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The FDA has approved islet cellular therapy for type 1 diabetes for the first time. Image credit: Catherine Falls Commercial/Getty Images
  • In 2021, about 8.4 million people globally had type 1 diabetes.
  • There is currently no cure for type 1 diabetes and those with the condition have to provide their body with missing insulin for their entire life.
  • The Food and Drug Administration (FDA) recently approved a new therapy for type 1 diabetes called Lantidra.
  • Studies show after receiving Lantidra, some study participants did not need to administer insulin for more than 5 years.

As of 2021, about 8.4 million people around the world live with type 1 diabetes — a chronic disease where the pancreas is not able to produce enough insulin for the body to function correctly.

Currently, there is no cure for type 1 diabetes. The main treatment for type 1 diabetes is providing missing insulin through injections or a pump.

Additionally, people with type 1 diabetes may be prescribed additional medications and receive guidelines for healthy lifestyle modifications.

In late June 2023, the Food and Drug Administration (FDA) approved a new therapy for type 1 diabetes called Lantidra — the first allogeneic pancreatic islet cellular therapy made from deceased donor pancreatic cells.

Two safety and efficacy studies found that 21 participants who took Lantidra did not need to administer themselves insulin for a year or more.

Twelve of those participants did not need to take insulin for up to 5 years, and 9 did not need insulin for over 5 years.

Lantidra was developed to assist people with type 1 diabetes who are unable to hit healthy blood sugar levels because of repeated episodes of low blood sugar, despite intensive diabetes management and education.

“A subset of patients with type 1 diabetes cannot control their blood sugars, despite [the] use of [the] best available insulin delivery technology and expert care,” Prof. Jose Oberholzer, ordinarius and chair of the Department of Visceral and Transplant Surgery at the University of Zurich, Switzerland, explained to Medical News Today.

Prof. Oberholzer was a lead researcher on both of the clinical studies behind Latindra, and founder of CellTrans Inc., the company that produces this therapy.

“For those patients, recurrent low blood sugars can make their lives and lead to potentially life-threatening situations. For these patients, an islet cell transplant can offer great [relief] and can be considered life-saving,” he noted.

“In the U.S. alone, there are about 50,000 patients among the 1.5 million patients with type I diabetes that could benefit from this treatment,” the researcher added. “The goal of the BLA approval [Biological License Application] is to provide access to care with islet cell transplantation to those patients in whom the benefits outweigh the known risks.”

Lantidra is an allogeneic (donor) pancreatic islet cellular therapy. In other words, Lantidra uses cells taken — or isolated — from human organ donor pancreases.

“In the process, the donated pancreas is digested in a special chamber using specific enzymes that allow [it] to break the islets out of their natural environment,” Dr. Oberholzer detailed.

“In [a] subsequent process, the insulin-producing islets are purified from the rest of the pancreatic tissue using a density gradient. Once the islets are isolated, purified, and put for a short time in cell culture, the cell preparation is infused into the liver of the recipient,” he explained.

So what actually happens in the bodies of those who receive this form of therapy?

“Broadly, islet cellular therapy is the transplantation of insulin-producing cells into patients [who] do not have functional islet cells of their own,” explained Dr. Zijian Chen, associate professor in the Division of Endocrinology at Mount Sinai Health System, who was not involved in studies related to Lantidra’s approval.

“These cells then replace the function that was lost when the patient developed type 1 diabetes. It is different when compared to conventional insulin therapy, which requires patients to inject themselves with insulin multiple times during the day.”

– Dr. Zijian Chen

Lantidra is administered by an infusion into the body’s portal vein — the big vein that collects blood from the intestines and the pancreas, and channels it to the liver, explained Dr. Christian E. Nasr, clinical professor at the University of Arizona Medical College Phoenix and chief of the Division of Endocrinology at Banner University Medical Group, who also was not involved in studies related to Lantidra’s approval.

“Unlike donor’s bone marrow cells that are able to find their ‘home’ in the recipient’s bone marrow, the islet cells cannot find a home if infused through the peripheral venous system,” he told Medical News Today.

“One creative way of overcoming that has been to infuse these cells through the portal vein and they will nest in the liver where they can survive, obtain blood supply, and respond to ambient glucose by producing appropriate concentrations of insulin to keep the glucose from rising, and therefore leading to insulin independence. Access to the portal vein requires a surgical procedure,” Dr. Nasr noted.

Once engrafted in the recipient, Dr. Oberholzer said, the islets control the blood sugar of the recipient in a fashion very similar to how a healthy pancreas would do this.

“To prevent the rejection of the islets by the host’s immune system, the recipients have to take transplant drugs, similar to organ transplant recipients,” he added.

In order to achieve FDA approval, Dr. Oberholzer and his team conducted clinical trials with accompanying studies starting in 2008 and 2019.

Two non-randomized, single-arm studies with 30 participants were conducted to test Lantidra’s safety and efficacy.

Study participants with type 1 diabetes and low blood sugar unawareness received at least one infusion and a maximum of three infusions.

Upon analysis, researchers found that 21 of the 30 participants were able to stop injecting insulin into their bodies for 1 year or longer.

Of those 21, 12 did not need insulin for 1 to 5 years, and 9 did not need additional insulin for more than 5 years.

Researchers reported side effects associated with Lantidra varied with each study participant depending on how many infusions they received and the length of time they were followed.

The most common adverse reactions reported included nausea, fatigue, anemia, diarrhea, and abdominal pain.

Additionally, researchers reported that the majority (90%) of study participants experienced at least one serious adverse reaction related to the procedure for infusing Lantidra into the portal vein and the use of immunosuppressive medications needed to keep the islet cells working.

“Lantidra in itself is very safe and experience of more than 30 years exists,” Dr. Oberholzer said. “The procedure of applying the cells can be complicated by bleeding from the puncture [site].”

”The main side effects observed in the study patients were related to the immunosuppression needed to prevent rejection,” he noted. ”Those side effects are the same as observed in recipients of organs, such as kidney, liver, and heart transplant patients. These medications require follow-up by an experienced transplant physician or surgeon.”

Dr. Chen told MNT that the approval of Lantidra is an exciting step toward alternative therapies for people living with type 1 diabetes.

“This gives clinicians another option in the management of patients with ‘brittle’ diabetes, a particularly difficult case scenario where patients are at risk for severe hypoglycemia due to conventional treatment,” he pointed out.

“In addition, Lantidra’s approval can lead to future development of ‘cures’ for type 1 diabetes, as well as possible application in patients with type 2 diabetes,” he noted.

Dr. Matthew J. Freeby, assistant clinical professor of medicine, director of the Gonda Diabetes Center, and the associate director of Diabetes Clinical Programs at the David Geffen UCLA School of Medicine, also expressed enthusiasm about the newly approved therapy.

He told us:

“As a provider who treats type 1 diabetes, I welcome the FDA approval for new treatments outside of traditional insulin therapy. Lantidra has the potential to reduce the burden of multiple daily insulin injections and glucose monitoring. It can also eliminate potential risks related to low sugars. For those who it is approved, it may improve quality of life as well as reduce complications related to high and low sugars.“

Yet he also pointed out that the therapy “is not available for all patients with type 1 diabetes due to its side effect profile and need for concomitant immunosuppressant therapy.“

MNT also spoke with Toni Isabella, RN, BSN, CDCES, manager of the MOLLY Diabetes Education Center/Diabetes Team at Hackensack Meridian Health’s Hackensack University Medical Center, who also said her first reaction to hearing about the approval of Lantidra was positive.

“Anything that is well studied and has the potential to make the lives of those living with type 1 diabetes easier to manage and potentially prevent complications is a huge win,” she noted.

However, like Dr. Freeby, Isabella cautioned: “One of the downsides is that the person will have to take anti-rejection medications for the rest of their lives. There are well-known major side effects to these medications which might outweigh the benefits in the long run.”