The treatment landscape for Type 1 Diabetes has changed significantly since the US FDA approved Lantidra in June 2023.

Millions of patients worldwide now feel more confident about the ongoing hunt for a cure for Type 1 Diabetes because to this medication. For every 100,000 children aged 0 to 14, there are three new instances of Type 1 diabetes in India.

Comprehending Type 1 Diabetes

Diabetes Type 1 is a chronic autoimmune disease where the immune system of the body targets and kills the beta cells in the pancreas that produce insulin.

The body is consequently unable to manufacture insulin, a hormone that is essential for controlling blood sugar levels.

This results in elevated blood sugar levels, which can have serious side effects such as heart disease, stroke, renal failure, and blindness if unattended.

Type 1 diabetes can cause a number of symptoms, such as ;

• increased thirst,

• frequent urination,

• bedwetting in children who have never wet the bed during the night.,

• extreme hunger,

• involuntary weight loss,

• mood swings,

• irritability,

• weakness,

• blurred vision.

Existing Treatment Possibilities and Barriers

Insulin therapy and nutritional and physical activity changes are part of the current standard treatment for individuals with Type 1 Diabetes.

Insulin therapy works well to control blood sugar levels, but it needs to be used with an insulin pump or daily injections.

Furthermore, the degeneration of beta cells, which is the disease's primary cause, is not addressed by insulin therapy.

The American Diabetes Association states that the glycemic control target of HbA1C, which is <7% in adults and <7.5% in children, is used to diagnose and treat diabetes.

The most widely used treatment option is lifelong insulin, although other non-insulin medications include insulin sensitizers, alpha-glucosidase inhibitors, incretins, pramlintide, bromocriptine, and sodium-glucose cotransporter 2 inhibitors, secretagogues.

Exogenous insulin availability has been shown to extend the life expectancy of those who require it.

In certain circumstances, pancreatic transplantation is also mentioned.

Lantidra: A Revolutionary Approach to Treating Type 1 Diabetes

The US FDA has approved Lantidra, the first allogeneic pancreatic islet cellular therapy, to treat Type 1 Diabetes.

The treatment entails implanting pancreatic islet cells - which contain beta cells that produce insulin - into the patient's body from a healthy donor.

The body's capacity to control blood sugar levels is subsequently restored when the transplanted cells are able to create insulin.

The stages involved in generating drug substances (pre-islet culture) and drug products (post-islet culture) comprise the islet isolation process.

The image above shows a flow diagram of the main processes in the entire manufacturing process.

Islets extracted from a single donor pancreas are used in each Lantidra batch, with each islet destined for a single specified islet recipient.

The donor pancreas is qualified and screened before being accepted; it is regarded as entering raw material.

The Science of Lantidra

Decades of regenerative medicine research served as the foundation for the creation of Lantidra.

To reduce the danger of rejection, the therapy makes use of allogeneic pancreatic islet cells, which are generated from healthy donors and genetically matched to the patient.

The cells are encased in a biocompatible substance that permits nutrients and insulin to pass through while shielding them from the patient's immune system.

Donislecel is administered into the hepatic portal vein using laparoscopic or open surgical access, or through percutaneous or transvenous transhepatic access if these are not practical.

The patient is observed after transplant for safety, immunosuppressive levels, and graft function.

There is no set limit on the number of transplants that patients participating in donislecel clinical studies may get; nevertheless, they may receive up to three transplants.

Scientific Research and Effectiveness

A number of clinical trials including patients with Type 1 Diabetes were used to support the FDA's approval of Lantidra.

An important drop in HbA1c levels, a measure of long-term blood sugar control, and a reduction in the need for insulin therapy were two ways in which the trials proved the medication's safety and effectiveness.

Insulin secretion via infused allogeneic islet beta cells is the principal mode of action of Lantidra, which is administered by a single hepatic portal vein infusion.

The safety and effectiveness of Lantidra were evaluated in 2 nonrandomized, single-arm trials with a total of 30 patients with type 1 diabetes who had 1-3 infusions.

To summarize, 21 individuals did not take insulin for at least a year, 11 did not take it for one to five years, and 10 did not require insulin for more than five years.

But it's important to be aware of possible side effects, such as nausea, lethargy, anemia, diarrhea, and stomach pain.

Loss of islet cell functionality and insulin independence are two more major side effects that might happen with lantidra. 

The Management of Type 1 Diabetes in the Coming Years

By treating the underlying cause, the therapy gives patients a long-term remedy that may lead to a remedy for their illness.

Personalized medicine is made possible by the use of allogeneic pancreatic islet cells, which allow for the customization of therapy to meet the unique needs of each patient.

Because of technological barriers and costs, the benefits of stem cell transplants are not accessible to the general public in many developing nations.

Other difficulties include inadequate transfusion services, a shortage of skilled labor, low socioeconomic status, financial limitations, and difficulties keeping up with technological advancements.

Another issue with lantidra is that, despite a notable rise in demand, stem cell therapies remain incredibly costly to explore.

Stem cell therapy may cost anywhere between $5,000 and $50,000 on average.

With a long-term remedy that targets the disease's underlying cause, the therapy has the power to improve the lives of millions of patients worldwide.

We may anticipate more advancements in the management of Type 1 Diabetes, which will get us one step closer to a cure, as we investigate the possibilities of regenerative medicine.

For those who suffer from severe hypoglycemia, Lantidra provides an option that improves blood glucose management and lowers the risk of injury.

With its approval, people will have more treatment alternatives and be able to reach their desired blood glucose levels.

The approval of Lantidra creates new avenues for the management of diabetes and is a potentially transformative option for individuals who require it.