Cellular therapy for type 1 diabetes is an innovative approach that holds promise in revolutionizing the treatment of this chronic condition. Unlike traditional treatments that focus on managing symptoms, cellular therapy aims to address the root cause of type 1 diabetes by targeting the malfunctioning immune system and regenerating or replacing damaged pancreatic cells responsible for insulin production. This cutting-edge approach represents a potential breakthrough in providing long-term relief and improved quality of life for individuals living with type 1 diabetes. As research and clinical trials in cellular therapy continue to progress, it offers hope for a more effective and transformative treatment option for this autoimmune disease.
As of 2021, approximately 8.4 million individuals worldwide grapple with type 1 diabetes, a chronic condition characterized by inadequate insulin production in the pancreas.(1) At present, there exists no definitive cure for this ailment. The primary approach to managing type 1 diabetes involves the administration of insulin through injections or specialized pumps. Additionally, individuals with type 1 diabetes may receive supplementary medications and guidance for adopting a healthy lifestyle.(2)
In a groundbreaking development, the Food and Drug Administration (FDA) granted approval in late June 2023 for a new therapy known as Lantidra.(3,4) This innovative treatment represents the inaugural allogeneic pancreatic islet cellular therapy derived from pancreatic cells sourced from deceased donors. Intriguingly, two comprehensive studies evaluating its safety and efficacy revealed that out of 21 participants who underwent Lantidra therapy, none required self-administered insulin for a year or more. Impressively, 12 of these participants remained insulin-free for up to five years, while nine managed without insulin for over five years, showcasing the potential of this pioneering treatment.(5)
Read on to find out more about this groundbreaking FDA approval and how cellular therapy for type 1 diabetes can be life changing for many patients.
Everything You Need To Know About Lantidra
Lantidra, a trailblazing therapy developed by CellTrans Inc., is specially crafted for aiding those grappling with type 1 diabetes and facing persistent difficulty in maintaining healthy blood sugar levels. Under the insightful leadership of Professor Jose Oberholzer from the University of Zurich, Switzerland, this innovative solution offers significant relief by making islet cell transplantation accessible.(6)
Despite utilizing state-of-the-art insulin delivery technology and obtaining expert care, a particular subset of patients continually experience perilously low blood sugar levels. Lantidra caters to these individuals, providing them with a potential lifeline to substantially alleviate the pressing challenges posed by uncontrolled blood sugar levels.
Is Lantidra Approved for All Type 1 Diabetics?
Not every individual with type 1 diabetes encounters the same set of problems. For a specific subgroup facing relentless and dangerous fluctuations in blood sugar levels, Lantidra emerges as a crucial intervention.(7)
Through islet cell transplantation, Lantidra stands to be transformative, potentially even life-saving, for approximately 50,000 out of the 1.5 million individuals with type 1 diabetes in the United States. The compelling goal of attaining Biological License Application (BLA) approval is geared towards broadening access to this promising procedure, ensuring the benefits overwhelmingly surpass the known risks for qualified candidates.(8)(9)
Understanding the Mechanism of Islet Cellular Therapy
Islet cellular therapy involves the transplantation of islet cells, which are clusters of cells in the pancreas that produce insulin. In individuals with type 1 diabetes, the immune system mistakenly attacks and destroys these islet cells, leading to a deficiency of insulin production.
During the islet cellular therapy procedure, islet cells are extracted from a donor pancreas. These donor cells are then purified and prepared for transplantation. The purified islet cells are introduced into the recipient’s body, typically through a minimally invasive procedure. Once transplanted, these islet cells settle in the liver, where they can begin producing and releasing insulin.
The goal of islet cellular therapy is to restore the body’s ability to regulate blood sugar levels naturally. By providing a fresh supply of functioning islet cells, the therapy aims to reduce or eliminate the need for external insulin injections and improve overall blood sugar control in individuals with type 1 diabetes.
Lantidra, an allogeneic (donor) pancreatic islet cellular therapy, utilizes cells obtained from human organ donor pancreases. The process involves digesting the donated pancreas in a specialized chamber using specific enzymes to release the insulin-producing islets from their natural environment. Subsequently, the purified islets are separated from the rest of the pancreatic tissue using a density gradient. After a brief period in cell culture, the prepared cells are infused into the recipient’s liver.
Lantidra is administered through an infusion into the body’s portal vein, a large vessel that collects blood from the intestines and pancreas, directing it to the liver.(10) This method ensures the islet cells find their ‘home’ in the liver, where they can survive, receive a blood supply, and respond to glucose levels by producing appropriate amounts of insulin.
Once established in the recipient’s body, the engrafted islets regulate blood sugar in a manner akin to a healthy pancreas. To prevent rejection by the recipient’s immune system, transplant drugs must be taken, similar to other organ transplant recipients.(11) This groundbreaking therapy offers new hope for individuals with type 1 diabetes who struggle to achieve stable blood sugar levels through conventional treatments.
Evidence of Lantidra’s Effectiveness in Type 1 Diabetes Treatment
To validate the effectiveness of the therapy, extensive clinical trials were undertaken by the research team at the University of Zurich, spanning from 2008 to 2019.(12)
These trials consisted of two single-arm studies involving 30 participants. These studies were designed to meticulously evaluate the safety and efficacy of Lantidra. Individuals with type 1 diabetes, experiencing low blood sugar unawareness, received between one to three infusions of the therapy.
The results were compelling. Among the participants, 21 out of 30 were able to discontinue insulin injections for a year or longer. Within this group, 12 individuals remained insulin-free for 1 to 5 years, and 9 individuals maintained this status for over 5 years. This data substantiates the significant potential of Lantidra in revolutionizing type 1 diabetes management.
Are There Any Side Effects of Lantidra?
While Lantidra has shown promise in clinical trials, like any medical treatment, it is not without potential side effects. In the studies conducted, the most commonly reported side effects were generally mild and related to the transplantation procedure. These included symptoms such as abdominal pain, diarrhea, nausea, vomiting, headache, and fever. It is important to note that these side effects are typically associated with the process of islet cell transplantation itself.(13)
Additionally, because Lantidra involves a form of cellular therapy and transplantation, patients receiving it may be at an increased risk of infections. This is primarily due to the use of immunosuppressive drugs, which are administered to prevent the recipient’s immune system from rejecting the transplanted cells. These medications can weaken the body’s natural defense mechanisms against infections. Therefore, patients undergoing this therapy should be closely monitored for any signs of infection, and their healthcare providers will take appropriate measures to manage and address these concerns.
It is noteworthy to mention that a significant majority (90%) of study participants experienced at least one serious adverse reaction related to the infusion procedure and the use of immunosuppressive medications. These medications are essential to prevent the recipient’s immune system from rejecting the transplanted islet cells. The observed side effects are in line with those commonly seen in patients who have undergone organ transplants, like kidney, liver, or heart transplant recipients. Given the potential complexities associated with immunosuppressive drugs, it is crucial for patients to receive ongoing care and follow-up from experienced transplant physicians or surgeons.
Patients considering Lantidra should engage in detailed discussions with their healthcare providers to fully understand the potential benefits, risks, and management strategies associated with the treatment. This personalized approach ensures that the therapy is administered in a manner that aligns with the patient’s specific medical circumstances and needs.
As with any medical intervention, it is crucial for individuals considering Lantidra to have a comprehensive discussion with their healthcare team. This conversation should encompass potential benefits, risks, and any specific considerations based on the patient’s individual health profile and medical history.
The FDA’s approval of Lantidra marks a significant milestone in the treatment landscape for type 1 diabetes. This innovative cellular therapy, derived from deceased donor pancreatic cells, has shown remarkable promise in clinical trials. The ability of Lantidra to provide long-term relief from insulin injections for a substantial portion of participants is a breakthrough that offers hope to individuals struggling with the challenges of type 1 diabetes.
While the therapy has demonstrated notable effectiveness, it’s essential to acknowledge that its use involves careful consideration of individual circumstances and potential side effects. The expertise of experienced transplant physicians and surgeons is crucial in ensuring the safe administration of Lantidra. As further research and real-world applications continue to unfold, this treatment option may revolutionize how type 1 diabetes is managed, offering newfound freedom and improved quality of life for countless individuals living with this chronic condition.
- Gregory, G.A., Robinson, T.I., Linklater, S.E., Wang, F., Colagiuri, S., de Beaufort, C., Donaghue, K.C., Magliano, D.J., Maniam, J., Orchard, T.J. and Rai, P., 2022. Global incidence, prevalence, and mortality of type 1 diabetes in 2021 with projection to 2040: a modelling study. The lancet Diabetes & endocrinology, 10(10), pp.741-760.
- National Institute of Diabetes and Digestive and Kidney Diseases (2019). Insulin, Medicines, & Other Diabetes Treatments | NIDDK. [online] National Institute of Diabetes and Digestive and Kidney Diseases.
- Commissioner, O. of the (2023). FDA Approves First Cellular Therapy to Treat Patients with Type 1 Diabetes. [online] FDA. Available at: https://www.fda.gov/news-events/press-announcements/fda-approves-first-cellular-therapy-treat-patients-type-1-diabetes.
- Research, C. for B.E. and (2023). LANTIDRA. FDA. [online] Available at: https://www.fda.gov/vaccines-blood-biologics/lantidra.
- Hogrebe, N.J., Ishahak, M. and Millman, J.R., 2023. Developments in stem cell-derived islet replacement therapy for treating type 1 diabetes. Cell Stem Cell, 30(5), pp.530-548.
- Prime Therapeutics LLC. (n.d.). CellTrans’ LantidraTM (donislecel) approaches a decision from the FDA.
- Vanstone, M., Rewegan, A., Brundisini, F., Dejean, D. and Giacomini, M., 2015. Patient perspectives on quality of life with uncontrolled type 1 diabetes mellitus: a systematic review and qualitative meta-synthesis. Ontario health technology assessment series, 15(17), p.1.
- Ahmed, K., Muhammad, Z. and Qayum, I., 2009. Prevalence of cutaneous manifestations of diabetes mellitus. J Ayub Med Coll Abbottabad, 21(2), pp.76-9.
- FDA (2019). Biologics License Applications (BLA) Process (CBER). [online] U.S. Food and Drug Administration.
- Carneiro, C., Brito, J., Bilreiro, C., Barros, M., Bahia, C., Santiago, I. and Caseiro-Alves, F., 2019. All about portal vein: a pictorial display to anatomy, variants and physiopathology. Insights into imaging, 10(1), pp.1-18.
- Field, M.J., Lawrence, R.L. and Zwanziger, L., 2000. Immunosuppressive Drugs for Transplant Patients. In Extending Medicare Coverage for Preventive and Other Services. National Academies Press (US).
- clinicaltrials.gov. (n.d.). Islet Transplantation in Type 1 Diabetic Patients Using the University of Illinois at Chicago (UIC) Protocol – Full Text View – ClinicalTrials.gov. [online] Available at: https://classic.clinicaltrials.gov/ct2/show/NCT00679042?term=CellTrans+Inc.&draw=2&rank=2 [Accessed 25 Sep. 2023].
- https://www.facebook.com/Drugscom (n.d.). Lantidra: Uses, Dosage, Side Effects & Warnings. [online] Drugs.com. Available at: https://www.drugs.com/lantidra.html.