Cellular therapies offer novel opportunities for the treatment of T2DM to improve the function of islet -cells. Fat tissue, aging, and cellular senescence. Therefore, the ability to determine the dose, in vivo distribution, and extended viability of MSCs in patients is crucial in developing MSC-based therapies and elucidating the in vivo therapeutic mechanism of administered MSCs for T2DM treatment [81]. It is notorious that the pathogenesis of obesity-related insulin resistance includes chronic low-grade inflammation and activation of the immune system [21, 70]. The exclusion criteria were: positivity for glutamic acid decarboxylase autoantibody; treatment with thiazolidinediones within 3 mo; history of severe drug allergy; neurological deficiency induced by severe brain injury; severe respiratory disease; severe cardiovascular disease (systolic blood pressure 180 mmHg and/or diastolic blood pressure 110 mmHg or refractory hypertension); severe hepatic dysfunction or uremia; other complications of uncontrollable diabetes, such as stage V and VI diabetic retinopathy and sustained hyperglycemia or catastrophic fluctuations; endocrine and metabolic disease other than diabetes; severe hematologic disease; any acute or chronic infection; any malignancies; human immunodeficiency virus infection; severe psychiatric disease; pregnancy, planned pregnancy, or lactation; taking drugs that affect glucose metabolism within 1 mo, such as glucocorticoid, thiazide diuretic, oral contraceptive, and tricyclic antidepressant; alcohol and drug abuse; participants of any other clinical trials within 3 mo; and, any other disease or status that may influence the patients safety or adherence according to the investigators assessment. Why Does Exercise Sometimes Raise Blood Glucose (Blood Sugar)? Stem cell replacement therapies overcome the barrier of finite availability, but they still face immune rejection. MSCs are a population of multipotent stem cells from the mesoderm. Besides, the expression of enzymes associated with hepatic glycolysis, including glucokinase (GCK), liver pyruvate kinase (L-PK), and 6-phosphofructo-1-kinase (PFK), was greatly elevated. Interestingly, several publications that involved human-derived MSCs revealed that xenogeneic cells conferred suboptimal therapeutic effects in T2DM animal models and did not lead to severe graft rejection [17, 1921]. Without insulin, no cell in the body can use or store glucose normally. Optimization of differentiation protocols of dental tissues stem cells to pancreatic -cells. According to previous studies, intravenous infusion of MSCs will lead to a reduced blood flow velocity in the lung capillaries, which resulted in the formation of local thrombus in the blood vessels [94]. However, further in-depth clarifications regarding the mechanisms of action of MSCs in treating T2DM are still a requisite. Please enable it to take advantage of the complete set of features! and transmitted securely. Si Y., Zhao Y., Hao H., et al. Long-term cultured mesenchymal stem cells frequently develop genomic mutations but do not undergo malignant transformation. Xie M., Hao H. J., Cheng Y., et al. In: Lanza RP, Chick WL, editors. Recently, cell-based therapies have emerged as the next-generation medicine to address intricate physiopathologies of T2DM [810]. However, these injection routes are rarely used in clinical trials, denoting that the long-term distribution of MSCs after intravenous injection should be further compared with the above administration routes in diabetic mice and patients [84]. Insulin resistance occurs when cells in the muscle, adipose tissue, and liver insensitively respond to the action of insulin, thus engendering numerous pathogeneses that encompass the accumulation of ectopic lipid metabolites, activation of unfolded protein response (UPR) pathways, and activation of innate immune pathways [2]. A number of studies in recent years have attempted to identify the underlying mechanisms of renal repair in order to explore the potential regenerative capacity of the kidneys. related to the use of stem cells and autism. 2017, Approximately 30 pre-clinical animal studies using stem cells to treat DDD (Degenerative Disc Disease) have been published, four FDA approved adipose derived stem cell clinical trials at Sanford Health, clinical trial that has just completed it's recruitment, Platelet Rich Plasma Therapy Reviews 2022. The increasing incidence of kidney diseases raises considerable concerns regarding human health worldwide. Disclaimer, National Library of Medicine Yeast infections in women. Leibacher J., Dauber K., Ehser S., et al. also showed that Mitsugumin 53 (MG53), an E3 ligase that promotes the ubiquitinoylation of IRS-1 in skeletal muscles, was inhibited by MSCs (Figure 2) [67]. Moreover, insulin resistance in MAFLD and subsequent hepatic diseases is associated with the overproduction of inflammatory mediators and their downstream signaling molecules, with evidence suggesting that NOD-like receptor protein 3 (NLRP3) inflammasomes play an important role in obesity-induced insulin resistance [21]. Diabetes is the seventh leading cause of death . In particular, iPSCs based on cell reprogramming technology have provided unprecedented opportunities to expedite the development of human cell therapies, without involving the ethical issues of ESCs. Assessment of the effectiveness of human umbilical cord blood-mesenchymal stem cell treatment. Chandravanshi and Bhonde further proved the antiapoptotic effect of MSCs by downregulating reactive oxygen species (ROS), nitric oxide, superoxide ions, caspase 3, caspase 8, and p53 and upregulating Bcl2 under hypoxia circumstances [55]. This is the first clinical trial of hUC-MSC infusion for T2DM treatment approved by the China Medical Biotech Association. Despite improvements in the immunosuppressive regimen, the number of required islets remains high, with two or more donors per patient often needed. Karnieli et al. The Accelerating Medicines Partnership (AMP) is a bold new venture between the NIH, non-profit organizations and biopharmaceutical companies to transform the current model for developing new diagnostics and treatments. Finally, critical challenges toward the clinical translation of MSC therapy for T2DM are discussed through the viewpoint of cellular pharmacokinetics (PK) and safety considerations. Lambert M. ADA releases revisions to recommendations for standards of medical care in diabetes. While the MSCs have been documented as having therapeutic efficacy for inflammation-related diseases, the concerns of possible tumorigenic effects are undeniable; although some studies have shown that MSCs do not undergo malignant transformation[30,31]. PMC It also improved islet -cell function. Li M., al-Jamal K. T., Kostarelos K., Reineke J. Physiologically based pharmacokinetic modeling of nanoparticles. This site needs JavaScript to work properly. T2DM is regarded as a chronic, progressive disease that arises from an impairment in the insulin-sensing mechanisms and culminates in insulin resistance (IR). Phase 3 Trial of Human Islet-after-Kidney Transplantation in Type 1 Diabetes. Learn more Nonetheless, these efforts should be performed in concert with antidiabetic drugs for consolidated maintenance of normoglycemia. 2022. In a relatively small T2DM patient study (n = 18), Kong et al[13] showed responsiveness to treatment of intravenous transfusion of UC-MSCs three times with 2-wk intervals, administered over a 6-mo period. Kircher M. F., Gambhir S. S., Grimm J. Noninvasive cell-tracking methods. It is distributed in accordance with the Creative Commons Attribution NonCommercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. Generally, a longer time is needed to induce -cell dysfunction than insulin resistance and hyperlipidemia, while 30 weeks were taken to induce nonalcoholic steatohepatitis (NASH) syndrome in small animals [18]. Here, we compare the diverse human stem cell approaches and outcomes of recently completed and ongoing clinical trials, and discuss innovative strategies developed to overcome the most significant challenges remaining for transplanting stem cell-derived cells. Xu J., Lu Y., Ding F., Zhan X., Zhu M., Wang Z. Neither the cause of T1D nor the means to prevent it are currently known. demonstrated that mitochondria of MSCs could be transferred to -cells under hypoxia conditions for replenishment. Go to. Stem cell-derived insulin-producing cells can theoretically be generated in endless quantities, potentially overcoming the constraints in both supply and viability. BMC Mol Cell Biol. Once administered intravenously, most of the MSCs were rapidly transferred to the blood vessels of each organ through systemic blood flow. Shrestha M., Nguyen T. T., Park J., Choi J. U., Yook S., Jeong J. H. Immunomodulation effect of mesenchymal stem cells in islet transplantation. This means the patient no longer requires exogenous (external) insulin doses and is producing enough endogenous (internal) insulin to maintain normal blood sugar . Human umbilical cord-derived mesenchymal stem cells ameliorate insulin resistance by suppressing NLRP3 inflammasome-mediated inflammation in type 2 diabetes rats. -, Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, et al. Mesenchymal stem cells ameliorate. Combinatorial human progenitor cell transplantation optimizes islet regeneration through secretion of paracrine factors. Nevertheless, the present models are still unable to represent the long-term in vivo kinetics of MSCs and their secretomes adequately. The journey of islet cell transplantation and future development. The patients islet -cell function was significantly improved, and the dosage of hypoglycemic agents was reduced in all patients without serious adverse events. By Andrew Briskin. Therefore, insulin resistance has become the most prominent predictor of T2DM progression, as well as a potential therapeutic target once hyperglycemia is present [4]. A clinical study that was aimed at improving the erectile function of men with diabetes by the injection of collagen hydrogel and hUC-MSC mixture into the cavernous body was recruiting in 2015. N Engl J Med (2000) 343(4):2308. Zhang Y., Cai W., Huang Q., et al. aP < 0.05. Meanwhile, although researchers reach a consensus on the immunosuppressive effect of MSCs [32], the mechanism that describes how MSCs can affect systemic inflammation has not been thoroughly clarified. In the present study, we observed no significant alterations in tumor-associated antigens (alpha-fetoprotein, carcinoembryonic antigen, carbohydrate antigen 199) within the follow-up period. The MSCs show their antiapoptotic effect by downregulating ROS, caspase 3, caspase 8, and p53 and upregulating Bcl2. . Following intrasplenic transplantation, AD-MSCsLuc+ were mainly observed in the liver and pancreas until day 8 after intrasplenic and intrapancreatic injection, respectively. Both, There are more than 2,000 scientific publications published related to "stem cell" and "spinal cord injury" on the. Bloor A. J. C., Patel A., Griffin J. E., et al. The remaining author declares that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest. However, the duration of obesity and T2DM induction varies between different studies, thus causing different pathological stages of T2DM. One patient (2.08%) had asymptomatic nocturnal hypoglycemia after infusion on day 28 3. Considering that mitochondria play a central role in energy metabolism, their intercellular transfer may partially explain the therapeutic mechanism of MSCs in improving -cell regeneration. This work is financially supported by the National Key Research and Development Program of China (2017YFA0104901), the Beijing Municipal Science and Technology Commission (Z181100001818005), and the China Postdoctoral Science Foundation (043220012). IL-6 inhibitors have been studied mainly for their potential to calm down the 'cytokine storm' associated with ARDS (acute respiratory distress syndrome), a severe COVID-19 lung complication. Brain uptake pharmacokinetics of incretin receptor agonists showing promise as Alzheimers and Parkinsons disease therapeutics. Brooks A., Futrega K., Liang X., et al. discovered that despite the elevated insulin production of streptozotocin- (STZ-) induced mice at 42 days after the intravenous injection of hBM-MSCs, the majority of the transplanted cells migrated to ductal and islet structures, and only a minority of transplanted cells are labeled with insulin [51]. Stem cell therapy for insulin-dependent diabetes: Are we still on the road? Several other comparative studies have demonstrated good evidence in the treatment of osteoarthritis. Within recent years, stem cell research has become a very important part of the scientific understanding of type 1 diabetes. Aroda V. REWIND to fast forward: time to revisit stroke prevention in type 2 diabetes? Upon study enrollment, all participants were assessed for diabetes, complications, diet, and exercise in the Diabetic Out-Patient Clinic over a period of 16 wk prior to the initiation of intervention. Patients were enrolled and received 1 106 cells/kg per week for 3 wk of intravenous hUC-MSC infusion. There was no significant alteration in carcinoembryonic antigen (Figure (Figure3)3) or pancreatic autoantibody in the patients. You can review the status and details of these trials on, Many people are very interested in the possibility of stem cells to treat diabetes. However, certain pathologies of T2DM, such as -cell exhaustion, hepatic dysfunction, insulin resistance, and systemic inflammation, remain refractory with the employment of conventional medications. In conformity with the American Diabetes Association (ADA), the regular treatment of T2DM is based on lifestyle interventions, including a healthy diet, weight loss, and regular practice of physical activity [5]. Upon MSC administration, PPAR- was upregulated while PPAR- was downregulated. In type 2 diabetes, cells in the body become resistant to insulin. Xiu-Qun Han, Department of Research & Development, Zhejiang MaiDa Gene Tech Co. Ltd, Zhoushan 316000, Zhejiang Province, China. MSCs also facilitate the inhibition of MG53, which is an E3 ligase that promotes the ubiquitinoylation of IRS-1 in skeletal muscles. Roles of the co-culture of human umbilical cord Wharton's jelly-derived mesenchymal stem cells with rat pancreatic cells in the treatment of rats with diabetes mellitus. Hu et al[22] showed that hUC-MSC treatment decreased the FCP and improved the HOMA-IR. A clinical trial is a way to carefully test a new drug or device in patients before it is approved by the FDA to be used in the general public. Keywords: clinical trial (CT); encapsulation; islets; stem cells; transplantation; type 1 diabetes (T1D); type 2 diabetes (T2D). Zhang Y., Gao S., Liang K., et al. Sun Y., Shi H., Yin S., et al. Salameh T. S., Rhea E. M., Talbot K., Banks W. A. In a Chinese clinical trial, 12 T2DM patients who failed to reinstate normal glycemic control after liraglutide treatment were treated with 1 106 cells/kg of hUC-MSCs via pancreatic artery infusion on the first day, with another 1 106 cells/kg of cells infused through the peripheral vein on days 8, 15, and 22. Type 1 diabetes occurs when the immune system, a complex network of cells and proteins that defend the body against infection and keep you healthy, attacks the beta cells in the islets of the pancreas that produce insulin, called islet cells. You can search the database to look for more details of the clinical trials including the countries and centres that are conducting them. TrialNet Sanz-Nogus C., O'Brien T. Current good manufacturing practice considerations for mesenchymal stromal cells as therapeutic agents. ViaCyte has the first and only islet cell replacement therapies derived from stem cells in clinical trials for diabetes. Yan-Jing Liu, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. Instead, to address limitations related to supply, human embryonic stem cell (hESC)-derived cells are being explored as surrogates for cadaveric islets. Khan M. A., Alanazi F., Ahmed H. A., et al. Li J. In addition to optimizing the MSC sources, animal models, administration routes, and dosages, cell engineering strategies have been scrutinized to improve the therapeutic outcomes of MSCs. On the other hand, although studies have shown that MSCs exhibit immunoregulatory effects, it remains elusive as to what degree the allogeneic cells trigger immune responses in vivo after the administration [103]. Pickup J. C. Inflammation and activated innate immunity in the pathogenesis of type 2 diabetes. You can review the status and details of these trials on. will also be available for a limited time. Rap1 deficiency-provoked paracrine dysfunction impairs immunosuppressive potency of mesenchymal stem cells in allograft rejection of heart transplantation. 2021 Mar 11;12:636824. doi: 10.3389/fendo.2021.636824. Lee M., Jeong S. Y., Ha J., et al. Bone marrow derived stem cell therapy for type 2 diabetes mellitus. To evaluate the effectiveness and safety of human umbilical cord-mesenchymal stem cell (hUC-MSC) infusion in T2DM treatment. Furthermore, combinatorial therapy of intrapancreatically infused autologous stem cells (ASCs) and hyperbaric oxygen therapy (HBO) can improve the metabolic and insulin control of T2DM patients. A., et al. Besides, studies of the pharmacokinetic model have the ability for interspecies scaling, allowing us to predict the in vivo kinetics of therapeutic MSCs in humans through animal data. CONSORT 2010 statement: The authors have read the CONSORT 2010 statement, and the manuscript was prepared and revised according to the CONSORT 2010 statement. Si et al[27] showed that the increased pancreatic islets and islet -cells were not due to cell proliferation but to tissue repair and a decrease in apoptosis and damage in a rat model of T2D. 8600 Rockville Pike The estimated prevalence of diabetes and prediabetes among adults in China is 10.9% and 35.7% respectively[1], of which type 2 diabetes mellitus (T2DM) accounts for more than 90% of cases. The FBG had a sustained decrease during the follow-up visit period, with a reduction of hypoglycemic agents for all patients. MSCs could protect endogenous cells. Moreover, other supporting data on this concept have been reported [91]. Although the therapeutic efficacy of MSC therapies for T2DM has been postulated decades ago, their underlying mechanisms remain elusive. However, only a limited number of articles summarize the versatile therapeutic effects of MSCs among diverse formulation and dosing regimens on T2DM animal models. Therefore, further studies should be carried out to establish the standard guidelines to be implemented in MSC therapy. In conclusion, the above mechanistic investigation provides a theoretical basis for the clinical application of MSCs in the treatment of T2DM along with its associated complications. Indisputably, the functional proteins secreted by genetically modified MSCs may be useful to mitigate NASH and metabolic-associated fatty liver disease (MAFLD) concomitantly, concerning that diabetes is intimately associated with these complications. Gu J, Huang L, Zhang C, Wang Y, Zhang R, Tu Z, Wang H, Zhou X, Xiao Z, Liu Z, Hu X, Ke Z, Wang D, Liu L. Therapeutic evidence of umbilical cord-derived mesenchymal stem cell transplantation for cerebral palsy: a randomized, controlled trial. Zheng-Jie Huang, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. Mesenchymal stem cells are used as immuno-modulators for severe COVID-19 patients and some of the trial projects are launched in combination with other medications such asinterleukin (IL) 6 inhibitors e.g. In brief, classically activated macrophages (M1) could stimulate MSCs to overexpress IL-6 and MCP-1, thus converting M1 into an alternatively activated phenotype (M2) (Figure 2). Treatment: How do we keep up with all these stem cell therapy evidence and research? Beta cell dysfunction and insulin resistance. Accessibility Applications of physiologically based pharmacokinetic (PBPK) modeling and simulation during regulatory review. 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