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Clinical Trials For Type 1 Diabetes Cure

City Of Hope Aims To Cure Type 1 Diabetes In Six Years

City Of Hope Aims To Cure Type 1 Diabetes In Six Years

It’s an extraordinary goal powered by an extraordinary gift. City of Hope’s Diabetes & Metabolism Research Institute is committed to developing a cure for type 1 diabetes (T1D) within six years, fueled by a $50 million funding program led by the Wanek family. It seems an audacious goal for a comprehensive cancer center, but City of Hope has a long history of groundbreaking work in diabetes. Research conducted by City of Hope led to the development of synthetic human insulin, which is still used today by many of the estimated 1.5 million Americans with T1D and 27 million with type 2 diabetes (T2D). “City of Hope is best positioned to take on this challenge,” said Robert W. Stone, president and chief executive officer of City of Hope. “This is thanks to our 40-year institutional legacy of pioneering treatment and research advances in diabetes.” The funding for the transformative research needed to embark on such an endeavor is led by a gift from the Wanek family, which owns Ashley Furniture Industries, the world’s largest home furniture manufacturer. “City of Hope scientists’ research has revolutionized the understanding and treatment of diabetes,” said Todd Wanek, chief executive officer of Ashley Furniture, speaking on behalf of his family. “It continues today as physicians and scientists gain systemic understanding of diabetes as a complex, multifaceted disease.” Through the generosity of the family and gifts from an anonymous donor, City of Hope will be able to devote more than $50 million over the next six years to an unprecedented research effort: The Wanek Family Project for Type 1 Diabetes at City of Hope. A Multifaceted Approach The Wanek Family Project will result in the creation of a series of highly focused programs at City of Hope. The 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 >>

Clinical Trials: American Diabetes Association

Clinical Trials: American Diabetes Association

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 glucose metabolism. 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. By jointly identifying and validating promising biological targets of disease, the partnership strives to increase the number of new diagnostics and therapies for patients and reduce the time and cost of developing them. The Biomarkers Consortium is a public-private biomedical research partnership managed by the Foundation for the National Institutes of Health that endeavors to discover, develop, and qualify biological markers (biomarkers) to support new drug development, preventive medicine, and medical diagnostics. By policy , the American Diabetes Association does not list or promote specific clinical trials other than the trials above in which it is a formal collaborator. This policy also applies to patient surveys. There are far too many trials and surveys being conducted at any given time for the Association to be able to evaluate them on an individual basis. However, the following resources from the Food and Drug Administration and the National Institutes of Health provide more information about clinical trials and how to determine which trials are being conducted in a location near you. Continue reading >>

Everything You Need To Know About Diabetes Clinical Trials

Everything You Need To Know About Diabetes Clinical Trials

Consent form and information sheet detailing benefits, risks and compensation for participation Different types of Diabetes Clinical trials TrialNet is an international platform for clinical trials in type 1 diabetes with multiple trials conducted at once under a collaborative umbrella. The platform consists of 18 Clinical Centers spread throughout the globe with participation from about 100 Affiliates as collaborating clinical sites.3 Type 1 Diabetes There are numerous ongoing trials with the most recent one by ViaCyte Inc. which is a private company in regenerative medicine.4 The company has recently launched first phase of clinical trial for a stem-cell derived product candidate (VC-01) developed using two technologies: stem cell combined with an innovative delivery device called Encaptra used to deliver a dose of cells in various body locations. 4 Type 2 Diabetes This is an NIH-funded type 2 diabetes trial focusing on patients already on metformin medication. The trial is known as GRADE and involves assigning randomized participants to 1-4 commonly used glucose-lowering drugs plus metformin and followed for 7 years.5 The goal is to find the optimal combination of diabetes drugs for good glycemic control in long-term treatment of type 2 diabetes populations.5 Type 1 Diabetes During early stages of type 1 diabetes, up to 40% of pancreas cells make insulin which can still contribute to blood sugar control. For the first time in the world, a collaborative UK research team is using a peptide with memory to test the safety of a human vaccine for type 1 diabetes.6 Type 2 Diabetes Pharmaleads a French biotech company has initiated one of the first trials ever to investigate the potential of a novel drug for chronic pain in diabetic neuropathy.7 Expectation of participants 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 >>

Islet Cell Transplant Program For Diabetes Cure (clinical Trial)

Islet Cell Transplant Program For Diabetes Cure (clinical Trial)

Islet cell transplant program for Diabetes cure (clinical trial) Hi, Ive recently qualified for the islet cell transplant program at City of Hope. Im wondering if anyone in this community has participated in this program? My next step is to provide additional information to them (Auth for release of medical information and one months data from my CGM). Thank you. Ive recently qualified for the islet cell transplant program at City of Hope. I didnt recognize the name of the city. Is the study location northeast of Los Angeles near Duarte, California? Good for you for volunteering! Please keep us posted with updates. City of Hope is actually one of the research organizations Beyond Type 1 donates money to. Is this the research you will be participating? Thank-you for stepping forward !! Im curious as to how it goes and how well you cope with the anti-rejection drugs. It appears that City of Hope researchers are experimenting with regulating instead of suppressing the immune system. From @Mila s link posted above. At City of Hope, our experts are advancing breakthrough interventions that correct autoimmunity by regulating instead of suppressing the immune system. Our innovative approaches aim to restore a balanced immune system in order to stop its attack on insulin-producing beta cells. We are also endeavoring to reawaken or boost a patients remaining beta cells, or regenerate beta cells, in order to help them produce insulin on their own. These therapies represent a radical departure from traditional treatment methods that target the consequences of the disease rather than its cause (insulin insufficiency). We are also conducting research aimed at balancing the immune system by expanding and re-engineering immune cells that control and direct the fight against disease. Continue reading >>

Clinical Trials And The Type 1 Diabetes Cure

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 >>

Type 1 Diabetes Pediatric Research And Clinical Trials

Type 1 Diabetes Pediatric Research And Clinical Trials

Type 1 Diabetes Pediatric Research and Clinical Trials Because diabetes can require lifelong management, researchers at Childrens are investigating the earliest stages of the disease in order to understand how the disease develops and how it can be treated. Areas of research focus on: how to keep the insulin-secreting beta cells alive as a method both for treatment and prevention of Type I diabetes tempering autoimmune activity in Type I diabetes long-term follow up of diabetic patients for quality of life genetic factors for obesity, which can lead to Type II diabetes genetic factors for diabetes-related kidney failure Childrens Hospital Bostons Diabetes Program is participating in the Diabetes Prevention Trial-Type 1 (DPT-1)an ongoing nationwide clinical trial to determine whether type 1 diabetes can be prevented or delayed in people at risk for developing the disease. Preliminary studies conducted in animals have shown that it may be possible to prevent type 1 diabetes with oral insulin or insulin by injection. In animal studies, low doses of insulin by injection have successfully prevented diabetes, and in human studies, insulin injections have preserved the insulin-producing cells in people with pre-diabetes or in the early stages of diabetes. If youre interested in participating, or have questions about the clinical trial, please contact Dr. Joseph Wolfsdorf, Director of Childrens Diabetes Program, at the Division of Endocrinology, 617-355-7476. Learn more about the trial . Tracking type 1 diabetes in Massachusetts In addition to developing a hospital registry, researchers are also working with the Commonwealth of Massachusetts to track the increase of type 1 diabetes in the state. As part of the effort to understand the development of genetic diseases, Childrens 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 >>

Diabetes Mellitus, Type 1 Clinical Trials

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 >>

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 >>

Searching For A Cure For Type 1 Diabetes Through Clinical Trials

Searching For A Cure For Type 1 Diabetes Through Clinical Trials

Searching for a cure for type 1 diabetes through clinical trials Medical costs are 2.3 times higher for a person who has been diagnosed with diabetes . The most common treatment for Type 1 diabetes is through insulin injections. Yet, the injections cannot prevent the dramatic swings in blood sugar levels that can affect quality of life. Current research into complexity and alternative treatments is directed toward control of blood sugar and management of symptoms through the following ways: Medications that influence the kidney’s role in reducing blood sugar. Reducing the dramatic swings in blood sugar with insulin analogs and other drugs. Alternative delivery methods, such as oral or inhaled, may alleviate the pain related to multiple injections per day. Lowering the costs and frequency of use associated with medications. Because of the efficacy shown in type 2 diabetes research, two new classes of drugs are being tested on type 1 patients. The first class is SGLT-2 (Sodium-glucose cotransporter). In type 2 diabetics, SGLT-2 “reduced total mortality by 32%,” remarked Louis B. Chaykin, MD, a physician and endocrinologist at Meridien Research. “Mortality due to cardiovascular disease was reduced by 38%. This was a study that involved over 7,000 participants around the world!” The results were significant enough to encourage studies on type 1 diabetics. “Also, the GLP-1 class of drugs demonstrated a significant reduction in the cardiovascular disease and total mortality.” Clucagon-like peptide-1 is another class of medication that targets the incretin system. Despite the advances in therapies for diabetes, such as different types of insulin and mechanical devices to monitor and deliver medications, diabetes is the 7th leading cause of death in America. Continue reading >>

A Vaccine For Type 1 Diabetes Begins Human Trials In 2018

A Vaccine For Type 1 Diabetes Begins Human Trials In 2018

A prototype vaccine, decades in the making, that could prevent type 1 diabetes in children is ready to start clinical trials in 2018. It's not a cure, and it won't eliminate the disease altogether, but the vaccine is expected to provide immunity against a virus that has been found to trigger the body's defences into attacking itself, potentially reducing the number of new diabetes cases each year. Over two decades of research led by the University of Tampere in Finland has already provided solid evidence linking a type of virus called coxsackievirus B1 with an autoimmune reaction that causes the body to destroy cells in its own pancreas. The type 1 form of diabetes – not to be confused with the more prevalent type 2 variety that tends to affect individuals later in life – is a decreased ability to produce the insulin used by the body's cells to absorb glucose out of the blood. This loss of insulin is the result of pancreatic tissue called beta cells being destroyed by the body's own immune system, often within the first few years of life. It's something of a mystery as to why the body identifies beta cells as foreign, though there could be a genetic link producing variations of human leukocyte markers, which act as the cell's 'ID tags'. No doubt it's complex, and there are numerous ways this process can be triggered. One example established by virologist Heikki Hyöty from the University of Tampere is an infection by a type of enterovirus. Enteroviruses are nasty pieces of work; you might be most familiar with polio, but they can also cause hand, foot and mouth disease, meningitis and myocarditis. There has been suspicion of a link between this group of pathogens and diabetes for a number of years, but it took time to nail down the prime suspects. In 2014, Hyöty an Continue reading >>

Clinical Trial Studying Type 1 Diabetes Reaches Full Enrollment

Clinical Trial Studying Type 1 Diabetes Reaches Full Enrollment

Clinical trial studying type 1 diabetes reaches full enrollment A clinical trial studying type 1 diabetes has reached full enrollment. The Sanford Project: T-Rex Study, a Phase 2 clinical trial conducted collaboratively by Sanford Health and Caladrius Biosciences, Inc., (Caladrius)(Nasdaq: CLBS), has completed enrollment of 110 children with type 1 diabetes. The study started with two sites at Sanford Health in Sioux Falls, South Dakota, and Fargo, North Dakota, and expanded to 13 additional sites across the United States. 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. Subjects will be followed for two years, with the primary endpoint of persistence of insulin production at one year after treatment. A planned, interim analysis of the first half of the participants at six months after treatment is expected by the end of the first quarter. "I am thrilled to have reached this important milestone," said Kurt Griffin, M.D., Ph.D., director of clinical trials for The Sanford Project. "It has taken a tremendous amount of work from a large team to get this far. We still have another year of follow-up before we can really see how this treatment may be working." Griffin and Fargo-based pediatric endocrinologist Luis Casas, M.D., are the study's principal investigators at Sanford Health. Individuals with type 1 diabetes experience a loss of insulin-producing beta cells as their immune system targets these cells inappropriately. Treg cells usually keep the immune system under control, but they are lacking in number and activity in people with type 1 diabetes . The Sanford Project: T-Rex Study is exploring whether expanding the body's supply of Treg cells Continue reading >>

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