ABSTRACT:
The more recent cell treatment for type 1 Diabetes is called lantidra. Lantidra has recently received approval to treat type 1 Diabetes mellitus. The first allogeneic (deceased donor) pancreatic islet cell therapy, lantidra (donislecel), was approved by the FDA Centre for Biologics Evaluation and Research (CBER) on June 28, 2023. It is intended to treat adults with type 1 diabetes who, despite current management, do not achieve target glycosylated hemoglobin levels due to recurrent episodes of severe hypoglycemia. The editorial’s goal is to draw attention to the growing impact of type 1 diabetes on the world’s health, discuss earlier attempts at pancreatic transplant techniques, and announces the first regulatory approval of a revolutionary transplant strategy called allogeneic pancreatic islet beta cell infusion.
Cite this article:
Shital B. Bharambe, Shailesh Jawarkar. Lantidra: Cell Therapy for Treatment of Type 1 Diabetes Mellitus. Asian Journal of Pharmaceutical Research. 2024; 14(3):331-5. doi: 10.52711/2231-5691.2024.00052
Cite(Electronic):
Shital B. Bharambe, Shailesh Jawarkar. Lantidra: Cell Therapy for Treatment of Type 1 Diabetes Mellitus. Asian Journal of Pharmaceutical Research. 2024; 14(3):331-5. doi: 10.52711/2231-5691.2024.00052 Available on: https://asianjpr.com/AbstractView.aspx?PID=2024-14-3-21
REFERENCES:
1. M N Piero, G M Nzaro, and J M Njagi. Diabetes mellitus – A devastating metabolic disorder. Asian Journal of Biomedical and Pharmaceutical Sciences, pages 1–7: 2014. DOI: 10.15272/ajbps. v4i40.645
2. S Alam, E Khalid, I Patel, I Mulla, S Ansari, and B Ayesha. The history of diabetes: From olden Days to discovering Insulin. International Journal of Unani and Integrative Medicine. 2017; 1(1): 25–28.
3. Afroj A. Shaikh Mayur K. Kolhatkar, Dipak R. Sopane, Ashish N. Thorve Review on: Diabetes Mellitus is a Disease. International Journal of Research in Pharmaceutical Sciences 2022; 13(1): 102-109 https://doi.org/10.26452/ijrps.v13i1.27
4. Josephine M. Forbes, and Mark E. Cooper. Mechanisms of Diabetic Complications Published Online: 2013 JAN https://doi.org/10.1152/ physrev.00045.2011
5. Carolina Solis. Herrera, MD Curtis, Triplitt. Charles Reasner Ralph. A. Defronzo. Classification of diabetes mellitus
6. WHO? Definition, Diagnosis and Classification of Diabetes Mellitus and its Complications: Report of a WHO consultation. World Health Organization, pages 1–59, 1985. Part 1, Document number WHO/NCD/NCS/99.2
7. R Kumar, P Saha, Y Kumar, S Sahana, A Dubey, and O Prakash. A Review on Diabetes Mellitus: Type1 and Type2. World Journal of Pharmacy and Pharmaceutical Sciences. 2020; 9(10): 838–850.
8. Classification and diagnosis of Diabetes. American Diabetes Association. Diabetes Care. 2016; 39 (Sulp-1): 13-22.
9. Diabetes, Diabetes types, Risk factors, test, treatment and prevention. Clevel and Clinic. 2021
10. A Jones and A Hattersley. Monogenic cause of diabetes. Textbook of Diabetes. 2010: 243-264.
11. Chaudhary, N.., and Tyagi, N. Diabetes mellitus: An Overview. International Journal of Research and Development in Pharmacy & Life Sciences. 2018; 7(4): 3030- 3033. https://doi.org/10.21276/ IJRDPL.2278-0238.2018.7(4).3030-3033
12. Pancreas function and disorder. https://www.medicalnewstoday.com/ articles/10011#function
13. Noura Aldous. Abu Saleh Md Moin Essam M. Abdelalim. Pancreatic β‑cell heterogeneity in adult human islets and stem Cell‑derived islets. Cellular and Molecular Life Sciences. 2023; 80:176. https://doi.org/ 10.1007/s00018-023-04815-7
14. Dolenšek J, Rupnik MS, Stožer A. Structural similarities and differences between the human and the mouse pancreas. Islets. 2015; 7(1): e1024405–e1024405. https://doi.org/10.1080/ 19382014.2015.1024405
15. Rorsman P, Ashcroft FM. Pancreatic β-cell electrical Activity and insulin secretion: of mice and men. Physiol Rev. 2018; 98(1): 117–214. https://doi.org/10.1152/physrev.00008.2017
16. Cabrera O, Berman DM, Kenyon NS, Ricordi C, Berggren PO, Caicedo A. The unique cytoarchitecture of human pancreatic islets has implications for islet cell function. Proc Natl Acad Sci. 2006; 103: 2334–2339
17. Wierup N, Sundler F. Ultrastructure of islet ghrelin cells in the human fetus. Cell Tissue Res. 2005; 319(3): 423–428. https://doi.Org/ 10.1007/s00441-004-1044-x
18. Gabriela Da Silva Xavier. The Cells of the Islets of Langerhans. J Clin Med. 2018 Mar; 7(3): 54.doi: 10.3390/jcm7030054
19. Cherubini C, Filippi S, Gizzi A, Loppini A. Role of topology in complex functional networks of beta cells. Phys Rev E Stat Nonlin Soft Matter Phys. 2015; 92(4): 042702. https://doi.org/ 10.1103/ PhysRevE.92.042702
20. Andrean D, Pedersen MG. Machine learning provides insight into models of heterogeneous electrical activity in human beta-cells. Math Biosci. 2022; 354:108927. https://doi.org/10.1016/ j.mbs.2022.108927
21. Sherman A, Rinzel J, Keizer J. Emergence of organized bursting in clusters of pancreatic beta-cells by channel sharing. Biophys J. 1988; 54(3): 411–425. https://doi.org/10.1016/ s00063495(88)82975-8
22. Jo J, Kang H, Choi MY, Koh DS. How noise and coupling induce bursting action potentials in pancreatic {beta}-cells. Biophys J. 2005; 89(3): 1534–1542. https://doi.org/10.1529/ biophysj.104053181
23. Zhang M, Goforth P, Bertram R, Sherman A, Satin L (2003) The Ca2+ dynamics of isolated mouse beta-cells and islets: implications for mathematical models. Biophys J 84(5): 2852–2870. https://doi.org/10.1016/s0006-3495(03)70014-9
24. Rodriguez-Diaz R, Molano RD, Weitz JR, Abdulreda MH, Berman DM, Leibiger B, Leibiger IB, Kenyon NS, Ricordi C, Pileggi A, Caicedo A, Berggren PO. Paracrine interactions within the pancreatic islet determine the glycemic set point. Cell Metab. 2018; 27(3): 549-558.e544. https://doi.org/10.1016/ j.cmet.2018.01.015
25. Capozzi ME, Svendsen B, Encisco SE, Lewandowski SL, Martin MD, Lin H, Jafe JL, Coch RW, Haldeman JM, MacDonald PE, Merrins MJ, D’Alessio DA, Campbell JE (2019) β Cell tone is defined by proglucagon peptides through cAMP signaling. JCI Insight. https://doi.org/10.1172/jci.insight.126742
26. Marchetti P, Lupi R, Bugliani M, Kirkpatrick CL, Sebastiani G, Grieco FA, Del Guerra S, D’Aleo V, Piro S, Marselli L, Boggi U, Filipponi F, Tinti L, Salvini L, Wollheim CB, Purrello F, Dotta F. A local glucagon-like peptide 1 (GLP-1) system in human pancreatic islets. Diabetologia. 2012; 55(12): 3262–3272. https://doi.org/ 10.1007/s00125-012-2716-9
27. Westacott MJ, Ludin NWF, Benninger RKP. Spatially organized beta-cell subpopulations control electrical dynamics across islets of langerhans. Biophys J. 2017; 113(5): 1093–1108. https://doi.org/10.1016/ j.bpj.2017.07.021
28. Jean-Claude Henquin. Paracrine and autocrine control of insulin secretion in human islets: evidence and pending questions. American Journal of Physiology-Endocrinology and Advances in Metabolism 14 JAN 2021. https://doi.org/10.1152/ ajpendo.00485.2020
29. Marie-Christine Vantyghem, Eelco J P de Koning, François Pattou, and Michael R Rickels. β-cell replacement therapy for the treatment of type 1 diabetes, Lancet. 2019; 394(10205): 1274–1285. doi: 10.1016/S0140-6736(19)31334-0.
30. Nathaniel J. Hogrebe, Matthew Ishahak, and Jeffrey R. Millman Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes Stem Cell 30, May 4, 2023. https:// doi.org/10.1016/j.stem.2023.04.002
31. Valeria Sordia, Laura Monacoa, Lorenzo Piemontia, Cell Therapy for Type 1 Diabetes: From Islet Transplantation to Stem Cells Horm Res Paediatr. 2023; 96: 658–669. DOI: 10.1159/000526618
32. Piemonti L. Islet transplantation. Endotext. South Dartmouth, MA: mdtext.com, Inc. 2019.
33. Piemonti L. Felix dies natalis, insulin. Ceterum autem censeo “beta is better”. Acta Diabetol. 2021; 58(10): 1287–306.
34. Cantarelli E, Piemonti L. Alternative transplantation sites for pancreatic islet grafts. Curr Diab Rep. 2011; 11(5): 364–374.
35. Maffi P, Balzano G, Ponzoni M, Nano R, Sordi V, Melzi R, Mercalli A, Scavini M, Esposito A, Peccatori J, Cantarelli E, Messina C, Bernardi M, Del Maschio A, Staudacher C, Doglioni C, Ciceri F, Secchi A, Piemonti L. Autologous pancreatic islet transplantation in human bone marrow. Diabetes. 2013; 62(10): 3523–3531.
36. Maffi P, Nano R, Monti P, Melzi R, Sordi V, Mercalli A, Pellegrini S, Ponzoni M, Peccatori J, Messina C, Nocco A, Cardillo M, Scavini M, Magistretti P, Doglioni C, Ciceri F, Bloem SJ, Roep BO, Secchi A, Piemonti L. Islet Allotransplantation in the Bone Marrow of Patients with Type 1 Diabetes: A Pilot Randomized Trial. Transplantation. 2019; 103(4): 839–851.
37. Yasunami Y, Nakafusa Y, Nitta N, Nakamura M, Goto M, Ono J, Taniguchi M. A Novel Subcutaneous Site of Islet Transplantation Superior to the Liver. Transplantation. 2018; 102(6): 945–952. [PubMed]
38. Wszola M, Berman A, Ostaszewska A, Gorski L, Serwanska-Swietek M, Gozdowska J, Bednarska K, Krajewska M, Lipinska A, Chmura A, Kwiatkowski A. Islets Allotransplantation Into Gastric Submucosa in a Patient with Portal Hypertension: 4-year Follow-up. Transplant Proc. 2018; 50(6): 1910–1913.
39. Bertuzzi F, Colussi G, Lauterio A, De Carlis L. Intramuscular islet allotransplantation in type 1 diabetes mellitus. Eur Rev Med Pharmacol Sci., 2018; 22(6): 1731–1736.
40. What is Islet transplantation. https//WWW.City of hope. com
41. Kevin T. Spence; Danielle E. Ladie. Islets Transplantation StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024
42. FDA approves first cellular therapy to treat patients with type 1 diabetes. Press Release. US Food and Drug Administration. June 28, 2023. Https://www.fda.gov/news-events/press-announcements/ fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes
43. Dinah V. Parums, MD phd. Editorial: First Regulatory Approval for Allogeneic Pancreatic Islet Beta Cell Infusion for Adult Patients with Type 1 Diabetes mellitus sci Monit, 2023; 29: e941918e-ISSN 1643-3750. https://doi.org/10.12659/ MSM.941918
44. Harris E. FDA greenlights first cell therapy for adult with type 1 diabetes. JAMA. 2023 Jul 12. doi :10.1001/jama.2023.12542.
45. Amna Iqbal, Ayesha Sheikh, Donislecel (Lantidra); first stem cell therapy, a Cutting-edge therapeutic option for type 1 diabetes, would it be beneficial in the riskiest region of the world? International Journal of Surgery: Global Health. (2023)6: e0259. https://dx.doi.org/10.1097/ GH.0000000000000259
46. Muhammad Affan Marrium S. Dar Donislecel‑the first approved pancreatic islet cell therapy medication for type 1 diabetes: Irish Journal of Medical Science (1971-) July 2023 https://doi.org/10.1007/ s11845-023-03464-w
47. American Diabetes Association. Hypoglycemia (Low Blood Glucose) | ADA. Diabetes.org. Published 2022. https://diabetes.org/healthy-living/medication-treatments/blood-glucose-testing-andcontrol/ hypoglycemia
48. Bruni A, Bornstein S, Linkermann A, Shapiro AMJ. Regulated Cell Death Seen through the Lens of Islet Transplantation. Cell Transplantation. 2018; 27(6): 890–901. https://doi.org/10.1177/ 0963689718766323.
49. https://www.europeanpharmaceuticalreview.com/news/184114/lantidra-first-cell-therapy-approved-for-type-1-diabetes/
50. Handley G, Hand J.Adverse Effects of Immunosuppression: Infections. Pharmacology of Immunosuppression. 2021: 287–314. https://doi.org/10.1007/164_2021_550