Transplanted Pancreatic Cells: A Breakthrough in the Treatment of Difficult-to-Control Type 1 Diabetes
Introduction
In recent years, the treatment options for individuals with difficult-to-control type 1 diabetes have been expanding and progressing. Transplanting pancreatic cells has emerged as a promising approach to provide relief for those who struggle with low blood sugar (hypoglycemia) and may not experience the typical symptoms. This article delves into the latest advancements in this field, focusing on two developments in particular. It explores the recent approval of Lantidra, a therapy made from pancreatic islet cells, and the promising results from the clinical trial of VX-880, a type of pancreatic islet cell made from stem cells.
Understanding the Challenges of Type 1 Diabetes
Before diving into the breakthrough treatments, it is essential to comprehend the challenges faced by individuals with type 1 diabetes. This autoimmune disease targets the insulin-producing pancreatic beta cells, leading to a reliance on insulin injections or pumps for survival. Regular monitoring of blood sugar levels and adjustments to insulin dosages are also necessary. However, some people with type 1 diabetes experience hypoglycemia without noticeable symptoms, making them suitable candidates for islet cell therapy. Immunosuppressant drugs are currently required for this treatment, posing additional risks and complications. Researchers are diligently working towards eliminating the need for these drugs to provide a safer solution.
Lantidra: An Approved Breakthrough
The FDA’s recent approval of Lantidra marks a significant milestone in the treatment of difficult-to-control type 1 diabetes. Lantidra is derived from pancreatic islet cells obtained from deceased donors who had willingly agreed to have their organs donated after their passing. Manufactured by CellTrans, this therapy has been specifically approved for individuals with type 1 diabetes who struggle to achieve target blood sugar levels through insulin usage alone.
In clinical trials, Lantidra showcased promising results. Out of 30 patients involved, 21 individuals did not require any insulin for at least one year, and 10 of them remained insulin independent for more than five years after the treatment. However, it is essential to note that it did not prove effective in five patients. Side effects of Lantidra included nausea, fatigue, anemia, and abdominal pain. Furthermore, a vast majority of participants experienced at least one serious adverse reaction due to the intravenous procedure in the portal vein or the immunosuppressive drugs. These adverse events should be carefully considered when evaluating the benefits and risks of Lantidra for each patient.
VX-880: Promising Results with Stem Cell-Derived Islets
A different approach to obtaining pancreatic islet cells involves utilizing stem cells. Vertex Pharmaceuticals’ VX-880 is a type of pancreatic islet cell derived from stem cells, and it has shown remarkable outcomes in its initial clinical trial. The trial included two individuals with type 1 diabetes and severe hypoglycemia who were able to completely eliminate their reliance on insulin for at least one year. Additionally, three more participants in this trial are moving towards that outcome. These findings were presented at the American Diabetes Association’s annual scientific sessions, garnering significant interest and hope.
What sets VX-880 apart is its potential to overcome the hurdles that have hindered pancreatic islet transplantation thus far. The limited supply of islets for transplantation has been an obstacle, but the ability to grow stem cell-derived islets in the laboratory opens up the possibility of an almost limitless supply. Moreover, VX-880 has shown no major safety concerns in the initial trial. Therefore, its testing is being expanded in multiple European countries, as well as the United States. If successful, VX-880 could revolutionize the treatment of difficult-to-control type 1 diabetes.
The Potential of Pancreatic Islet Transplantation
Pancreatic islet transplantation has long held promise as a treatment for individuals with the most challenging-to-manage type 1 diabetes, especially those who experience frequent and severe hypoglycemia. However, two significant obstacles have hindered progress in this field. The first challenge lies in the insufficient supply of islets available for transplantation. The second obstacle involves the toxicity associated with immunosuppressive drugs required to prevent rejection of the transplanted islets.
Researchers believe that the results achieved with VX-880 hold the key to overcoming these hurdles. By cultivating stem cell-derived islets in the laboratory, the supply of islets becomes virtually unlimited. This breakthrough offers immense hope to individuals struggling with difficult-to-control type 1 diabetes. It also aligns with the ongoing efforts of medical professionals to establish safer and more effective treatments for the condition.
Conclusion
The treatment of difficult-to-control type 1 diabetes is making significant strides with the advancement of transplanted pancreatic cells. The FDA’s approval of Lantidra and the promising outcomes of the clinical trial for VX-880 highlight the potential of this approach in improving the lives of those grappling with the challenges of type 1 diabetes. While Lantidra addresses the need for improved blood sugar control, VX-880 offers the possibility of eliminating the dependence on insulin altogether. These breakthroughs bring hope and excitement to the medical community and individuals living with difficult-to-control type 1 diabetes.
Summary
Treatment of difficult-to-control type 1 diabetes is progressing on multiple fronts, with recent approvals and advances in clinical trials for transplanted pancreatic cells. By utilizing pancreatic islet cells from deceased organ donors, therapies like Lantidra have been approved by the FDA for people who cannot achieve target blood sugar levels using insulin alone. Clinical trials have shown impressive results, with a significant number of patients not requiring insulin for extended periods after the treatment.
On another front, VX-880, a type of pancreatic islet cell derived from stem cells, has shown promise in an initial clinical trial. Multiple participants were able to eliminate their reliance on insulin for at least one year, and further trials are underway to increase the scope and efficacy of this treatment.
The breakthroughs achieved with Lantidra and VX-880 offer renewed hope for individuals with difficult-to-control type 1 diabetes. These advancements pave the way for improved blood sugar control and the potential to eliminate the need for insulin altogether. With ongoing research and development in this field, the prospects for a safer and more effective treatment for type 1 diabetes are brighter than ever before.
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June 30, 2023 – Treatment of difficult-to-control type 1 diabetes with transplanted pancreatic cells is progressing on two fronts, with one product recently approved and the other advancing in a clinical trial.
Type 1 diabetes is an autoimmune disease in which insulin-producing pancreatic beta cells (often called simply “islets” because they reside in the islets of Langerhans, part of the pancreas) are destroyed by the body’s own immune reactions. People with the condition take insulin through injections or a pump to stay alive and must also regularly check their blood sugar levels and adjust their insulin.
But some people with type 1 diabetes often have low blood sugar (hypoglycemia) and may not feel the symptoms, such as shaking and sweating, that indicate a drop in blood sugar. Such people (known as hypoglycemic unawares) are the only candidates for islet cell therapy, in part because they must also take drugs to suppress their immune systems to prevent rejection, just as is required for any other organ transplant. , like a kidney, and that also brings risks. Researchers are working to end the need for immunosuppressants.
The FDA on Wednesday approved Lantidra, a therapy made from pancreatic islet cells from deceased donors who, or whose families, agreed to donate their organs after their deaths. Lantidra, made by CellTrans, is approved for people with type 1 diabetes who cannot reach target blood sugar levels using insulin.
In clinical trials with Lantidra, 21 of 30 patients did not require insulin for at least 1 year, while 10 remained insulin independent more than 5 years after treatment. But in five patients, it didn’t work at all.
Meanwhile, in an initial clinical trial of a different type of pancreatic islet cell made from stem cells, Vertex Pharmaceuticals’ VX-880, two people with type 1 diabetes and severe hypoglycemia were able to come off insulin completely for at least one year. and three others are moving in that direction. Those findings were presented June 23 at the American Diabetes Association’s annual scientific sessions.
Both types of islets infuse into the portal vein, which carries blood from various organs to the liver, as well as insulin from the pancreas to the liver in people without type 1 diabetes.
“For decades, the promise of pancreatic islet transplantation as a treatment for a small subset of people with the most difficult-to-manage type 1 diabetes, and particularly those with frequent and severe hypoglycemia, has faced two major obstacles,” he said. David. M. Harlan, MD, co-director of the University of Massachusetts Diabetes Center of Excellence.
“One is an insufficient supply of islets to transplant, and two, the sometimes toxic immunosuppression needed to prevent immunological rejection of the transplanted islets,” he said.
The recent results using VX-880 “hold the promise of overcoming both hurdles in that stem cell-derived islets can be grown in the laboratory, opening up the possibility of a virtually unlimited supply,” Harlan said. , who is also a professor of medicine. at the University of Massachusetts Chan School of Medicine in Worcester.
There were no major safety concerns in the VX-880 study, which is now being expanded to include more people in several European countries, as well as the United States.
With Lantidra, side effects included nausea, fatigue, anemia, and abdominal pain. Most people in the trial had at least one serious adverse reaction, due to the intravenous procedure in the portal vein or immunosuppressive drugs. In some cases, these events required the person to stop using those drugs and lose the function of the transplanted cells.
“These adverse events should be taken into account when evaluating the benefits and risks of Lantidra for each patient,” the FDA said in a statement.
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