INTRODUCTION:

Mellitus means sweet, and diabetes implies a passer-by a syphon.¹Diabetes mellitus is a group of insulin resistance syndrome characterized by a high sugar level over a prolonged period of time² Diabetes mellitus is a long-term metabolic disease involving the proteins, lipids, and carbs. One of the hallmarks of diabetes mellitus is a poor or insufficient insulin secretory response. Which results in impaired utilization of carbohydrates (glucose). Another characteristic is the hyperglycemias that follow. Diabetes mellitus (DM) is the most common endocrine illness and is sometimes referred to as a “sugar”. It is referred to as diabetes or sugar illness in the community² It is an illness that is not contagious. The group of insulin resistance syndrome over an extended length of time is called Diabetes mellitus (DM). Hyperglycemia is one of its hallmarks.⁴

Figure 1: Classification of Diabetes Mellitus

Classification of Diabetes Mellitus:

Type 1 Insulin-dependent diabetes mellitus (TIDDM):

Formally known as juvenile onset Diabetes, this form of diabetes is now called auto immune diabetes.⁶Another Name for it is ketosis prone polygenic illness. This develops before the age of forty and mostly affects children.^6,7 This illness strikes teenagers out of nowhere and has the potential to be fatal. Insulin can be used to manage or treat type 1Diabetes, but there is no known cure.³ Insulin is necessary for people with Type 1 diabetes. Because of the loss of ẞ cells, TIDM causes the pancreas to be Unable to produce enough insulin⁸ About 10% Suffers from T1DM⁹

Type 2 Insulin-Independent Diabetic Mellitus (TIIDM): Another name for T2NIIDM is adult-onset diabetes Mellitus. Insulin resistance is influenced by insulin secretion abnormalities found in type 2 diabetes.⁶ This Condition was once referred to as non-insulin dependent diabetes mellitus. The illness progresses gradually over time. A disorder where cells become resistant to the effects of insulin due to high blood sugar and free fatty acids levels. It results from beta cell abnormalities brought by the bloodstream’s built-in glucose and insulin resistance⁷

Gestational Diabetes Mellitus:

It is the most prevalent kind of infectious monogenic illness. Women who have had class A2 require insulin, as well as additional medications. Pregnant women without a history of diabetes mellitus can develop gestational diabetes. GDM is typically identified in the latter stages of pregnancy and frequently affects people who have never had diabetes mellitus before. A newborn with diabetes mellitus has an increased risk of obesity and type 2 diabetes in the future^6,7

Another kind of DM

It is sometimes referred to as monogenic type.

It includes Endocrinopathy, LADA, and MODY.

MODY, or maturity onset diabetes of the young,

These are caused by genetic abnormalities in the internal secretion of the insulin hormone.^10,11

Structure and composition of pancreatic islet cells:

The pancreas is a complex Organ with both endocrine and exocrine functions. The adult endocrine pancreas, islets of Langerhans, constitutes about1-4% of the total pancreas¹³. In Normal human Pancreas is responsible for production of different kinds of hormones Pancreas is made up of around 95% exocrine tissue and 5% endocrine tissue, which is Made up of thousands of islets of Langerhans, which are endocrine cells.¹² These Endocrine tissues secrete substances directly in the bloodstream. These are Structurally similar to clusters of grape-like cells that secrete a key hormone that Controls blood sugar and pancreas secretion. There are hormone-producing cells inside Every islet cell. These cells are called α, β, Γ, and δ cells. That α cells releases glucagon β Cells release insulin, and Γ, cells release pancreatic polypeptide Somatostatin is Released and synthesized by δ cells.¹⁴ Pancreatic islets receive upto 20% of total pancreatic blood supply due to this it is considered as highly vascularized micro-organs¹⁵ The process of pancreatic islet vascularization Leads to the detection of blood glucose levels, which are necessary for the appropriate Execution of islet endocrine function and the effective delivery of hormones to target Tissue. According to studies, islets are highly organized micro-organ belonging to a Species, not just unorganized clusters of endocrine cells. Particular Three-Dimensional structure Pancreatic islet can efficiently carry out its functions Because of the cellular organization. Because the human islet is made up of Several cell types, its architecture is more complex than other islets.^16,17Approximately 30% of human islets are α-cells, which produce glucagon, approximately 60% are β-cells, and the remaining approximately 10% are Composed of δ-cells, which produce somatostatin, γ-o PP cells, which produce Pancreatic polypeptide, and ε-cells, which produce ghrelin. The diameter Range of human islets is around 50-500µm, and there is an average variance Of 1500 in the ratio of endocrine cells among individuals, which is reflected in Differences in βcells.¹⁸

Figure 2: Structure of Pancreatic islet cells

Autocrine and paracrine function of pancreatic βcells: Endocrine cells within the pancreatic islets secrete a wide range of diffusible chemical messengers, the autocrine or paracrine factors, which via binding to cognate receptors, are able to evoke biological effects in the neighbouring cells. Experimental studies have shown that by synchronizing their secretory activity in response to electrical coupling, autocrine or paracrine signaling, islet β-cells exploit several pathways of cell-to-cell communication¹⁹. However, human β-cells show complex and heterogeneous electro-physiological responses to many factors including ion channel antagonists²⁰. This is probably due to the variability in the number of specific channels between β-cells that has been modelled to generate variable oscillation patterns and responses thus affecting the regularity of membrane potential bursting and [Ca2+] oscillations^21-23. The release of glucagon from α-cells triggers human β-cell G protein-coupled receptors (GPCR), such as glucagon receptor (GCGR), one of the paracrine mediators of β-cells., and glucagon-like peptide 1 receptor (GLP-1R)^24-25. Both glucagon and GLP-1 increase intracellular camp levels and elicit synchronous intracellular Ca2+oscillation respectively in human β-cell^26-27. By utilizing optogenetics, based on the signature of Ca2+ dynamics, discrete functional subpopulations of β-cells have been identified²⁷. Therefore, it is likely that these subpopulations of β-cells will show functional heterogeneity in controlling coordinated electrical regulation and electrical dynamics in response to paracrine actions of glucagon or GLP-1^13,28

Different Therapies Used in Diabetes:

Insulin Therapy: Insulin Treatment Insulin therapy is necessary for people with TIDM. Controlling or maintaining blood sugar levels is the aim of insulin therapy. It is administered subcutaneously with the aid of an insulin peno insulin pump and syringe. The most crucial treatment for TIDM and occasionally for T2DM is insulin therapy. Your doctor will discuss three important points while discussing insulin³

1. Onset

2. The peak time

3. Duration

Islet Replacement Therapy:

Traditionally, diabetes mellitus cannot be properly cured in vitro, despite insulin infusions. An alternate treatment option for individuals with diabetes is islet replacement therapy. This treatment involves transplanting pancreatic islet cells to replace the beta cells that produce insulin. It is occasionally used due to its poor success rate. Rather, there are other obstacles to this significant switch from conventional/traditional insulin to islet transplants, including a shortage of donors, the need for islet grafts to operate well, long-term survival, etc.²⁸

Transplantation of pancreatic islet cell: The history of solid organ Transplantation has been more difficult. Developments in pancreas and beta Cell transplantation have been inspired by the discovery of a link between Pancreatic islet beta cell loss and type 1 diabetes²⁸.

What is pancreatic islet transplantation?

Transplantation of pancreatic islet cells can decrease the amount of hypoglycemia episodes that go unrecognized and are resistant to treatment. The purpose of allogeneic islet transplantation is to engraft pancreatic islets into recipients with insulin-deficient diabetes, most commonly type 1 patients, in order to restore normal insulin, glucagon, and other islet-hormone secretion.²⁹

Since the 1980s, pancreatic islet cell transplantation has been effective in a small number of patients with type 1 diabetes.²⁹ Transplantation of pancreatic islets alone to restore b cell mass, however, had limited success until the development of the Edmonton Protocol in 2000, which demonstrated that infusion of islets into the liver via the portal vein was sufficient to restore glucose homeostasis.³⁰

Islet replacement therapy: Treatment for type 1 diabetes may involve β-cell mass replacement treatment. decades of donor islet transplant, gives information about the ability of βcells to engraft and function upon transplant. Now transplantation of pancreatic islet can be considered as therapeutic option in several conditions associated with loss of β-cell function.³²

Sources for islet cell transplantation: Main source of islet transplantation can be patients own pancreas (autologous and auto transplant) mainly when there is surgical removal of the gland due to different condition.³²

Indication for Allogenic islet cell transplantation:

The main indication for allogenic islet cell transplantation is T1D which is characterized by selective destruction of β cell due to auto immune process. islet transplantation also indicated for the cases of subcutaneous insulin resistance requiring intraperitoneal or intravenous infusion which are associated with substantial management hurdles and morbidity. This implies that the use of exogeneous insulin or other antidiabetic drugs after islet transplantation is not synonymous of graft loss or failure if there is impairment in hypoglycemia Awareness frequent occurrence of severe glycemia or marked glycemic variance³¹

Implementation site: The implementation site for islet transplantation is usually hepatic parenchyma through the portal system of the recipient³⁴. There are some other implementation sites have been proposed in clinical setting like the Bone marrow,^35,36 the subcutaneous site³⁷ the gastric submucosa,³⁸the omentum³⁹. this may be proving as valid site for transplantation.

Objective: There are various objectives of islet cell transplantation. The main objective of transplant is to correct the high susceptibility towards severe hypoglycemia.³³ It also helps in managing glucose imbalance that are associated with high mortality and achieve good overall blood sugar control with little and no insulin injection. The achievement of some degree of insulin independence is one of the primary objectives of islet cell transplantation. The rate of insulin independence varies widely among centers, 20 to 90%.⁴⁰

Lantidra: Lantidra is first allogenic islet cell therapy. On June 28, 2023, the FDA Centre for biologics Evaluation and research (CBER) approves lantidra for type 1 diabetes Patients⁴² who are able to approach target glycated hemoglobin because of Recurrent, severe hypoglycemic episodes despite receiving comprehensive Diabetes care and education, allogenic pancreatic islet therapy is appropriate⁴³. Lantidra cell therapy is given as a single infusion into hepatic portal vein, which may be repeated if the initial dose is inadequate.⁴² The therapy is derived from deceased donor pancreatic cells. Lantidra (donislecel), a cell treatment, aids in the functional replacement of pancreatic Islet cells in individuals who are unable to secrete insulin. Donislecel is a Potential treatment for individuals with type 1 diabetes (TID) that introduces Insulin-producing pancreatic islet beta cells from donors, thereby lowering or eliminating the need for external insulin delivery.⁴⁴ It has been developed by the startup Cell Trans and sold under the brand name Lantidra. For Individuals with type 1 diabetes who have severe hypoglycemia, the therapy Has been approved. Adults with T1D who, despite appropriate management of the condition, are unable to achieve the desired glycated hemoglobin (hba1c) can be treated with donislecel.⁴⁵

How lantidra works:

Pancreatic cells from dead donors are used to make lantidra These cells are referred to be Allogeneic islet beta cells, and they are capable of producing and secreting Insulin. The infusion of lantidra facilitates the passage of islet beta cells from the body into the circulation and into the liver through the hepatic portal Vein.⁴⁴ Immunosuppressive drugs are also required to preserve the viability of the transplanted islet cells. Insulin secretion starts as soon as the newly Infused islet beta cells reach the liver. The body can control blood sugar levels Without the need for extra insulin injections or devices if the injected cells Generate enough insulin. Individuals Diagnosed with type 1 diabetes (T1D) are dependent on external insulin Supply. Some people have hypoglycemia unawareness, which is the inability to recognize when blood glucose levels are decreasing. This can lead to both difficulty in obtaining target glucose levels as well as severe hypoglycemia. At This time, Donislecel is specifically only approved for people with type 1Diabetes who experience level 3 hypoglycemia.⁴⁶ “Lantidra is approved for the Treatment of adults with type 1 diabetes who are unable to approach target Glycated hemoglobin (average blood glucose levels) because of current repeated episode.⁴⁹

Pharmacodynamics: Hormones, particularly insulin, secreted by the infused (transplanted) islets in response to variations in blood glucose levels are responsible for the pharmacodynamic effects of lantidra. Using a mixed meal tolerance test (MMTT), baseline and one year after a subject’s previous transplant were measured for both basal and stimulated blood glucose in Studies 1 and 2. When individuals do not require exogenous insulin, the pharmacodynamic profile of the allogeneic islet cells is most clearly displayed.^32,46

The adverse effects of Lantidra: Lantidra often results in nausea, fatigue anemia, diarrhea, and stomach discomfort as adverse effects. Serious adverse effects occurred in some of the individuals, and they were mainly related to the infusion process and the use of immunosuppressive drugs.⁴⁷ When these drugs were discontinued, some people experienced islet cell dysfunction and returned to need external insulin.⁴⁸ “Patient directed labeling” is included with Lantidra so that people with diabetes will understand the possible advantages and disadvantages of treatment.⁵⁰

CONCLUSION:

From the above review we conclude that Diabetes is a non-curable disease, and we get to know about treatment of diabetes and we learned about what is pancreatic islet transplantation. What are its uses, its indication and its objective lantidra is the one of the emerging therapies for type1? Lantidra is allogenic islet cell transplantation. Diabetes Patients who are unable to approach target glycated hemoglobin because of Recurrent, severe hypoglycemic episodes despite receiving comprehensive Diabetes care and education, allogenic pancreatic islet therapy is appropriate. Allogeneic pancreatic islet beta cell transplantation is currently a viable treatment option due to the rising prevalence of type 1 diabetes worldwide. While early data from clinical trials is beneficial, there are still issues that need to be resolved, such as improving cell harvesting and preservation techniques and refining immune suppression regimens after transplantation.

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Received on 29.04.2024 Modified on 03.06.2024

Asian J. Pharm. Res. 2024; 14(3):331-335.

DOI: 10.52711/2231-5691.2024.00052

Lantidra: Cell Therapy for Treatment of Type 1 Diabetes Mellitus