Stem Cell Therapy For Type 1 Diabetes Mellitus: A Review Of Recent Clinical Trials
CarlosEduardoBarraCouri 1 Email author and Couri and Voltarelli; licensee BioMed Central Ltd.2009 Stem cell therapy is one of the most promising treatments for the near future. It is expected that this kind of therapy can ameliorate or even reverse some diseases. With regard to type 1 diabetes, studies analyzing the therapeutic effects of stem cells in humans began in 2003 in the Hospital das Clnicas of the Faculty of Medicine of Ribeiro Preto - SP USP, Brazil, and since then other centers in different countries started to randomize patients in their clinical trials. Herein we summarize recent data about beta cell regeneration, different ways of immune intervention and what is being employed in type 1 diabetic patients with regard to stem cell repertoire to promote regeneration and/or preservation of beta cell mass. The Diabetes Control and Complications Trial (DCCT) was a 7-year longitudinal study that demonstrated the importance of the intensive insulin therapy when compared to conventional treatment in the development of chronic complications in patients with type 1 diabetes mellitus (T1DM). This study also demonstrated another important issue: there is a reverse relationship between C-peptide levels (endogenous indicator of insulin secretion) chronic complications - that is, the higher the C-peptide levels, the lower the incidence of nephropathy, retinopathy and hypoglycemia. From such data, beta cell preservation has become an additional target in the management of T1DM [ 1 ]. Beta CellSitagliptinDiabetic KetoacidosisIntensive Insulin TherapyBeta Cell Mass Immune interventions used in type 1 diabetes Since the identification of the autoimmune etiology of T1DM in the late 1970s, the use of immunosuppressive agents began to occur. In 1981, Eliot and colleagues [ 2 ] Continue reading >>
Type 1 Diabetes Stem Cell Therapy Trials Progressing
Diabetes Stem Cell Treatment Developing Swiftly A recent article published on the Science Dailys online site comes from findings at the Washington University School of Medicine. It reports that its possible to coax stem cells harvested from diabetic patients to convert into cells that secrete insulin*. This is big news. Diabetes stem cell research is continuing to make strides. It could mean that people suffering from Type 1 diabetes may someday not need insulin shots or pumps.* Stem cell treatment for diabetes signals a likely new way to treat Type 1 diabetic sufferers. *The stem cells come from the patients own bodies. Researchers are successfully producing insulin-secreting cells from these donor stem cells, creating the possibility of a targeted, personally tailored diabetes stem cell treatment for Type 1 diabetes patients.* Among the prestigious schools that are conducting diabetes stem cell research are Washington University School of Medicine in St. Louis and Harvard University. Each has successfully coaxed Type 1 diabetes patients stem cells to become insulin-secreting cells.* Why Diabetes Stem Cell Therapy Is Exciting News Type 1 diabetics are not able to produce their own insulin and must rely on repeated insulin injections in order to manage their blood sugar. Thats why diabetes stem cell research and treatments is causing such a stir in the medical and scientific communities. Should official confirmation come through that Type 1 diabetics may soon be able to produce their own insulin-making cells, the lives of millions of people worldwide will be affected. It has already been established through clinical trials that stem cells that have been converted to insulin makers produced insulin while encountering sugar.* That means the pace is quickening in the deve Continue reading >>
Researchers Study Cure For Type 1 Diabetes In Stem Cell Transplantations
Clinical trial shows promising results from risky procedure, identifies path for personalized therapies DUARTE, Calif. — Some type 1 diabetes (T1D) patients can be cured from the disease, at least for a number of years, with a stem cell transplant – those were the results of a clinical trial monitored by City of Hope’s Bart Roep, Ph.D., the Chan Soon-Shiong Shapiro Distinguished Chair in Diabetes and professor/founding chair, Department of Diabetes Immunology. The results were published recently in the journal, Frontiers in Immunology. “This means we can cure type 1 diabetes, be it with a risky therapy — although one that is also very successful in cancer, and one for which City of Hope is a world-renowned expert, with more than 14,000 patients having received similar treatment for blood cancers,” said Roep, director of The Wanek Family Project for Type 1 Diabetes, which aims to find a cure for T1D in six years. “We now understand stem cell transplants can succeed in treating diabetes for some, but not in others, and we can predict either outcome before the therapy is administered by 'reading' the immune signature of the patient with a novel nanotechnology that I developed.” An international team of researchers, including Roep, conducted the trial in Brazil. It showed that autologous hematopoietic stem cell transplantation (AHSCT), which uses a person’s own stem cells, increases C-peptide levels — that show how much insulin is being made by the pancreas — and induces insulin independence in patients with T1D. This is possible because the transplanted stem cells are able to balance the immune system. The study also aimed to understand why some patients saw long-term clinical benefit from the transplantation while others did not. Twenty-one T1D patie Continue reading >>
Type 1 Diabetes | The Stem Cellar
Diabetes Research Institute scientists have confirmed that the unique stem cells reside within large ducts of the human pancreas. Two such ducts (green) surrounded by three islets (white) are shown. [Diabetes Research Institute Foundation] Chemo- and radiation-free blood stem cell transplant showing promise Bubble baby disease, also known as severe combined immunodeficiency (SCID), is an inherited disorder that leaves newborns without an effective immune system. Currently, the only approved treatment for SCID is a blood stem cell transplant, in which the patients defective immune system cells are eliminated by chemotherapy or radiation to clear out space for cells from a healthy, matched donor. Even though the disease can be fatal, physicians loathe to perform a stem cell transplant on bubble baby patients: Physicians often choose not to give chemotherapy or radiation to young children with SCID because there are lifelong effects: neurological impairment, growth delays, infertility, risk of cancer, etc., says Judith Shizuru, MD, PhD, professor of medicine at Stanford University. To avoid these complications, Dr. Shizuru is currently running a CIRM-funded clinical trial testing a gentler approach to prepare patients for blood stem cell transplants. She presented promising, preliminary results of the trial on Tuesday at the annual meeting ofStanfords Center for Definitive and Curative Medicine. Trial participants are receiving a protein antibody called CD117 before their stem cell transplant. Previous studies in animals showed that this antibody binds to the surface of blood stem cells and blocks the action of a factor which is required for stem cell survival. This property of CD117 provides a means to get rid of blood stem cells without radiation or chemotherapy. Early Continue reading >>
Clinical Trials Viacyte, Inc.
PEC-Encap Combination Product is inthe Clinic ViaCyte, Inc.announced in July 2014 that it had filed its first Investigational New Drug application (IND) with the United States Food and Drug Administration (FDA) seeking to initiate a Phase 1/2 clinical trial in patients with type 1 diabetes, and in August 2014 the IND was accepted, allowing clinical testing to commence. The first patients were implanted at UC San Diego. In 2015, ViaCyte announced the allowance of PEC-Encap clinical testing in Canada, and a second site opened in Edmonton, Alberta. The first-in-human STEP ONE* trial isevaluating the safety and efficacy of ViaCytes PEC-Encap (a.k.a. VC-01) product candidate, a stem cell-derived, encapsulated cell replacement therapy. STEP ONE is the first trial in the world investigating a stem cell-derived beta cell replacement therapy for diabetes. *Safety,Tolerability, andEfficacy of VC-01 CombinationProduct in TypeOneDiabetes PEC-Direct Combination Product is inthe Clinic In 2017, ViaCyte, Inc. announced the allowance of clinical testing for its PEC-Direct cell replacement product candidate for high-risk type 1 diabetes. With the STEP ONE trial underway, and the addition of W. L. Gore & Associates as collaborators to optimize the Encaptra cell delivery system, ViaCyte felt that the PEC-Direct approach might be the most rapid way to get the invaluable PEC-01 cell replacement therapy to those who need it most. The PEC-Direct trial is now underway in the U.S. and Canada, with clinical sites established at University of Alberta, UC San Diego, and the University of Minnesota. The initial phase of clinical investigation isfocusing on the safety of the cell replacement therapy combination products in patients. Subsequent phases will focus on establishing the doses required fo Continue reading >>
Jdrf Partner Viacyte To Immediately Initiate Type 1 Diabetes Clinical Trial
JDRF Partner ViaCyte to Immediately Initiate Type 1 Diabetes Clinical Trial JDRF Partner ViaCyte to Immediately Initiate Type 1 Diabetes Clinical Trial JDRF Partner ViaCyte to Immediately Initiate Type 1 Diabetes Clinical Trial JDRFs partner ViaCyte recently announced the U.S. Food and Drug Administration (FDA) is allowing them to move forward with a clinical trial of its innovative type 1 diabetes (T1D) encapsulated cell replacement therapy called VC-01 product candidate. The company plans to immediately initiate the first ever clinical evaluation of a stem cell-derived islet replacement therapy for the treatment of people with T1D. The trial will enroll approximately 40 people at multiple clinical sites. On behalf of JDRF, I congratulate ViaCyte for this milestone, said Derek Rapp, JDRF president and CEO. We are extremely pleased the FDA has allowed the company to move forward with a human clinical trial of its innovative type 1 diabetes (T1D) encapsulated cell replacement therapy called VC-01 product candidate. We are hopeful that beta cell encapsulation therapy could one day virtually eliminate the daily management burden for those living with T1D. An important goal of the trial will be to assess the safety of the VC-01 product candidate. Other key information to be collected will include: measures of insulin production to provide evidence of potential efficacy, changes to the amount of administered injected insulin, and the incidence of hypoglycemia. JDRF is providing key funding to support ViaCytes first ever clinical study of this exciting experimental therapy. JDRF has made its encapsulation research program a priority because of its potential to transform the way individuals with T1D manage their disease. For more information or to support JDRFs encapsulation Continue reading >>
Phase 2 Clinical Trial For Type 1 Diabetes Reaches Halfway Treatment Point
The Sanford Project: T-Rex Study, a Phase 2 clinical trial conducted collaboratively by Sanford Health and Caladrius Biosciences, Inc., (Caladrius), has reached the halfway point for enrollment and treatment. The project is studying the potential of CLBS03, Caladrius' cell therapy consisting of each patient's own regulatory T cells, or Tregs, to help the body fight type 1 diabetes. So far, 56 of a planned 111 participants have been treated. An interim analysis of early therapeutic effect will occur after the six-month post-treatment follow-up visit of the first 56 subjects, with results expected to be announced in late 2017 or early 2018. The Sanford Project: T-Rex Study enrolled 19 participants in the first cohort of this phase 2 trial. A planned pause from August to November 2016 allowed the independent Data Safety Monitoring Board to review the safety of the study until that point, and it was recommended to begin enrolling the second cohort of participants. Following this review, the minimum age for participation was lowered from 12 to 8. Sanford sites in Sioux Falls and Fargo, N.D., together with 10 other sites around the country, are accepting qualifying participants. Kurt Griffin, M.D., Ph.D., director of clinical trials for the Sanford Project, and Fargo-based pediatric endocrinologist Luis Casas, M.D., are the study's principal investigators. Individuals with type 1 diabetes experience a loss of insulin-producing beta cells. The Sanford Project: T-Rex Study is exploring if expanding the body's supply of Treg cells can help prevent the immune system from mistakenly destroying insulin-producing beta cells. Participants are randomized to either the treatment or placebo groups. For those randomized to the treatment group, the participant's own Treg cells are extract Continue reading >>
- Mass. General Hospital launches phase II trial of BCG vaccine to reverse type 1 diabetes
- Immunotherapy treatment shown safe in type 1 diabetes clinical trial
- Relative effectiveness of insulin pump treatment over multiple daily injections and structured education during flexible intensive insulin treatment for type 1 diabetes: cluster randomised trial (REPOSE)
Clinical Trials And The Type 1 Diabetes Cure
WRITTEN BY: Stephen Gitelman, MD I am often asked the question, “Where is the cure for Type 1 diabetes (T1D)?” For those with long-standing diabetes, we are very close to replicating insulin producing beta cell functionality or the actual replacement of those cells — either with closed loop systems with continuous glucose sensor driving an insulin pump, or use of replacement beta cells derived from stem cells. However, as a Pediatrician, I think the ultimate cure for T1D will be prevention. Why can’t we screen and predict who is at risk, and then prevent someone from getting Type 1 diabetes in the first place? It turns out that T1D occurs in about 1 in 300 people in the general population, but if you already have someone in your family with diabetes, like a brother or sister, then the risk jumps to a 1 in 20 chance of developing Type 1 diabetes. This is why researchers in an NIH sponsored international research effort called TrialNet have been focusing prevention efforts on families with at least one T1D. T1D results from both underlying genetic risk and environmental exposures, but researchers are still working to determine these specific factors. Thanks to some of this work, we now have the ability to predict who will get T1D, in some cases as long as 10-20 years before it happens (see figure). Researchers use three different pieces of information for prediction. First, we look at the immune system. This is done with a simple blood test, measuring up to five different autoantibodies that the immune system might produce against beta cells. If no abnormality is found, then your risk of developing Type 1 diabetes in the near future is very low. However, if there is any abnormality found in the antibody profile, then additional tests are necessary to further defin Continue reading >>
Diabetes Mellitus, Type 1 Clinical Trials
Do you have Type 1 Diabetes? All trial-related visits, tests, and medications will be provided to participants at no cost. In addition, compensation for time and/or travel may be provided. We are currently seeking volunteers who are diagnosed with Type 1 Diabetes and who are currently being treated with basal and bolus insulin. This study is comparing an investigational basal insulin to Lantus insulin. Half of the participants will be entered into a year-long study and will take the investigational ... You screen their Internet access. You screen their movies. Have you screened their blood for increased risk of Type 1 diabetes? A blood test can identify risk for type 1 diabetes up to 10 years before symptoms appear. This test is offered at no cost to people who have a ... People with Type I Diabetes Mellitus are asked to participate in a research study being conducted by University Physicians Group. You may be eligible to participate in this study if you: Are a male or female between the ages of 18 and 65 Have a diagnosis of Type ... One-day visit study to evaluate a new glucose meter Patient Inclusion Criteria: 12 years or older Must be able to perform self monitoring glucose testing without assistance Must be able to speak, read and write English Do you have Type 1 Diabetes? Are your blood sugar levels still too high on your current insulin regimen? If you are a man or woman over the age of 18, you may be eligible to participate in a clinical research study evaluating the safety and effectiveness of an investigational form of insulin in reducing blood sugar levels in individuals with Type 1 Diabetes. There is no cost to ... Continue reading >>
4 Promising New And Upcoming Clinical Trials For Type 1 Diabetes
Type 1 Diabetes is a disease where your own immune system mistakenly attack your “pancreatic islets”- small clusters of cells in the pancreas that contain insulin-producing “beta” cells. There is currently no cure for Type 1 Diabetes, although it can be managed. Type 1 diabetics must carefully time when and what they eat, monitor their blood glucose by pricking their fingers, and routinely inject themselves with insulin. This life-long struggle can be very annoying for patients. Furthermore, even with careful management, long-term complications generally develop over time. These complications include kidney failure, damage to the retina, heart disease, and foot ulcers. This highlights the need to find better ways to manage the disease. In this article, we have summarised 4 clinical trials for Type 1 Diabetes. We explain the scientific reasoning behind each treatment and what the current findings are (including any potential side effects). NOTE: We did not receive any money from any of the following companies to write this article, nor did they ask us to publicise them. The trials are here because they stemmed from solid scientific research. Before taking any actions, please consult your healthcare provider to determine whether or not you might benefit from these treatments. 1) The “T-Rex” study (T-regulatory cell therapy), Caladrius Biosciences, USA What is the scientific basis of the study? The name of the clinical trial is a pun on T-regs, short for “T-Regulatory cells”, which are a type of white blood cells involved in your immune system. T-regs distinguish which cells are harmful to your body, and which cells are not. So, they are crucial in preventing your immune system from mistakenly destroying your own healthy cells. As mentioned earlier, this is Continue reading >>
Clinical Trials Of Stem Cell-based "functional Cure" For Type 1 Diabetes Underway
2 pictures A human clinical trial examining the safety and efficacy of a "functional cure" for type 1 diabetes is currently underway. Trials of the novel islet cell replacement therapy developed by ViaCyte involve a device containing stem cells being implanted into a patient with type 1 diabetes. It's hoped these cells will then mature into human islet tissue with insulin-producing beta cells that produce insulin on demand. So far, 2017 is proving to be an exciting year for breakthroughs in diabetes research, particularly in regards to treatments for type 1 diabetes. We have seen two very promising developments based in gene therapy, while a human trial for a type 1 diabetes vaccine is currently underway in Finland targeting a viral group known to trigger the disease. The new treatment developed by ViaCyte is being described as a "functional cure" in that it could replace the missing insulin cells in a diabetic patient, as opposed to a more direct "cure" which would address the autoimmune roots of the disease. The treatment being trialed piggybacks off prior working knowledge of islet cell transplantation being successful in patients with type 1 diabetes. For some time, patients with the disease have been treated with pancreatic cells from organ donors, successfully liberating them from insulin injections. "Islet transplants have been used to successfully treat patients with unstable, high-risk type 1 diabetes, but the procedure has limitations, including a very limited supply of donor organs and challenges in obtaining reliable and consistent islet preparations," says trial investigator James Shapiro. "An effective stem cell-derived islet replacement therapy would solve these issues and has the potential to help a greater number of people." The new treatment involves a Continue reading >>
Diabetes Stem Cell Clinical Trials And Their Potential
Read about the current state of stem cell-based diabetes treatments. Stem cell and regenerative medicine technologies have the potential to cure diabetes, although we are certainly far from such a cure. Studies on rodents indicate that curative stem cell therapy of diabetes is possible, but experimental human trials applying non-myeloablative autologous hematopoietic stem cell transplantation or autologous umbilical cord blood infusions to patients with type 1 diabetes show mixed results. There have been some noteworthy recent studies on stem cell educator therapy and the transplantation of human beta cells containing a bioreactor to a patient with type 1 diabetes without the need for immunosuppression. Profil Germany has a positive attitude to approaches to diabetes therapy based on stem cells and regenerative medicine provided that they meet the highest ethical standards and have the clear potential to overcome the limitations inherent in current insulin therapies. The latter include: under-insulinization of the liver and pancreas accompanied by over-insulinization of peripheral tissues; impaired glucagon suppression by the beta cells leading to glycemic volatility; and an imperfect match of basal and meal-related insulin requirements. Moreover, with current therapies, the natural pulsatility of insulin exposure is not restored so there is no de facto cure of diabetes. On the other hand, the relative success of recent insulin therapies has set high standards and made any therapy with significant negative side effects, such as long-term immunosuppression, unacceptable. Profil Germany have been involved in various pharmaceutical and treatment development projects that focused on patients endogenous repair potential. Drugs that protect beta cells from death and/or stimu Continue reading >>
Reversal Of Type 1 Diabetes In Children By Stem Cell Educator Therapy
You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Reversal of Type 1 Diabetes in Children by Stem Cell Educator Therapy The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. ClinicalTrials.gov Identifier: NCT01996228 Verified March 2014 by Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc.. Second Xiangya Hospital of Central South University Information provided by (Responsible Party): Yong Zhao, MD, PhD, Tianhe Stem Cell Biotechnologies Inc. Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information Type 1 diabetes (T1D) is an autoimmune disease that usually occurs in children and reduces their pancreatic islet beta cells and thereby limits insulin production. Millions of individuals worldwide have T1D, and the number of children with diagnosed or undiagnosed T1D is increasing annually. Insulin supplementation is not a cure. It does not halt the persistent autoimmune response, nor can it reliably prevent devastating complications such as neuronal and cardiovascular diseases, blindness, and kidney failure. A true cure has proven elusive despite intensive research pressure over the past 25 years. Notably, Dr.Zhao and his team have successfully developed a groundbreaking technology Stem Cell Educator therapy (Zhao Y, et al.BMC Medicine 2011, 2012). To date, clinical trials in adult patients have demonstrated the safety and efficacy of Stem Cell Educator therapy for the treatment of T1D and other autoimmune-associated diseases. Here, the investigators will eva Continue reading >>
Clinical Trials For Type 1 Diabetes
Share on Facebook Tweet it Email it Print it Thanks to funding from Proposition 71, Californias $3 billion investment in stem cell research, and the state funding entity it created, the California Institute for Regenerative Medicine (CIRM), there are now 36 human clinical trials in various stages of progress, including a trial for sickle cell disease. Description: Clinical trial of stem cell gene therapy for Type 1 Diabetes CIRM Funding Brief: Type 1 diabetes develops when the bodys own immune system kills the insulin-producing beta cells in the pancreas. Without insulin, blood sugar levels can spike, and cause organ and nerve damage, heart disease, limb amputation, or even death. This clinical trial will use human embryonic stem therapy to replace the lost beta cells that cause Type 1 diabetes. The partnership is developing a beta cell replacement therapy for insulin-dependent diabetes. If successful, the therapy will go beyond insulin function, and will perform the full array of normal beta cell functions, including responding in a more physiological manner than manual or mechanized insulin administration. Read more at CIRM. Principal Investigator: Robert Henry, James Shapiro Institution:UCSD, University of Alberta, ViaCyte, Inc. As this clinical trial moves forward, we will update this page. Check back here for future developments. As scientists and patient advocates build on the progress that Proposition 71 has enabled, we must keep the momentum going, understanding that there is still much work to be done. We must remember that human trials will celebrate successes; but, barriers will surface, along with complications and challenges, so patience and understanding of the scientific discovery process is essential. Even the setbacks will provide critical knowledge th Continue reading >>
Viacyte Treats First Patients In Pec-direct Stem Cell Trial For Type 1diabetes
ViaCyte treats first patients in PEC-Direct stem cell trial for type 1diabetes Today, ViaCyte shared an update on its latest clinical trial for type 1 diabetes (T1D). The company is based in San Diego and is developing two stem cell-based products that attempt to replace the pancreatic beta islet cells that are attacked by the immune system of patients with T1D. Their first product, called VC-01 or PEC-Encap, is an implantable device containing embryonic stem cells that develop into pancreatic progenitor cells, which are precursors to the islet cells destroyed by T1D. The hope is that when this device is transplanted under a patients skin, the progenitor cells will develop into mature insulin-secreting cells that can properly regulate the glucose levels in a patients blood. Because the cells are encapsulated in a protective semi-permeable membrane, hormones and nutrients can pass in and out of the device, but the implanted cells are guarded against the patients immune system. VC-01 is currently being tested in a Phase 1 clinical trial that is funded CIRM . ViaCyte now has a second product called VC-02, or PEC-Direct, that also transplants pancreatic progenitors but in a device that allows a patients blood vessels to make direct contact with the implanted cells. This direct vascularization approach is being tested in patients that are at high risk for severe complications associated with T1D including hypoglycemia unawareness a condition where patients fail to recognize when their blood glucose level drops to dangerously low levels because the typical symptoms of hypoglycemia fail to appear. ViaCytes PEC-Direct device allows a patients blood vessels to integrate and make contact with the transplanted beta cells. Today, the ViaCyte announced in a press release that it ha Continue reading >>
