FDA approves first cellular therapy for type 1 diabetes

[Aquaman]

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 peopleTrusted Source 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 medicationsTrusted Source and receive guidelines for healthy lifestyle modifications.

In late June 2023, the Food and Drug Administration (FDA) approvedTrusted Source a new therapy for type 1 diabetes called LantidraTrusted Source — the first allogeneic pancreatic islet cellular therapyTrusted Source 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.

 

 

Who is Lantidra for? 

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 approvalTrusted Source [Biological License Application] is to provide access to care with islet cell transplantation to those patients in whom the benefits outweigh the known risks.”

 

 

 

How does islet cellular therapy work?  

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 veinTrusted Source — 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 drugsTrusted Source, similar to organ transplant recipients,” he added.

 

 

How do we know the therapy really works?

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.

 

 

What are the potential side effects of Lantidra? 

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.”

 

A positive step toward more new therapies

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.”

[TrishaManiac]

I have type2 diabetes…. Danni complete ga cure cheyataniki edaina kanipedithe bagunnu 

[csrcsr]

9 minutes ago, TrishaManiac said:

I have type2 diabetes…. Danni complete ga cure cheyataniki edaina kanipedithe bagunnu 

Keto alias veeramachineni alias many low carb diets it will reverse  type 2 , type 1 is different anna

Follow Jason fung videos anna 

[TrishaManiac]

Just now, csrcsr said:

Keto alias veeramachineni alias many low carb diets it will reverse  type 2 , type 1 is different anna

Follow Jason fung videos anna 

right now my diabetes is in control bro after losing weight and following regular medication....but looks like lifelong vaadaali medication....complete reversal anedi not sure if it's going to work for everyone thru veeramach uncle's process

[csrcsr]

Just now, TrishaManiac said:

right now my diabetes is in control bro after losing weight and following regular medication....but looks like lifelong vaadaali medication....complete reversal anedi not sure if it's going to work for everyone thru veeramach uncle's process

It will anna 100% was able to get my brother out of metformin from 1 year but he worked hard lot of control regular exercises regular checks try it anna , medicine will not stop here they keep increasing it 

Watch Jason fung for long create a plan 

Do it undersupervision of your physician

[Aquaman]

Just now, csrcsr said:

It will anna 100% was able to get my brother out of metformin from 1 year but he worked hard lot of control regular exercises regular checks try it anna , medicine will not stop here they keep increasing it 

Watch Jason fung for long create a plan 

Do it undersupervision of your physician

all it does is controlling with healthy diet, medicines and exercise

[Aquaman]

5 minutes ago, TrishaManiac said:

right now my diabetes is in control bro after losing weight and following regular medication....but looks like lifelong vaadaali medication....complete reversal anedi not sure if it's going to work for everyone thru veeramach uncle's process

stem cell therapy research is still under research for Type 2 bro ..... FDA is still looking in to it, one of the risk they saw is getting cancer with cell transplant for type2.. research is still going on.

[csrcsr]

2 minutes ago, Aquaman said:

all it does is controlling with healthy diet, medicines and exercise

No medicine from 18 months he hused to have h1ac around 8 from past year under 5.5 no medicine , other basics like ldl hdl blood pressure all looking good 

[Aquaman]

1 minute ago, csrcsr said:

No medicine from 18 months he hused to have h1ac around 8 from past year under 5.5 no medicine , other basics like ldl hdl blood pressure all looking good 

https://www.webmd.com/diabetes/can-you-reverse-type-2-diabetes

Although there's no cure for type 2 diabetes, studies show it's possible for some people to reverse it. Through diet changes and weight loss, you may be able to reach and hold normal blood sugar levels without medication.

This doesn't mean you're completely cured. Type 2 diabetes is an ongoing disease.

[ranam_007]

Guys there are lot of natural options like veramanchaneni. There is dr ravi varma ayurveda and other options as well

[csrcsr]

3 minutes ago, Aquaman said:

https://www.webmd.com/diabetes/can-you-reverse-type-2-diabetes

Although there's no cure for type 2 diabetes, studies show it's possible for some people to reverse it. Through diet changes and weight loss, you may be able to reach and hold normal blood sugar levels without medication.

This doesn't mean you're completely cured. Type 2 diabetes is an ongoing disease.

Exactly he changed his lifestyle to cut the medicine lot of determination 

[csrcsr]

5 minutes ago, ranam_007 said:

Guys there are lot of natural options like veramanchaneni. There is dr ravi varma ayurveda and other options as well

Not for type 1 anna type 1 is totally different 

[TrishaManiac]

14 minutes ago, csrcsr said:

It will anna 100% was able to get my brother out of metformin from 1 year but he worked hard lot of control regular exercises regular checks try it anna , medicine will not stop here they keep increasing it 

Watch Jason fung for long create a plan 

Do it undersupervision of your physician

 let me do some research

[Aquaman]

33 minutes ago, csrcsr said:

Exactly he changed his lifestyle to cut the medicine lot of determination 

What i mean is he might have reversed it with diet and exercise...but it doesn't mean his disease is completely cured.

[csrcsr]

1 minute ago, Aquaman said:

What i mean is he might have reversed it with diet and exercise...but it doesn't mean his disease is completely cured.

Its the life style change you have to commit to once insulin resistance is there it will be there for ever, but blood sugar levels you have co trol by diets fasting etc etc