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Diabetes Stem Cell 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 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 >>

Current Progress Of Human Trials Using Stem Cell Therapy As A Treatment For Diabetes Mellitus

Current Progress Of Human Trials Using Stem Cell Therapy As A Treatment For Diabetes Mellitus

Current progress of human trials using stem cell therapy as a treatment for diabetes mellitus 1Georgetown University School of Medicine, Georgetown University Medical Center, Washington DC, USA 2Department of Biochemistry and Molecular and Cellular Biology, Georgetown University Medical Center, Washington DC, USA 1Georgetown University School of Medicine, Georgetown University Medical Center, Washington DC, USA 2Department of Biochemistry and Molecular and Cellular Biology, Georgetown University Medical Center, Washington DC, USA Address correspondence to: Dr. G. Ian Gallicano, Department of Biochemistry and Molecular and Cellular Biology, Georgetown University Medical Center, NE203 Med-Dent Building, Box 571436, 3900 Reservoir Road, NW, Washington DC, USA. Tel: 202-687-0228; Fax: 202-687-1823; E-mail: [email protected] This article has been cited by other articles in PMC. Diabetes mellitus affects millions of people worldwide, and is associated with serious complications that affect nearly all body systems. Because of the severity of this global health concern, there is a great deal of research being performed on alternative treatments and possible cures. Previous treatments for diabetes have included exogenous insulin injection and pancreatic islet transplantations. These treatment methods have several limitations; thus, the use of stem cells in treating diabetes is currently a significant area of research. This review outlines current research on stem cell therapy for diabetes mellitus. Numerous studies have been performed on animals using various types of stem cells, including mesenchymal stem cells and embryonic stem cells. Moreover, results and limitations of animal studies have been confirmed in various clinical trials. Overall, stem cell treatment shows prospe Continue reading >>

Diabetes Stem Cell Clinical Trials And Their Potential

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 >>

Phase 2 Clinical Trial For Type 1 Diabetes Reaches Halfway Treatment Point

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 >>

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

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 >>

Stem Cell Factory Opens Door For Trials Of Personalized Diabetes Treatment

Stem Cell Factory Opens Door For Trials Of Personalized Diabetes Treatment

In a step that could lead to a new diabetes treatment, several Boston-area hospitals have teamed up with the Harvard Stem Cell Institute and biotech Semma Therapeutics tomake personalized cell-based therapiesand organize clinical trials. It is one of several initiatives around the country aimed at manufacturing cell-derived treatments, as the hope for such therapiescreates a demand for the productionof the cells. In patients with type 1 diabetes , the immune system attacks the pancreatic cells that produce insulin, called beta cells. Doctors have for years transplanted beta cells from dead donors into patients, but the supplyis insufficient for the millions of people with type 1 diabetes, and patients bodies sometimes reject the donor cells. The new program, officially called the Boston Autologous Islet Replacement Program, could provide enough high-quality beta cells needed to treat patients in upcomingclinical trials. And the cells that will be transplanted into these volunteerswill be derived from their ownblood cells, cutting the risk of rejection. For the first trial, which wont start for at least three years, researchers intend to transplant the cells into people who have had their pancreas removed because of pancreatitis or another condition. If the treatment proves effective and safe, doctors could conduct another study with diabetic patients. Diabetes rose fourfold over last 25 years, WHO says As part of the collaboration, clinicians at Brigham and Womens Hospital and the Joslin Diabetes Center will recruit patients. Experts at the Dana-Farber Cancer Institute will derive the stem cells from the patients own blood cells creating what are called induced pluripotent stem cells and coax them into becoming beta cells. Doctors at the Brigham will then perform the t Continue reading >>

Diabetes | Canadian Stem Cell Foundation

Diabetes | Canadian Stem Cell Foundation

Are there stem cell therapies available for type 1 diabetes? To our knowledge, no stem cell therapy has received Health Canada or U.S. Food and Drug Administration approval for treatment of type 1 diabetes at this time. Patients who are researching their options may come across companies with Web sites or materials that say otherwise and offer fee-based stem cell treatments for curing this disease. Many of these claims are not supported by sound scientific evidence and patients considering these therapies are encouraged to review some of the links below before making crucial decisions about their treatment plan. For the latest developments read our blog entries here . More about stem cell clinical trials for diabetesclick here . (For printed version: How close are we? What do we know about type 1 diabetes? The insulin-producing beta cells of the pancreas are attacked and destroyed by the bodys immune system cells. A persons environment, genetics and the infections they are exposed to over their lifetime all play a role in triggering the attack on beta cells. When the beta cells are destroyed, the production of insulin drops and our cells can no longer take in the sugar glucose. When glucose is left circulating in the blood at very high levels the blood vessels, eyes, kidneys, nerves and heart can be damaged. If type 1 diabetes is not diagnosed and treated in time with injections of insulin, a patient could fall into a life-threatening coma. Just a few teaspoonfuls of pancreatic islet cells can temporarily reverse type 1 diabetes. There is a shortage of donor pancreatic islet cells for treating patients with type 1 diabetes. Type 1 diabetes is an ideal candidate for a stem cell therapy because the disease can be traced to the loss of a single cell type the beta cell. St Continue reading >>

Documenting Viacyte's Stem Cell Diabetes Trial

Documenting Viacyte's Stem Cell Diabetes Trial

Nearly 18 months into a breakthrough stem cell trial for type 1 diabetes, significant positive results are emerging. ViaCyte , a leader in stem cell therapies for diabetes, is conducting this first human trial of its kind. And a husband/wife team is producing the first documentary of its kind. They are filming the trial results as they occur. Almost everyone with type 1 diabetes heard upon their diagnosis, There will be a cure in five to ten years. For me that was forty-four years ago this month. Why do we still not have a cure for diabetes Nearly a century after the discovery of insulin? Given approximately 1.25 million American children and adults have type 1 diabetes? With nearly 80,000 newly diagnosed young people every year? With type 1 and type 2 diabetes only rising? 30 million Americans and 415,000,000 people globally suffering with both types of diabetes Given diabetes will be a 561 billion dollar global health expenditure by 2030? When its the seventh leading cause of death? Why does a diabetes cure take so long, and should we still be hoping? Filmmakers Lisa Hepner and Guy Mossman think we should. They also want us to understand whats involved in cure research and why its a laborious and intricate process. Filming the Trial That May Lead to a Cure Hepner and Mossman are the directors of the feature documentary, The Human Trial . Their crew has exclusive real-time access to a top lab conducting the first human cell encapsulation research trial of its kind. The Human Trial is following one research team and a handful of trial patients as they move from the lab through the first two years of the Phase 1/2 clinical trial. For Hepner, who has had type 1 diabetes for twenty five years, making this film is personal. While Im hoping this trial may be the breakthroug Continue reading >>

Stem Cell Therapy For Type 1 Diabetes Mellitus

Stem Cell Therapy For Type 1 Diabetes Mellitus

You have reached the maximum number of saved studies (100). Please remove one or more studies before adding more. Stem Cell Therapy for Type 1 Diabetes Mellitus 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: NCT01143168 Verified June 2010 by Cellonis Biotechnology Co. Ltd.. Recruitment status was: Not yet recruiting Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information The purpose of this study is to evaluate the feasibility, efficacy and safety of transplantation therapy using bone marrow mononuclear cells and umbilical cord mesenchymal stem cells for patients with type 1 diabetes mellitus Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells To evaluate the feasibility, safety and efficacy of transplantation using autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells in patients with type 1 diabetes mellitus. A Pilot Study on Transplantation Therapy Using Autologous Bone Marrow Mononuclear Cells and Umbilical Cord Mesenchymal Stem Cells in Patients With Type 1 Diabetes Mellitus Biological: autologous bone marrow mononuclear cells and umbilical cord mesenchymal stem cells First Transplantation: after finishing all required examines according to protocol on Day 0, ABM-MNCs + UCMSCs are transplanted through pancreas artery percutaneously; Second Transplantation: after finishing all required examines on Day 71, BM-MNCs UCMSCs are transplanted intravenously; Third Transplantation: after finishing all required examines Continue reading >>

Clinical Trials Of Stem Cell-based

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 >>

Clinical Trials Viacyte, Inc.

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 >>

Type 1 Diabetes Stem Cell Therapy Trials Progressing

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 >>

Clinical Trials For Type 1 Diabetes

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 >>

4 Promising New And Upcoming Clinical Trials For Type 1 Diabetes

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 >>

Updates On Harvard’s Diabetes Stem Cell Research From Ada 2015

Updates On Harvard’s Diabetes Stem Cell Research From Ada 2015

Twitter Summary: @Harvard #diabetes stem cell lab wows crowd at #2015ADA, plans to produce full pancreatic islets w/ beta + alpha cells. Still early stages. There was a lot of interest this ADA in the Harvard Stem Cell Institute’s diabetes research, which has previously shown the ability to produce mature, insulin-producing beta cells from human stem cells. These beta cells can effectively cure type 1 diabetes in mice. (Normally, beta cells produce insulin and are found in the pancreas). While other groups are also working on stem cell based therapies for diabetes, the Harvard group is unique in that they are able to produce mature beta cells from stem cells. For comparison, the prominent diabetes stem cell research group at ViaCyte is only able to create “parent” cells that, after implantation in the body, could later develop into functional beta cells. Another group called BetaLogics, which is owned by J&J, can produce human “beta-like” cells that, while not identical to human beta cells, would already be mature (i.e. able to produce insulin in response to glucose levels) upon implantation. The Harvard group can also produce an extremely large quantity of cells, which is a critical need given the current deficit of beta cells for the millions of people with type 1 diabetes and type 2 diabetes who can no longer sufficiently produce insulin. Dr. Douglas Melton from Harvard wowed the crowd with his update on the team’s latest discoveries, most notably the announcement that his team can now not only produce beta cells from stem cells, but also alpha cells (which produce glucagon, another important hormone) and delta cells. All of these cells are found together in ‘islets’ in the pancreas, and Dr. Melton believes that his team will in the future be able to Continue reading >>

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