A landmark study and trial could mean the end of daily insulin injections for persons suffering from diabetes. Scientists from the universities of California and Yale recently released information detailing that they discovered a way to boost the immune system and thus restore insulin production in the body for up to a year.
The discovery could mean big things for the 400 million people with diabetes worldwide; but, at the moment, only those who suffer from Type 1 diabetes would be able to benefit. The number of persons diagnosed with diabetes worldwide is astounding, and for many the need to inject themselves with insulin is a daily chore necessary to keep their blood sugar levels under control.
Diabetes is a disease which attacks the insulin-secreting cells of the pancreas, it is an auto immune disease and that means it causes the immune system to turn on itself, attacking not only foreign invaders but also the body’s own cells. Scientists advise that the human body needs the insulin hormone in order to allow the body to use sugar (glucose) from the food we eat to convert into energy or to store the glucose for future use. Insulin balances out the blood sugar levels and keep it from getting too high (hyperglycemia) or too low (hypoglycemia). In healthy human beings, billions of cells are responsible for “peacekeeping,” and they protect the cells making insulin from attacks by the immune system. These cells are called T-regs. Those with Type 1 diabetes do not have enough of T-regs and thus need the daily injections.
The University of Yale and California researchers’ discovery and success of the Phase I immunotherapy trial involves removing the regulatory T-regs — from the body and increasing their members drastically in a laboratory — by as much as 1,500 times before infusing them back into the bloodstream so they may continue their normal functions. T-regs reduce the immune system’s attack on insulin-producing beta cells and trial participants no longer needed daily injections. Telegraph mentions the lead author of the study is Jeffrey A. Bluestone, PhD, from the University of California, San Francisco (UCSF) and according to him the discovery “could be a game-changer.”
“For type 1 diabetes, we’ve traditionally given immunosuppressive drugs, but this trial gives us a new way forward. By using T-regs to ‘re-educate’ the immune system, we may be able to really change the course of this disease. We expect T-regs to be an important part of diabetes therapy in the future.”
The initial trial involved 14 newly-diagnosed Type 1 diabetes patients between the ages of 18-43 being given large populations of T-regs. The patients were divided into groups and the first ones were given roughly five million cells, while around 2.6 billion cells were received by the fourth group. This was the first time in the U.S. that such large numbers of T-regs were removed from the body, increased and then returned to the blood stream. The entire process is known as ex vivo (outside the body) “isolation and expansion.”
According to Diabetes.co.uk, one year after the procedure, 25 percent of the infused cells could still be detected in the circulation system of the study’s participants. Not only were there no adverse side effects, but in addition to stopping the need for daily injections the process also prevented the progression of the disease. This means that persons diagnosed with Type 1 diabetes who undergo ex vivo could potentially be saved from blindness and amputation later in life.
A New Jersey-based company, called Caladrius Pharmaceuticals, is currently in the early stages of planning a Phase II trial of T-regs following the successful Phase I trial findings. It is believed that the T-reg treatments will not only mean an end to daily injections for persons with Type 1 diabetes patients but also holds promise for treatment of other autoimmune diseases as well. This means that there may be hope for persons with lupus and rheumatoid arthritis, as well as those with cardiovascular disease, neurological diseases and obesity.
The research findings were published in the journal Science Translational Medicine.
[AP Photo/Reed Saxon]