Twelve volunteers with severe type 1 diabetes showed a clear improvement in their condition 12 months after receiving innovative stem cell therapy, with all but two people completely dropping insulin therapy.
Phase 1/Phase 2 clinical trial results give hope to 8.4 million people worldwide with type 1 diabetes. Autoimmune state in which the immune system damages insulin-producing cells.
While more extensive research is needed to see how long the benefits of treatment last, new treatments developed by Boston-based apex drugs provide strong evidence that stem cell injections can be used to replace lost insulin production in the body.
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People with type 1 diabetes rely on an unstable balance of lifelong insulin therapy. If insulin is too low, cells cannot use sugar in the bloodstream, leading to accumulation that can damage organs. If insulin is too high, the patient may enter hypoglycemia and lose consciousness, seizures, coma, or death.
Pancreatic islet cells are responsible for maintaining most of our body's insulin levels. Donor implantation of healthy versions of these cells has shown promise in the past for type 1 diabetes, but multiple donors are required, and donors are rare.
Therefore, University of Toronto surgeon Trevor Reichmann and colleagues inject 12 patients with islet cells derived from human stem cells in a treatment known as jimisulcells.
The patients also received immunosuppressive treatment before and after the jimisulcell injection. Not only did the islets produce insulin in the body, they did it at a safe level, reducing the patient's costly reliance on insulin.
“These findings showed that dimisulcell islet cells are functional and properly self-regulated,” the researchers wrote in their paper.
Mild to moderate side effects, including reduced renal function and expected decline in immune cells, were all associated with immunosuppressive therapy. Sadly, two additional participants died during the trial. One comes from infections resulting from surgery, and the other from complications caused by unrelated conditions.
The clinical trial is progressing to stage 3, as there were no serious adverse events caused by new islet cell therapy.
“These findings provide evidence that islets can be effectively generated from pluripotent stem cells and can be used to treat type 1 diabetes,” concludes Reichmann and the team.
This study was published in NEJM.