BMI: Body mass index; FPG: Fasting plasma glucose; P2PG: 2-h postprandial plasma glucose; HbA1c: Glycosylated hemoglobin; FCP: Fasting c-peptide; P2CP: 2-h postprandial c-peptide; HOMA-IR: Homeostasis model assessment of insulin resistance; HOMA-: Homeostasis model assessment of -cell function. The latest study confirmed that exosomal miR-29b-3p can regulate cellular insulin sensitivity via sirtuin- (SIRT-) 1 (Figure 2) [14], which is a class III histone deacetylase deeply involved in apoptosis, genomic stability, and gene expression regulation, indicating that histone modification related to insulin resistance is one of the treatment approaches of MSCs. In addition, Akiyama et al. Ho J. H., Tseng T. C., Ma W. H., et al. MH also serves as SAB member to 1351 Thymmune and Encellin, and is co-Founder, SAB and Board member for 1352 EndoCrine and Minutia. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Su T., Xiao Y., Xiao Y., et al. 2017 Jul;6(7):1631-1643. doi: 10.1002/sctm.17-0005. Recently, cell-based therapies have emerged as the next-generation medicine to address intricate physiopathologies of T2DM [810]. Caplan AI, Dennis JE. Insulin resistance is primarily compensated by elevated insulin secretion, which eventually leads to T2DM due to the exhaustion of pancreatic -cells [3]. Primary MSCs isolated from different donors, tissue sources, cell separation methods, or culture conditions show natural heterogenicity, which causes batch-to-batch variation and diverse differential and therapeutic efficacy [97, 98]. The Exendin-4 secreted by MSC-Ex-4 improved MSC survival under high glucose stress via autocrine activation of the GLP-1R-mediated AMPK signaling pathway, as well as suppressed senescence and apoptosis of pancreatic -cells through endocrine effects. To date, Cymerus MSCs (CYP-001), which are derived from adult iPSCs produced by an optimized GMP-compliant manufacturing process, have been characterized by Cynata Therapeutics and received approval to launch the world's first formal trial for the treatment of acute steroid-resistant GvHD [107, 108]. IDF diabetes atlas ninth. Sood et al. However, with the continuous advancement of gene-editing tools with unprecedented spatiotemporal control, we believe that the genetic manipulation techniques are prompt to have enhanced precision, efficacy, and safety [32, 33]. MSCs can reduce the number of impaired mitochondria and systemic ROS levels to prevent liver metabolic imbalance. The multiplexed ability of MSCs to ameliorate T2DM-associated metabolic syndromes such as hyperglycemia, insulin resistance, and systemic inflammation has heretofore been delineated by numerous animal studies. Initially, the IR is compensated by increased insulin production; however, as the T2DM progresses over time, the general pancreatic dysfunction leads to increasingly lower insulin production. Heparin improves BMSC cell therapy: anticoagulant treatment by heparin improves the safety and therapeutic effect of bone marrow-derived mesenchymal stem cell cytotherapy. 2022 Jul 26;13(1):348. doi: 10.1186/s13287-022-03028-2. Moreover, the clearance of dysfunctional mitochondria, alleviation of ERS, and diminishment of ROS may ameliorate insulin resistance [69]. [PMC free article] . In this review, we summarize various animal and clinical studies of MSC therapy in treating T2DM. In this model, the cell-related biomarkers released by MSCs, which are capable of influencing bystander cells (e.g., macrophages), can secrete specialized bioactive substances that play a main role in the PD of administered cells [90]. Jiang R., Han Z., Zhuo G., et al. Stem cell therapy for insulin-dependent diabetes: Are we still on the road? Mesenchymal stem cells and immunomodulation: current status and future prospects. The progress of pluripotent stem cell-derived pancreatic -cells regeneration for diabetic therapy. Clinical trials are an important step in our being able to have new treatments for diabetes and other conditions. Chandravanshi B., Bhonde R. R. Shielding engineered islets with mesenchymal stem cells enhance survival under hypoxia. El-Sherbiny M., Eladl M. A., Ranade A. V., Guimei M., Gabr H. Functional beta-cells derived from umbilical cord blood mesenchymal stem cells for curing rats with streptozotocin-induced diabetes mellitus. Quantitative data were analyzed with the two-samples Wilcoxon test. Recent studies proved that symptoms of T2DM patients who are unresponsive to conventional medications could be relieved with mesenchymal stem/stromal cell (MSC) therapy. iPSC-derived MSC therapy induces immune tolerance and supports long-term graft survival in mouse orthotopic tracheal transplants. Yan-Jing Liu, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. Despite improvements in the immunosuppressive regimen, the number of required islets remains high, with two or more donors per patient often needed. did not track the BM-MNCs for a longer time. 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. 2022 Jun 29;14(13):2641. doi: 10.3390/polym14132641. D2d In short, understanding the in vivo kinetics of administered drugs can be challenging, especially for nontraditional drugs such as MSCs. 10.1056/NEJM200007273430401 As of October 2022, there are more than 130 studies that have been launched to investigate the benefits of stem cell therapy and diabetes mellitus. 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. During the entire intervention period, the fasting plasma glucose level was significantly reduced [baseline: 9.3400 (8.3575, 11.7725), day 14 3: 6.5200 (5.2200, 8.6900); P < 0.01]. Current treatments for diabetes include diet control, physical exercise, oral antidiabetic agents, and insulin therapy. RISE Mesenchymal stem/stromal cells (MSCs) have demonstrated their therapeutic effects in both animal studies and clinical studies, thus offering adept modalities in treating T2DM. Routine safety assessment was conducted according to the visit schedule, including blood routine examination, hepatic function test, electrocardiogram, chest radiography, and tumor-associated antigen test. Tsai PJ, Wang HS, Lin GJ, Chou SC, Chu TH, Chuan WT, Lu YJ, Weng ZC, Su CH, Hsieh PS, Sytwu HK, Lin CH, Chen TH, Shyu JF. This policy also applies to patient surveys. Thomson JA, Itskovitz-Eldor J, Shapiro SS, Waknitz MA, Swiergiel JJ, Marshall VS, Jones JM. tocilizumab. Brief Summary: To study the effect of type 2 diabetes (T2D) on vascular wall inflammation and hematopoietic stem cell composition in vivo, and whether these changes can be reversed with glucagon like peptide 1 receptor (GLP1R)-agonism. ViaCyte's implantable medical devices are designed to contain our cell replacement therapies and allow for cell survival and function. . that were found for 'stem cell and hair loss' under the U.S. Clinical Trial Registry. To date, eight classes of antidiabetic drugs have been approved by the Food and Drug Administration (FDA), including the first-line drug metformin and newly developed glucagon-like peptide-1 receptor agonists (GLP-1RAs) [6], along with versatile medication protocols such as monotherapy, dual therapy, and multiagent therapy to improve the efficacy of T2DM treatment [7]. The new PMC design is here! In addition, some researchers correlated the islet repairing potential of MSCs to their antiapoptotic effects. According to the summarization of preclinical and clinical results in the aforementioned studies, MSC-based therapy has made tremendous progress in T2DM treatment in both animal studies and clinical trials. It is estimated that over 9% of the population in Ukraine is living with diabetes mellitus, a condition that can cause costly and debilitating complications including heart attacks, strokes, kidney failure, blindness and lower-limb amputations if untreated. After intravenous infusion of hUC-MSCs, the dosage of hypoglycemic agent was reduced in all patients on day 28 3, of whom 12 (75%) had a decrement of 10%-50% and 4 (25%) had a decrement of 50%. Westenfelder C, Gooch A, Hu Z, Ahlstrom J, Zhang P. Stem Cells Transl Med. Nevertheless, these genetically engineered MSCs still exhibited numerous setbacks, which lead to the underwhelming therapeutic effects of MSCs. Xiu-Qun Han, Department of Research & Development, Zhejiang MaiDa Gene Tech Co. Ltd, Zhoushan 316000, Zhejiang Province, China. Briefly, the cells were adherent to plastic, positive for cluster of differentiation (CD) 105, CD73, and CD90, and negative for CD45, CD34, CD14 or CD11b, CD79alpha or CD19, and human leucocyte antigen DR. 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. California Supreme Court Victory Supports Access to Insulin for California Students, Extracurricular Activities and Field Trips, Individuals with Disabilities in Education Act, The ADAs Lawsuit Against New York City Public Schools, Medical and Scientific Sources of Authority, How to Resolve Diabetes School Care Problems, Safe at School COVID-19 (Coronavirus) Resources, Common Issues Involving Diabetes Care Tasks at School/Child Care/Camp, Tips for Managing Diabetes in the Child Care Setting, Section 504 of the Rehabilitation Act of 1973, https://www.facebook.com/AmericanDiabetesAssociation?loc=superfooter, https://twitter.com/AmDiabetesAssn?loc=superfooter, https://www.instagram.com/AmDiabetesAssn/?loc=superfooter, https://www.youtube.com/user/AmericanDiabetesAssn. Researches on extracellular vesicles from urine-derived stem cells (USC-EVs) have shown that they have significant therapeutic effects in a variety of diseases by injection including ED. Ma S., Xie N., Li W., Yuan B., Shi Y., Wang Y. Immunobiology of mesenchymal stem cells. Palmer A. K., Tchkonia T., LeBrasseur N. K., Chini E. N., Xu M., Kirkland J. L. Cellular senescence in type 2 diabetes: a therapeutic opportunity. Volarevic V., Arsenijevic N., Lukic M. L., Stojkovic M. Concise review: mesenchymal stem cell treatment of the complications of diabetes mellitus. have been launched to investigate the potential of stem cell therapy for spinal cord injuries under the U.S. Clinical Trial Registry. For many patients battling deadly diseases, getting access to a clinical trial can be life-saving, but it can also be very challenging. Some of these impediments have become a mutual subject in the field of cell therapy, but some necessitate particular considerations due to the special characteristics of T2DM that are distinct from other diseases. Hong-Li Liu, Department of Endocrinology, Peking University Shenzhen Hospital, Shenzhen 518000, Guangdong Province, China. As of October 2022, there are more than 60 studies that have been launched to investigate the benefits of stem cell therapy and stroke. At least one (Regenexx) is maintaining a, There are more than 290,000 scientific publications published on "stem cell' on the. 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. Although plenty of drugs are currently available for type 2 diabetes mellitus (T2DM), a subset of patients still failed to restore normoglycemia. Since its introduction more than twenty years ago, intraportal allogeneic cadaveric islet transplantation has been shown to be a promising therapy for patients with Type I Diabetes (T1D). Researchers have long sought a cell-based "cure" for type 1 diabetes, and in recent years, this goal has seemed more attainable. If you take pioglitazone (Actos) or a combination drug with pioglitazone in it (Actoplus Met, Duetact), call your . Most significantly, previous studies have indicated that MSCs are capable of exerting certain antidiabetic effects, as supported by the evidence that multiple infusions of MSCs may reverse hyperglycemia instead of single-dose infusion [15, 16]. BM-MNCs were administered to diabetic patients through three different routesperipheral intravenous, superior pancreaticoduodenal artery, and splenic artery injectionwith the in vivo biodistribution of cells tracked and quantified at 30 and 90 minutes after administration. In conclusion, the therapeutic effects of MSCs on T2DM are multifaceted [121] and the possible therapeutic mechanisms have been summarized here. related to the use of stem cells in diabetes mellitus. have been launched to investigate the potential of stem cell therapy for kidney disease under the U.S. Clinical Trial Registry. All authors read and approved the final manuscript. In addition, Milanesi et al. A Peripheral T Cell Lymphoma Clinical Trials Recruiting. The HOMA-IR decreased but not to a level that was statistically significant (Figure (Figure22). Consequently, fragments produced by apoptotic MSCs are phagocytosed by macrophages to produce indoleamine 2,3-dioxygenase, which helps to mediate systemic inflammation inhibition. Epub 2019 Dec 2. Lee C. W., Hsiao W. T., Lee O. K. Mesenchymal stromal cell-based therapies reduce obesity and metabolic syndromes induced by a high-fat diet. Khan M. A., Alanazi F., Ahmed H. A., et al. Still, the fate of MSCs in the lung is controversial as the fluorescence signal gradually disappeared during long-term tracking [93]. Mesenchymal stromal cells improve transplanted islet survival and islet function in a syngeneic mouse model. Baseline clinical characteristics of the patients. The study by Sood et al. Xie Z., Hao H., Tong C., et al. Zhang L., Zhang L., Li L., Hlscher C. Neuroprotective effects of the novel GLP-1 long acting analogue semaglutide in the MPTP Parkinsons disease mouse model. Sun Y., Shi H., Yin S., et al. Liu et al[12] showed that injection of UC-MSCs with a 5-d interval decreased glycosylated hemoglobin A1c (HbA1c) levels and required insulin dose in patients with T2DM. Centers for Medicare and Medicaid Service: Clinical Trials Coverage (CMS), 2451 Crystal Drive,Suite 900 This trial is testing whether semaglutide can help control blood sugar and weight in people with type 2 diabetes who are also overweight, when taken with metformin. R01 DK105831/DK/NIDDK NIH HHS/United States, Barker M. Pancreatic islet transplantation. Long-term cultured mesenchymal stem cells frequently develop genomic mutations but do not undergo malignant transformation. Brooks A., Futrega K., Liang X., et al. Besides, MSCs are capable of enhancing the formation of autophagosomes by clearing impaired mitochondria and increasing the number of insulin granules (Figure 1) [22]. Therefore, the production of MSCs complying with the current good manufacturing practice (cGMP) standards becomes a prerequisite to ensure the standardization and reproducibility, as well as the quality and safety of MSCs for clinical use [99]. . Evidence shows that the infusion of MSCs will activate protein kinase B (AKT) and AMP-activated protein kinase (AMPK) signaling pathways, which play indispensable roles in cell metabolism (Figure 1) [24, 25]. Department of Biomedical Engineering, School of Medicine, Tsinghua-Peking Center for Life Sciences, Tsinghua University, Beijing 100084, China. GRADE White blood cells, also known as lymphocytes, give rise to cancer cells, which then pervade the body. 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. MSCs promote insulin production by facilitating the regeneration of endogenous pancreatic islet -cells, and several hypotheses about their fundamental mechanisms have been reported. History of Changes for Study: NCT05597202 Does the Hematopoietic Stem Cell Govern Residual Inflammatory Cardiovascular Risk in Type 2 Diabetes (DOTAFLAME) Latest version (submitted October 26, 2022) on ClinicalTrials.gov A study version is represented by a row in the table. 2022 Jul 26;14(7):503-512. doi: 10.4252/wjsc.v14.i7.503. -, Shapiro AM, Lakey JR, Ryan EA, Korbutt GS, Toth E, Warnock GL, et al. However, only a limited number of articles summarize the versatile therapeutic effects of MSCs among diverse formulation and dosing regimens on T2DM animal models. U.K. Despite its positive outcome, the impact of islet transplantation has been limited due to a number of confounding issues, including the limited availability of cadaveric islets, the typically lifelong dependence of immunosuppressive drugs, and the lack of coverage of transplant costs by health insurance companies in some countries. Undifferentiated Wharton's Jelly Mesenchymal Stem Cell Transplantation Induces Insulin-Producing Cell Differentiation and Suppression of T-Cell-Mediated Autoimmunity in Nonobese Diabetic Mice. Besides, autologous cells are hard to be developed as off-the-shelf products due to their longer processing duration after being extracted from patients. MSCs can improve the systemic inflammatory state through their immunosuppressive functions, reduce the apoptosis of islet -cells to augment insulin secretion, and improve the metabolic state of the liver. Thus, hUC-MSC treatment could be a novel therapy for T2DM. Si Y, Zhao Y, Hao H, Liu J, Guo Y, Mu Y, Shen J, Cheng Y, Fu X, Han W. Infusion of mesenchymal stem cells ameliorates hyperglycemia in type 2 diabetic rats: identification of a novel role in improving insulin sensitivity. Xu J., Lu Y., Ding F., Zhan X., Zhu M., Wang Z. Hao H., Liu J., Shen J., et al. (b) Possible mechanisms of action for MSCs to influence hepatic metabolic homeostasis. Stem cells in the research of type 1 diabetes. Long term effect and safety of Whartons jelly-derived mesenchymal stem cells on type 2 diabetes. However, it is indefinite how well the findings in animals can be quantitatively transferred to humans. Scuteri A., Monfrini M. Mesenchymal stem cells as new therapeutic approach for diabetes and pancreatic disorders. Federal government websites often end in .gov or .mil. On Monday, Vertex Pharmaceuticals announced that the first Type 1 diabetes (T1D) patient to be dosed in the Phase I/II clinical trial of its investigational stem cell-derived therapy, VX-880, saw their need for insulin disappear almost entirely, marking a great stride in finding a cure for the lifelong disease. Besides, mitochondria of MSCs could be transferred to -cells under hypoxia conditions to enhance the insulin secretion rate. during systemic injection [95], while MSCs were pretreated with hypertonic solution by Leibacher et al. Background. 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. Therefore, although previous clinical trials showed that intravenously injected MSCs can cause pulmonary microembolism, no serious adverse reactions have been indicated so far [40]. Insulin resistance, which is a distinctive hallmark of T2DM, describes the failure of cells to respond to insulin during disease progression. The goal of the Vitamin D and type 2 diabetes (D2d) study is to determine whether vitamin D supplementation is safe and effective in delaying the onset of type 2 diabetes in people at risk for the disease, and to gain a better understanding of how vitamin D affects glucosemetabolism. Type 2 diabetes (diabetes mellitus) is a chronic disease that tremendously impacts patients and society. We conducted the present trial to treat T2DM with hUC-MSC infusion and evaluated the effectiveness and safety of hUC-MSC therapy. Moreover, MSCs can downregulate the systemic inflammatory cytokines to impair insulin receptor action and respective downstream signaling pathways by preventing the formation of NLRP3 in the adipose tissue and liver [35]. Mesenchymal stem cells protect NOD mice from diabetes by inducing regulatory T cells. MSC transplantation in streptozotocin-treated mice promoted the proliferation of endogenous islet cells and increased the amount of islet -cells and insulin secretion[26]. -, Bretzel RG, Hering BJ, Schultz AO, Geier C, Federlin K. International islet transplant registry report. (b) Possible mechanisms of action for MSCs to regulate systemic inflammation. . Here, we have listed and compiled all significant scientific publications related to stem cell therapy. 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]. Get an overview of pipeline landscape @ Type 2 Diabetes Clinical Trials Analysis . The glutathione (GSH)/oxidized glutathione (GSSG) ratio was reduced, and the amount of superoxide dismutase, which is inversely proportional to systemic ROS levels, was increased after MSC treatment (Figure 1) [64, 65], postulating that the therapeutic effect of MSCs is highly associated with metabolic homeostasis. Once administered intravenously, most of the MSCs were rapidly transferred to the blood vessels of each organ through systemic blood flow. 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. FDA is responsible for protecting the public health by assuring the safety, efficacy and security of human and veterinary drugs, biological products, medical devices, our nation's food supply, cosmetics, and products that emit radiation. Bethesda, MD 20894, Web Policies Domouky AM, Hegab AS, Al-Shahat A, Raafat N. Mesenchymal stem cells and differentiated insulin producing cells are new horizons for pancreatic regeneration in type I diabetes mellitus. sharing sensitive information, make sure youre on a federal Keywords: clinical trial (CT); encapsulation; islets; stem cells; transplantation; type 1 diabetes (T1D); type 2 diabetes (T2D). On day 84 3, the dosage was reduced in all patients, of whom 6 (50%) had a decrement of more than 50% and 1 (6.25%) discontinued the hypoglycemic agents (Figure (Figure22). 50 percent of a person's susceptibility to type 2 diabetes. Flow chart for the study procedure. The entrapped MSCs were either released back into the blood circulation or eliminated after depletion (Figure 3). As of October 2022, there are more than 1,000 studies that have been launched to investigate the benefits of stem cell therapy and leukemia. Overview of 6 years' therapy of type II diabetes: a progressive disease. Briefly, MSC activation is subjected to the stimulation of a multitude of inflammatory cytokines, including TNF- and interferon- (IFN-) , which in turn shift to an immunosuppressive phenotype by inducing the secretion of soluble factors that mediated immunomodulatory activities, such as prostaglandin E2 (PGE2), hepatocyte growth factor (HGF), indoleamine-pyrrole 2,3-dioxygenase (IDO), and IL-10 [73, 74]. GRADE is a comparative effectiveness study looking at what medications work best at loweringblood sugar levels in patients who are newly diagnosed with diabetes. While the discovery of insulin 100 years ago transformed type 1 diabetes from a fatal illness to a chronic illness, it is not a cure. FPG: Fasting plasma glucose; P2BG: 2-h postprandial blood glucose; FCP: Fasting C-peptide; P2CP: 2-h postprandial C-peptide; HbA1c: Glycosylated hemoglobin A1c; HOMA-IR: Homeostasis model assessment of insulin resistance; HOMA-: Homeostasis model assessment of -cell function. Samuel V. T., Shulman G. I. Mechanisms for insulin resistance: common threads and missing links. FPG was significantly reduced on day 14 3 without any alteration of hypoglycemic drug dosage, achieving the lowest level during the entire intervention period [baseline: 9.3400 (8.3575, 11.7725), day 14 3: 6.5200 (5.2200, 8.6900); P < 0.01]. This means the patient no longer requires exogenous (external) insulin doses and is producing enough endogenous (internal) insulin to maintain normal blood sugar . Fu Y, Li J, Li M, Xu J, Rong Z, Ren F, Wang Y, Sheng J, Chang Z. Umbilical Cord Mesenchymal Stem Cells Ameliorate Inflammation-Related Tumorigenesis via Modulating Macrophages. Finally, critical challenges toward the clinical translation of MSC therapy for T2DM are discussed through the viewpoint of cellular pharmacokinetics (PK) and safety considerations. As of October 2022, there are more than 130 studies that have been launched to investigate the benefits of stem cell therapy and diabetes mellitus. that were found for 'stem cell and anti-aging' under the U.S. Clinical Trial Registry. . A liver transplant is currently the standard treatment to end-stage liver cirrhosis. aP < 0.05. Corresponding author: Fan Zhang, MD, Doctor, Department of Endocrinology, Peking University Shenzhen Hospital, No. The .gov means its official. Embryonic stem cell lines derived from human blastocysts. Besides, it is well established that MSCs can play their therapeutic roles beyond what is conveyed by the transplanted cells alone, mainly through the secretion of bioactive products, namely, the secretome [89]. Madec A. M., Mallone R., Afonso G., et al. We conducted the present trial to explore the therapeutic effectiveness and mechanism of hUC-MSC infusion for treating T2DM. 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