其中一名受试者能够完全停用外源胰岛素治疗。
More than half of those who received the treatment showed varying degrees of improvement, while one subject was able to discontinue exogenous insulin therapy completely, the researchers said.
该研究测试了一种基于牙龈间充质干细胞(GMSC)的疗法,结果于9月30日发表在医学期刊《信号转导与靶向治疗》上。
Results of the study, which tested a therapy based on gingival mesenchymal stem cells (GMSC), appeared on September 30 in the medical journal Signal Transduction and Targeted Therapy.
1型糖尿病患者胰岛素分泌不足,需要注射胰岛素维持生命。这种糖尿病无法预防,目前也无法治愈。
People with Type 1 diabetes do not produce enough insulin and need to take it to survive. This form of diabetes is not preventable and there is no cure.
患者每天需要多次通过扎手指检测血糖,并在每餐后注射胰岛素。平均而言,他们每天需注射胰岛素四到五次。
Those with the condition need to test their blood sugar – by pricking their fingers – multiple times each day and need an insulin injection after every meal. On average, they can inject insulin four to five times daily.
通讯作者郑松国写道:“这项研究为GMSC治疗1型糖尿病(T1DM)提供了严谨的临床证据,并为开发针对T1DM的免疫靶向疗法提供了一个充满希望的新方向。”
“This study provided rigorous clinical evidence regarding GMSC therapy for Type 1 diabetes mellitus (T1DM) and offered a promising new direction for the development of immune-targeted therapies for T1DM,” corresponding author Song Guo Zheng wrote.
郑松国是一位杰出的免疫学家,现任职于上海交通大学。他是备受争议的“中国行动计划”针对的最高调科学家之一。该计划于美国前总统唐纳德·特朗普首个任期内启动,旨在打击中国科学家涉嫌间谍活动。
Zheng, an eminent immunologist now at Shanghai Jiao Tong University, was one of the highest-profile targets of the controversial China Initiative that was launched in US President Donald Trump’s first term to counter alleged espionage by Chinese scientists.
这位俄亥俄州立大学医学院风湿病学与免疫学前教授,于2020年至2023年在美国入狱,并被勒令偿还数百万美元科研经费,原因是未披露其与中国的关联。
The former professor of rheumatology and immunology at Ohio State University’s College of Medicine was imprisoned in the US from 2020 to 2023 and ordered to repay millions of dollars in research funds for failing to disclose his China ties.
2021年5月,郑某因向美国联邦政府提供虚假陈述的罪名被判处37个月监禁。他从未被认定犯有知识产权盗窃或未经授权转移研究或技术的罪行——这正是“中国行动计划”的公开目标。
In May 2021, Zheng was sentenced to 37 months in prison on charges of making false statements to the US federal government. He was never found guilty of intellectual property theft or unauthorised transfers of research or technology – the stated goals of the China Initiative.
获释后,郑某于2023年7月加入上海交通大学,担任细胞与基因治疗研究所所长,并继续其干细胞研究。
Zheng joined Shanghai Jiao Tong University in July 2023 after his release, serving as dean of the Institute of Cell and Gene Therapy, where he has been continuing his stem cell research.
传统的基于干细胞的1型糖尿病疗法使用胰腺和骨髓干细胞,但这些细胞难以获取,且容易受到人体免疫系统的排斥。
Traditional stem cell-based therapies for Type 1 diabetes use pancreatic and bone marrow stem cells but these are hard to obtain and prone to rejection by the body’s immune system.
郑某将研究重点转向牙龈干细胞,这类细胞可通过拔牙等牙科手术从牙龈组织中更容易地获取,同时保留其分化为分泌胰岛素细胞的能力。
Zheng turned his attention to gingival stem cells, which are easier to obtain from gum tissue – via dental procedures such as tooth extraction – while retaining their ability to differentiate into insulin-secreting cells.
这项临床研究是与中山大学第三附属医院内分泌科主任陈炎明合作开展的,该医院位于中国广州,临床试验采用了郑某此前研究中的细胞方法。
The clinical study was a collaboration with Chen Yanming, director of endocrinology at the Third Affiliated Hospital of Sun Yat-sen University in Guangzhou, southern China, where the trial was conducted using cell methods from Zheng’s previous research.
根据该论文,18名1型糖尿病患者自愿参加临床试验,试验使用的是来自健康患者捐赠的多余牙龈组织所提取的牙龈干细胞,捐赠者年龄在20至30岁之间,并已签署知情同意书。
According to the paper, 18 patients with Type 1 diabetes volunteered to take part in the clinical trial, which used gingival stem cells derived from surplus gum tissue donated with informed consent by healthy patients aged between 20 and 30.
志愿者被随机分组,一半每三周接受一次GMSC注射,其余的则接受安慰剂。他们完成了四次治疗,并接受了48周的随访。
The volunteers were randomised, with half receiving a GMSC injection every three weeks while the remainder were given a placebo. They completed four treatments and were followed for 48 weeks.
四次治疗后,GMSC组相对于基线显示出残余β细胞功能显著增加,55.6%(即九人中的五人)出现了不同程度的改善。
After four treatment sessions, the GMSC group showed a significant increase in residual beta-cell function relative to baseline, with 55.6 per cent – five out of the nine – experiencing varying degrees of improvement.
该组患者的每日胰岛素需求量与基线相比也有所下降。一名患者在首次GMSC治疗后不再需要外源性胰岛素,并在随访期间维持了理想的血糖控制。
The daily insulin requirement for this group also decreased compared with baseline. One patient no longer needed exogenous insulin after the first GMSC treatment and maintained ideal glycaemic control during the follow-up.
在安全性方面,临床研究发现,GMSC治疗没有增加低血糖及其他不良事件的风险,且试验期间未发生任何不良事件。
In terms of safety, the clinical study found that the GMSC treatment did not increase the risk of hypoglycaemia and other adverse events, with none occurring during the trial.
郑总结说:“未来需要进行更大规模、更长周期的队列研究,纳入具有不同残余β细胞功能的受试者,以验证我们的结论并提高结果的普适性。”
“Larger-scale, longer-term cohort studies recruiting participants with diverse residual beta-cell functions are needed in the future to validate our conclusions and improve the generalisability of the results,” Zheng concluded.