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 >>
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 >>
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 >>
Two-year Data From Viacyte's Step One Clinical Trial Presented At Ada 2018
Two-year Data from ViaCyte's STEP ONE Clinical Trial Presented at ADA 2018 Two-year data show survival of mature endocrine islet cells when PEC-Encap is well vascularized; encouraging non-clinical data on modified Encaptra Cell Delivery System may support resuming trial enrollment in 2019. SAN DIEGO, June 23, 2018 /PRNewswire/ -- ViaCyte, Inc. , a privately-held regenerative medicine company, today announced two-year data from Cohort 1 of the ongoing Safety, Tolerability, and Efficacy of VC-01 (PEC-Encap) Product Candidate in Type One Diabetes (STEP ONE) clinical trial. The PEC-Encap combination product candidate consists of stem cell-derived pancreatic progenitor cells (PEC-01) encapsulated in a delivery device called the Encaptra Cell Delivery System. The results indicate that the PEC-Encap product candidate, delivered at a sub-therapeutic dose, has to date been safe and well tolerated. The Encaptra Cell Delivery System appears to protect the implanted cells from allo- and auto-immune rejection and the patients from sensitization. Although consistent and robust engraftment was limited in this study, results showed that when engraftment did occur, viable mature insulin-expressing endocrine islet cells were formed. In some cases, insulin-expressing cells persisted for up to two years after implantation, the longest time point investigated in the study. Details from the STEP ONE trial will be provided in an oral presentation today at 4:00 p.m. ET at the American Diabetes Association's (ADA) 78th Scientific Sessions in Orlando. Howard Foyt, M.D., Ph.D., Vice President, Clinical Development and Chief Medical Officer at ViaCyte said, "PEC-Encap holds the promise of being a functional cure for all patients with type 1 diabetes. The preliminary results from the STEP ONE clin Continue reading >>
Viacyte Announces First Patients Implanted With Pec-direct Islet Cell Replacement Therapy In International Clinical Trial
ViaCyte Announces First Patients Implanted with PEC-Direct Islet Cell Replacement Therapy in International Clinical Trial ViaCyte Announces First Patients Implanted with PEC-Direct Islet Cell Replacement Therapy in International Clinical Trial San Diego, August 1, 2017 ViaCyte, Inc., a privately-held, leading regenerative medicine company, announced today that the first patients have been implanted with the PEC-Direct product candidate, a novel islet cell replacement therapy in development as a functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications. The first implant procedures of the clinical trial took place at the University of Alberta Hospital in Edmonton, Alberta, and the UC San Diego School of Medicines Altman Clinical Trials Research Institute. The goal of the open-label clinical trial is to evaluate the PEC-Direct product candidate for safety and definitive evidence of efficacy. In the coming months, the company expects to expand the trial to additional centers including the University of Minnesota and other sites in the US and Canada. The first cohort of type 1 diabetes patients is receiving multiple small-format cell-filled devices called sentinels in order to evaluate safety and implant viability. These sentinel units will be removed at specific time points and examined histologically to provide early insight into the progression of engraftment and maturation into pancreatic islet cells including insulin-producing beta cells. A second cohort of up to 40 patients is expected to begin enrolling later this year to evaluate both safety and efficacy. The primary efficacy measurement in the trial will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide, in a patie Continue reading >>
Collaboration: The Road To A Cure
Eli and Edythe Broad Center of Regeneration Medicine and Stem Cell Research Home News Collaboration: The Road to a Cure In searching for a cure for diabetes, researchers from UCSF and their partners at ViaCyte, a San Diego biotechnology company, have already cleared some large hurdles. ViaCyte has developed a line of human stem cells that have been specially cultured in the laboratory. When transplanted into rodents, these stem cells turn into insulin-producing beta cells, the cells of the pancreas that are destroyed in diabetics, according to Peter Stock, MD, PhD, principal investigator in the study for UCSF. Being able to generate such cells represents a major milestone on the road to a cure. ViaCytes cells had one potential problem, which has been common to most embryonic stem cell-derived products: While the vast majority form beta cells, there remains an ongoing risk that, occasionally, one or more cells could grow out of control and form a teratoma, or embryonic growth. ViaCyte believes it has solved this problem by encapsulating the pre-beta cells with a small, envelope-like device made of a semipermeable membrane that surgeons implant in the body, explains Eugene Brandon, PhD, ViaCytes director of strategic relations and project management. The envelope contains the embryonic cell-derived pre-beta cell clusters, which form the new beta cells. Sugar in the bloodstream can move through the membrane and be sensed by the beta cells, which then produce insulin in response. The insulin moves back through the membrane into the blood circulation. Having the process take place in the envelope, Brandon says, keeps any potential unwanted growth trapped and easily removed, as cells cannot get through the membrane. The device may also help solve another key problem -- the t Continue reading >>
Viacyte Announces First Patients Implanted In Cohort 2 With Potentially Efficacious Dose Of Pec-direct Islet Cell Replacement Therapy
ViaCyte Announces First Patients Implanted in Cohort 2 with Potentially Efficacious Dose of PEC-Direct Islet Cell Replacement Therapy President and CEO Dr. Paul Laikind will give an update at Biotech Showcase in San Francisco SAN DIEGO, Jan. 5, 2018 /PRNewswire/ -- ViaCyte, Inc. , a privately-held regenerative medicine company, today announced that the first patients have been implanted in Cohort 2 with a potentially efficacious dose of the company's PEC-Direct islet cell replacement therapy. This novel cell replacement therapy is being developed as a potential functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications. Paul Laikind, Ph.D., President and CEO of ViaCyte, will give an update at the 10th Annual Biotech Showcase Conference, on Monday, January 8 at 11:15 a.m. in Franciscan C at the Hilton San Francisco Union Square. The PEC-Direct product candidate is currently in a Phase 1/2 open-label clinical trial at multiple sites in the United States and Canada to evaluate safety and efficacy. Cohort 2 is expected to enroll up to 40 patients, and the primary efficacy measurement will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide, in a patient population that has little to no ability to produce endogenous insulin at the time of enrollment. Other important endpoints will be evaluated including injectable insulin usage and the incidence of hypoglycemic events. "The implantation of a potentially efficacious dose of PEC-Direct marks an important milestone in the development of a functional cure for diabetes," said Dr. Laikind. "While we are developing PEC-Direct to meet a critical unmet medical need for people who are most severely impacted by type 1 diabetes, we are als Continue reading >>
Viacyte Interview On Diabetes Stem Cell Trials & Cool Role Of Gore-tex Tech
ViaCyte Interview on Diabetes Stem Cell Trials & Cool Role of Gore-Tex Tech October 18, 2017 admin diabetes , Interview , stem cell biotech 2 The PEC-Encap (also known as VC-01)productcandidateis designed to deliver pancreatic progenitor cells in an immunoprotective device. The PEC-Directproductcandidatedelivers the pancreatic progenitor cells in a non-immunoprotective device that is designed for direct vascularization of the implanted cells. Click to share on Pocket (Opens in new window) When I think of the promise of stem cells for diabetes, the privately held California stem cell firm ViaCyte is the first biotech that comes to mind now. It has promising stem cell clinical trial work building. Todays post is a new interview with the companys CEO Paul Laikind.For past posts on ViaCyte see here , which includes an interview with Laikind a few years ago. PK: The last time we talked was in March 2015 . Can you please update us on the VC-01 trial? How many patients are enrolled and how many have received the sentinels? PL: As the leaders in this field, VC-01 broke new ground. The STEP ONE clinical trial focused initially on a subtherapeutic dose to provide an assessment of safety and the response to product candidates in patients. The trial for the PEC-Encap (a.k.a. VC-01) product candidate has enrolled approximately 20 patients andbased upon initial findings, the team has decided to pause enrollment in order to make modifications totheEncaptra cell delivery device that are expected to improve engraftment. The ViaCyte team is actively working on such modifications including a collaboration with W. L. Gore. Paul Laikind, President and CEO of ViaCyte Taking what we learned from PEC-Encap, we initiated a clinical trial for PEC-Direct. The PEC-Direct product candidate deliver Continue reading >>
Two-year Data From Viacytes Step One Clinical Trial Presented At Ada 2018
Two-year Data from ViaCytes STEP ONE Clinical Trial Presented at ADA 2018 Two-year Data from ViaCytes STEP ONE Clinical Trial Presented at ADA 2018 Two-year data show survival of mature endocrine islet cells when PEC-Encap is well vascularized; encouraging non-clinical data on modified Encaptra Cell Delivery System may support resuming trial enrollment in 2019. SAN DIEGO, June 23, 2018 ViaCyte, Inc. , a privately-held regenerative medicine company, today announced two-year data from Cohort 1 of the ongoing Safety, Tolerability, and Efficacy of VC-01 (PEC-Encap) Product Candidate in Type One Diabetes (STEP ONE) clinical trial. The PEC-Encap combination product candidate consists of stem cell-derived pancreatic progenitor cells (PEC-01) encapsulated in a delivery device called the Encaptra Cell Delivery System. The results indicate that the PEC-Encap product candidate, delivered at a sub-therapeutic dose, has to date been safe and well tolerated. The Encaptra Cell Delivery System appears to protect the implanted cells from allo- and auto-immune rejection and the patients from sensitization. Although consistent and robust engraftment was limited in this study, results showed that when engraftment did occur, viable mature insulin-expressing endocrine islet cells were formed. In some cases, insulin-expressing cells persisted for up to two years after implantation, the longest time point investigated in the study. Details from the STEP ONE trial will be provided in an oral presentation today at 4:00 p.m. ET at the American Diabetes Associations (ADA) 78th Scientific Sessions in Orlando. Howard Foyt, M.D., Ph.D., Vice President, Clinical Development and Chief Medical Officer at ViaCyte said, PEC-Encap holds the promise of being a functional cure for all patients with type 1 d Continue reading >>
Viacyte Tries Again With Potential Diabetes Cure
After receiving an additional $20 million funding, San Diego’s ViaCyte is testing a new version of its stem cell-based diabetes therapy. With the funding from California’s stem cell agency, or CIRM, ViaCyte plans to get strong evidence within about 18 months to determine whether its implant can restore an internally generated supply of insulin to diabetics. That would produce what ViaCyte calls a functional cure for the disease. The first version of the implant showed mixed results in early human testing, said Paul Laikind, president and chief executive. The second version is designed to better support the insulin-generating cells that substitute for those destroyed in type 1 diabetes. The grant was awarded Sept. 28, bringing ViaCyte’s total from CIRM to more than $51 million. Previous grants were for research and development. The new grant is exclusively for clinical testing. Earlier this month, Laikind discussed plans for privately held ViaCyte at the Cell & Gene Meeting on the Mesa in La Jolla. ViaCyte has to solve two major problems, Laikind said. One is to produce cells that generate insulin and survive in the body for an extended time. The second is to keep the body’s immune system from destroying the cells, derived from human embryonic stem cells. The first version, called PEC-Encap, addressed the problem by shielding the cells inside a semi-permeable membrane. The membrane keeps immune cells out, but allowing nutrients to flow in and insulin to flow out. In some of those tested, the device produced the hoped-for results. When the implants were removed for examination, the cells appeared healthy. “However, this was not the rule,” Laikind said in a presentation at the meeting. In most cases, the implants were covered with fibrous tissue, produced by th Continue reading >>
Viacyte, Inc. First In Kind Cellular Treatment For Diabetes
Transforming the Lives of Patients with Diabetes ViaCyte, Inc., a leader in the emerging field of regenerative medicine, is headquartered in San Diego, California. ViaCyte's innovative products are based on the differentiation of stem cells into pancreatic beta cell precursors (PEC-01), with subcutaneous implantation in a retrievable medical device (Encaptra cell delivery system). Once implanted, the precursor cells mature into endocrine cells that secrete insulin and other hormones in a regulated manner to control blood glucose levels. ViaCyte's goal is a product that can free patients with type 1 and type 2 diabetes from long-term insulin dependence. If successful, ViaCytes products will relieve patients of both the acute challenges and risks, as well as the long-term complications, associated with diabetes. ViaCyte has received substantial financial, scientific, advocacy, and technical support from both the California Institute for Regenerative Medicine (CIRM) and JDRF. Stem Cell-Derived Islet Replacement Therapies ViaCyte is developing islet cell replacement therapy for insulin-requiring diabetes. Our two key products in development deploy the same active component, PEC-01 Cells, but with different delivery technologies and addressing the unmet needs of different patient groups. Continue reading >>
The Story
The Human Trial is a feature-length documentary with unprecedented, real-time access to one of America’s top labs — ViaCyte in San Diego. This groundbreaking film follows the team’s triumphs and failures in the lab as they attempt to make medical history at a landmark clinical trial in 2015. More than 90 years after the discovery of insulin, ViaCyte has received FDA approval to launch the first ever-human trial of a stem-cell derived treatment that might cure type 1 diabetes. ViaCyte’s trial is only the third ever in the US, and the sixth ever in the world to use embryonic stem cell therapy to cure a disease. Only a decade ago America was torn apart by a political and religious debate about the ethics of using human embryos for stem cell research. Now, The Human Trial is filming the first six months of the first phase of the trial, to document every step of this remarkable moment in medical science. One donated human embryo might be the cure for millions of people suffering from diabetes. But, more than that, the film provides context for what it took to get here: the years of research, by scores of scientists working in other facilities around the world; and the extraordinary costs of getting a new drug to market — on average, $2.9 billion, according to Forbes magazine. Already four years in production, The Human Trial brings to life the human realities of diabetes, which causes a death every seven seconds and will be the leading cause of death in the US by 2030. With exclusive access to the patients who are the subjects of Phase I/II of the trial, the film illuminates the emotional, physical and financial costs of diabetes that is a $612 billion health expenditure worldwide. It’s a rare opportunity to capture how science, commerce and politics intersect, a Continue reading >>
Viacyte Announces First Patients Implanted In Cohort 2 With Potentially Efficacious Dose Of Pec-direct Islet Cell Replacement Therapy
ViaCyte Announces First Patients Implanted in Cohort 2 with Potentially Efficacious Dose of PEC-Direct Islet Cell Replacement Therapy President and CEO Dr. Paul Laikind will give an update at Biotech Showcase in San Francisco SAN DIEGO, Jan. 5, 2018 /PRNewswire/ -- ViaCyte, Inc. , a privately-held regenerative medicine company, today announced that the first patients have been implanted in Cohort 2 with a potentially efficacious dose of the company's PEC-Direct islet cell replacement therapy. This novel cell replacement therapy is being developed as a potential functional cure for patients with type 1 diabetes who are at high risk for acute life-threatening complications. Paul Laikind, Ph.D., President and CEO of ViaCyte, will give an update at the 10th Annual Biotech Showcase Conference, on Monday, January 8 at 11:15 a.m. in Franciscan C at the Hilton San Francisco Union Square. The PEC-Direct product candidate is currently in a Phase 1/2 open-label clinical trial at multiple sites in the United States and Canada to evaluate safety and efficacy. Cohort 2 is expected to enroll up to 40 patients, and the primary efficacy measurement will be the clinically relevant production of insulin, as measured by the insulin biomarker C-peptide, in a patient population that has little to no ability to produce endogenous insulin at the time of enrollment. Other important endpoints will be evaluated including injectable insulin usage and the incidence of hypoglycemic events. "The implantation of a potentially efficacious dose of PEC-Direct marks an important milestone in the development of a functional cure for diabetes," said Dr. Laikind. "While we are developing PEC-Direct to meet a critical unmet medical need for people who are most severely impacted by type 1 diabetes, we are als Continue reading >>
Viacyte | The Stem Cellar
The Official Blog of CIRM, California's Stem Cell Agency This week, multiple CIRM-funded studies appeared in the news, highlighting the exciting progress our Agency is making towards funding innovative stem cell research and promoting the development of promising stem cell therapies for patients. Fate Therapeutics Partners with UC San Diego to Develop Cancer Immunotherapy Last week, Dr. Dan Kaufman and his team at UC San Diego, received a $5.15 million therapeutic translational research award from CIRM to advance the clinical development of a stem cell-derived immunotherapy for acute myelogenous leukemia (AML), a rare form of blood cancer. Today, it was announced that the UCSD team is entering into a research collaboration with a San Diego biopharmaceutical company Fate Therapeutics to develop a related immunotherapy for blood cancers. The therapy consists of immune cells called chimeric antigen receptor-targeted natural killer (CAR NK) cells that can target tumor cells and stop their growth. Fate Therapeutics has developed an induced pluripotent stem cell (iPSC) platform to develop and optimize CAR NK cell therapies targeting various cancers. According to an article by GenBio , this new partnership is already bearing fruit. In preclinical studies using an ovarian cancer xenograft model, Dr. Kaufman and Fate Therapeutics had shown that a single dose of CAR-targeted NK cells derived from iPSCs engineered with the CAR construct significantly inhibited tumor growth and increased survival compared to NK cells containing a CAR construct commonly used for T-cell immunotherapy. City of Hope Brain Cancer Trial Featured as a Key Trial to Watch in 2018 Xconomy posted a series this week forecasting Key Clinical Data to look out for next year . Todays part two of the series mentio Continue reading >>
Stem Cell Implant Trial Aims To Reverse Type 1 Diabetes | Vancouver Sun
The device created by ViaCyte contains millions of cells in packets that are implanted under the skin, in hopes they will function like pancreatic cells. The Human Trial / PNG About 10 British Columbians with Type 1 diabetes will be surgically implanted with packets containing lab-grown cells that are coaxed into behaving like true insulin-producing pancreatic cells in hopes of reversing their disease. The first patient to receive the implants is keen to exchange his regime of daily pinprick blood tests and insulin injections for a handful of pills for immune suppression. My blood sugar can go down all day without my noticing, so Im always at risk for passing out among other health problems, said Joshua Robertson. The risks of immune suppression (medication) are well known and its no comparison. Joshua Robertson is a participant in a trial of a new treatment for Type 1 diabetes created by ViaCyte.UBC / PNG The trial follows a procedure that successfully cured mice with diabetes, pioneered byTimothy Kieffer at the University of B.C. After receiving implants of millions of stem cells, the mice were weaned from insulin over the course of several months. Lead investigator, UBC endocrinologist David Thompson called the new treatment the most promising he has ever worked on. If the goal is to allow people to stop taking insulin, this trial has the potential to do it, he said. Robertson was implanted last month with several packets smaller than a credit card each containing millions of immature pancreatic cells, grown from embryonic stem cells using a technique developed by the San Diego biotech firm ViaCyte. UBC and Vancouver Coastal Health are running the two-year trial supported by a $500,000 grant from Stem Cell Network of Canada. If the cells multiply and develop as hope Continue reading >>
