The first clinical trial in the United States of a new form of immunotherapy for type 1 diabetes showed no serious side effects after the administration of up to 2.6 billion T-cells protecting the pancreas.

On the successful completion of the test, members of the University of California in San Francisco reported on the pages of the journal Science Translational Medicine.

In type 1 diabetes, the human immune system, which must resist infections, begins to damage insulin-producing pancreatic cells, reducing its ability to secrete insulin.

Many modern methods of treating type 1 diabetes mellitus are aimed at suppressing this immune response, however such an approach can have serious consequences, because the weakening of the immune system makes the body immune to infections and cancer.

During the last test, American scientists tested so-called regulatory T cells, which are able to stop the attack against the pancreas, while retaining the ability of the immune system to resist foreign agents.

"It can change the rules of the game. With type 1 diabetes, we have traditionally been prescribed immunosuppressors, but regulatory T cells are a completely new approach to treatment. Using these cells, we can "retrain" the immune system and really redirect the course of the disease, "explains lead author Dr. Jeffrey Bluestone, professor of endocrinology at UCSF.

Encouraged by the results of the first phase of the tests, Professor of Pediatrics at Yale University, Dr. Kevin Herold, supported the second phase to introduce regulatory T cells as soon as possible into clinical practice. According to the famous scientist, immunotherapy with insulin-dependent diabetes mellitus will "give new hope" to American patients who today can rely only on risky and ineffective drugs.

Recall that the technology of isolation and extraction of regulatory T-lymphocytes for the treatment of diabetes was first described by Bluesstone in 2009. Almost 6 years it took scientists to pass all the bureaucratic obstacles and come close to the second phase of the tests.

For treatment with regulatory T cells, physicians first take a little blood from the patient, enough to isolate 2-4 million desired cells. Then, using fluorescent sorting (FACS) in the laboratory, the regulatory T cells are carefully separated from millions of cells of other types. They are placed in a nutrient medium for growth, where the population of T-lymphocytes is increased 1500 times - from 2 million cells to 3 billion.

In the course of his past research, Blyustoun and his colleagues activated the cells and demonstrated that after that they can correct defects in the immune system of patients with type 1 diabetes, and also can survive longer in the body.

In the first clinical trial in the United States, 14 patients aged 18 to 43 years who had recently been diagnosed with type 1 diabetes mellitus. Participants were divided into 4 groups that received different doses of T cells: the first group received 5 million cells, and the fourth group - 2.6 billion.

Cell therapy was well tolerated by patients of all four groups. One year after a single intravenous injection, up to 25% of regulatory T cells remained in the blood of patients, performing their work.

"The positive test results are especially encouraging, because with T-cell cancer, in some cases, the patient's immune system" got out of control ". After the favorable results of the first phase of the study, we are preparing for the second phase, "Caladrius Pharmaceuticals said in a statement that is developing a new method for treating diabetes.

One of the participants in the test, 39-year-old Mary Rooney, suffers from type 1 diabetes for about 4 years. She says that after treatment with regulatory T cells she did not experience any problems, and she hopes for the speedy success of Dr. Blyustoun.

"The introduction of T cells helps stop the development of type 1 diabetes, freeing people like myself from the terrible daily insulin therapy, and prevents serious complications in the future. This is truly a revolutionary study with enormous potential, "says Mary.

According to Blyustoun himself, he has ideas on the use of regulatory T cells not only in the treatment of diabetes mellitus, but also in many other autoimmune diseases, including lupus and rheumatoid arthritis.

Even with obesity, cardiovascular and neurological diseases of cellular therapy, there is a worthy place.

Significant funds from the Parker Foundation in the amount of $ 10 million many times accelerated work on the new therapy, for which scientists are infinitely grateful to the philanthropist from Silicon Valley. Sean Parker, a 35-year-old co-founder of Facebook and Napster, at his own money, opened a laboratory for the study of autoimmune diseases, the first director of which was Dr. Bluestone.

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