Encouraging data from two small studies showing for the first time in humans how implantation of differentiated stem cells leads to good hormone production in patients with type 1 diabetes in a few months
A hundred years have passed since the discovery of insulin, the key hormone in sugar metabolism that patients with type 1 diabetes, and now two small clinical trials pave the way foruse of stem cells to replace the lack of hormone production: for the first time there is evidence that the approach works, although the insulin produced by transplanted stem cells did not have consistent clinical effects and therefore, for example, did not allow to do without injections.
Stem cells implanted
The cells used for the implants are pancreatic endodermal cells derived from pluripotent human stem cells thanks to a protocol developed a few years ago; the endoderms, once transplanted into animal models, have been shown to be able to further differentiate into mature cells, capable of producing insulin. The two research groups therefore tested them on 26 people with type 1 diabetes, implanting them under the skin; patients were treated with immunosuppressants, with the same regimen used in the case of a pancreatic islet transplant, to avoid rejection. In the first study, published in Cell Stem Cell
, the cells became capable of secreting insulin within 26 weeks: within a year, patients had a 20 percent reduced insulin requirement and they spent 13 percent of the extra time in the right blood glucose range. The second study, released simultaneously on Cell Reports Medicine
, confirms that the feasible approach: Three to twelve months after surgery, 63 percent of the implants were producing insulin.
Still a long way to go
In both cases there was no lack of adverse events, mainly related to immunosuppressive treatment or surgical procedures; however, the reactions at the implantation site were very scarce and in general the implant itself was well tolerated the cells continued to function for up to 59 weeks after surgery, with no tumor changes occurring. Analysis of the implants removed in some patients also showed that the cells differentiated into classic pancreatic beta cells that produce insulin. It is a matter of a few cases, with results which, moreover, have proved to be very variable between one individual and another; Furthermore immunosuppressive therapies needed to prevent rejection have been the main cause of problems, an element that for the moment makes this road still not feasible on a large scale. Many questions remain to be answered, from the ideal differentiation stage of the cells to be transplanted to the best implantation site, from long-term safety and efficacy to the possibility of finding ways to avoid immunosuppressants; however, as the authors conclude, it finally opened a new era of clinical application of stem cells for diabetes therapy: the road to making it available to many will be long and complex and until then pancreatic islet transplantation will continue to remain an option for a few selected cases, but the first results encourage further studies.
December 5, 2021 (change December 5, 2021 | 13:01)
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