The treatment of diabetes has entered the era of cell therapy. At the end of June, the FDA approved the first cell therapy for type 1 diabetes patients, Lantidra, for the treatment of type 1 diabetes patients who have repeated severe hypoglycemia and cannot reach the target glycosylated hemoglobin after intensive diabetes management and education. (The world's first! FDA approved cell therapy for diabetes. How far is it from ending the era of insulin injections?)
Recently, in my country, based on the registration of stem cell clinical research by the National Health Commission, Tianjin First Central Hospital and Peking University Stem Cell Center worked together to successfully complete the world's first pancreatic islet-like cell transplantation surgery differentiated from chemically reprogrammed induced pluripotent stem cells (CiPSC) in type 1 diabetes subjects.
This is a major breakthrough in my country's stem cell therapy for diabetes.
Mesenchymal stem cells: the most commonly used cell type in diabetes treatment research <br /> In recent years, stem cell therapy has provided a new treatment strategy for diabetes. Various types of stem cells have been widely used in clinical treatment research for diabetes, among which mesenchymal stem cells are the most commonly used. China has also published several research conclusions in the field of mesenchymal stem cell treatment for diabetes.
Mesenchymal stem cells (MSCs) are a type of multipotent stem cells with the potential for self-replication and multidirectional differentiation. They can be derived from a variety of tissues, such as bone marrow, fat, placenta, and umbilical cord, and have the potential to differentiate into multiple cell types, including bone, cartilage, fat, muscle, liver, heart, pancreas, endothelium, lung, and nerve[2].
By secreting a variety of cytokines and growth factors, such as vascular endothelial growth factor (VEGF), hepatocyte growth factor (HGF), fibroblast growth factor (bFGF), transforming growth factor-β (TGF-β) and insulin-like growth factor (IGF-1), it plays an anti-inflammatory, immunomodulatory, angiogenesis-promoting and cell regeneration and repair role.
my country's latest clinical evidence: Mesenchymal stem cells are safe and effective in treating both type 2 and type 1 diabetes
In the past two years, Chinese scholars have published a number of clinical research results related to the treatment of diabetes with mesenchymal stem cells. The latest clinical trial results show that mesenchymal stem cell transplantation is safe and effective in treating type 2 diabetes and type 1 diabetes [2-4].
Achievement 1: Mesenchymal stem cells have been shown to be safe and effective in treating type 2 diabetes
In May 2022, Professor Mu Yiming's team from the Department of Endocrinology at the First Medical Center of the Chinese People's Liberation Army (formerly the 301 Hospital) published the latest "Phase II Clinical Trial of the Efficacy and Safety of Umbilical Cord Mesenchymal Stem Cells in the Treatment of Type 2 Diabetes in Chinese Adults" in the journal Stem Cell Research & Therapy [2]. The results of the study showed that mesenchymal stem cell therapy may be a potential treatment for type 2 diabetes (T2DM) in adults.
91 patients with type 2 diabetes participated in this single-center, double-blind, randomized controlled phase II clinical trial and were randomly divided into a mesenchymal stem cell therapy (UC-MSCs) group (45 cases) and a placebo group (46 cases). The UC-MSCs group was given an intravenous infusion of 1×106/kg for 3 times, each with an interval of 4 weeks. The control group was given a placebo infusion and followed up for 48 weeks.
The results showed that at 48 weeks, ① 20% of patients in the UC-MSCs group had glycosylated hemoglobin (HbA1c) levels < 7.0%, and their daily insulin dosage was reduced by more than half, while it was only 4.55% in the placebo group, with a significant difference between the two groups (p<0.05); ② The HbA1c level in the MSCs group decreased by 1.31%, while that in the placebo group decreased by 0.63%, with a significant difference between the two groups (p=0.0081); ③ There were no serious adverse reactions related to UC-MSCs treatment.
Achievement 2: Mesenchymal stem cell therapy has been shown to protect pancreatic β-cell function in patients with type 1 diabetes
In 2021, Professor Zhu Dalong's team from the Department of Endocrinology at Nanjing Gulou Hospital published "Repeated transplantation of umbilical cord mesenchymal stem cells in type 1 diabetes: an open, non-randomized, parallel-controlled clinical trial" in Stem Cell Research & Therapy [3].
A total of 53 patients (33 adults and 20 adolescents) with type 1 diabetes mellitus (T1DM) participated in the study. Twenty-seven patients were treated in the MSCs group and 26 patients were treated in the control group. The MSCs group received a dose of 1×106/kg, intravenously infused twice, with an interval of 3 months.
After 1 year of follow-up, 11 (11/27, 40.7%) MSCs subjects achieved clinical remission, which was significantly higher than the control group (3/26, 11.5%). Among them, 3 adults treated with MSCs achieved insulin independence and remained insulin-free for 3-12 months, while none of the control group did. MSCs had no serious adverse reactions. The study suggests that for patients with newly diagnosed T1DM, repeated injection of MSCs is safe and may help protect the function of pancreatic β cells.
Outcome 3: Confirmation of the long-term efficacy and safety of mesenchymal stem cells in the treatment of type 2 diabetes
In 2021, a study on the long-term efficacy and safety of umbilical cord mesenchymal stem cells in the treatment of type 2 diabetes [4] randomly divided 61 patients with T2DM into an MSCs group (31 cases) who were given 1×106/kg intravenous infusion twice, 4 weeks apart; and a control group of 30 cases who were given intravenous infusion of normal saline. After 36 months of follow-up, the blood glucose, HbA1c levels, C-peptide, pancreatic β-cell function and the incidence of diabetic complications in the MSCs group were significantly improved.
The authors believe that MSCs infusion can improve the function of pancreatic β cells and reduce the incidence of diabetic complications, and MSCs may be an effective option for the treatment of T2DM patients.
in conclusion
The preliminary clinical results of mesenchymal stem cells in the treatment of diabetes showed that intravenous infusion of MSCs was safe and no serious adverse reactions were observed. MSCs can reduce the HbA1c level of diabetic patients and reduce the daily insulin dosage of patients; some diabetic patients have achieved insulin independence and do not use insulin for 3-12 months; long-term follow-up suggests that MSCs may have a protective effect on pancreatic β cells in patients with T2DM, and mesenchymal stem cells may be an effective choice for the treatment of T2DM patients.
Outlook: Stem cells help reverse the natural course of diabetes
In December 2021, the International Diabetes Federation (IDF) released the 10th edition of the Global Diabetes Atlas [1]. Data show that in 2021, there were 537 million (10.5%) adults aged 20-79 years worldwide with diabetes, or 1 in 10 people. It is estimated that the total number of people with diabetes worldwide will increase to 643 million (11.3%) by 2030 and to 783 million (12.2%) by 2045. More than 1.2 million children and adolescents have type 1 diabetes, more than half (54%) of whom are under the age of 15. In addition, an estimated 240 million people with diabetes are undiagnosed worldwide. In 2021, diabetes caused 6.7 million deaths, or 1 death every 5 seconds. Diabetes is a major disease that poses a serious threat to human health.
In the past 100 years, the development and application of insulin drugs have prolonged the lives of diabetic patients. In the future, stem cells, as an emerging disease treatment method, also show great potential in the treatment of diabetes. As Professor Mu Yiming of the General Hospital of the Chinese People's Liberation Army once said: "Stem cell therapy, as a biotechnology, is the only treatment method among all current glucose-lowering programs that can target the core mechanism of diabetes and reverse the natural course of diabetes."
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