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Home > News & events > News > Positive 14-month follow up data from Sana Biotechnology gives hope for people with type 1 diabetes
Hypoimmune (HIP) cells are cells that have been genetically reprogrammed in a lab. The HIP technology enables the cells to avoid the immune system. In type 1 diabetes (T1D), the immune system attacks and destroys the clusters of insulin-producing cells (beta cells) called islets. With HIP technology, these beta cells can be protected from the immune system, as if hidden.
In a traditional islet transplant, additional medication is required to stop the immune system from destroying the cells. These medications are called immunosuppressants and can have some undesirable side effects. With HIP technology, immunosuppression is not needed.
The results presented showed that in one person, the HIP modified islets have successfully evaded immune destruction for 14 months, which offers hope that islet transplantation without the need for immunosuppression may be possible for people with T1D in the future.
The function of these islets was tested using a number of methods. To measure if they were releasing insulin before and after meals the biomarker called C-peptide was used. C-peptide is released by the body when insulin is released, therefore it is a useful indicator of insulin production. And to measure how effective the transplant site was, PET-MRI scan was used.
The person who has received the treatment is still required to inject insulin. This is because the number of HIP cells transplanted was low. This early stage of the trial, known as ‘proof of concept’, aims to prove that the method works, in that the engineered cells can live and produce insulin.
Sana Biotech is planning to begin more wide-spread clinical trials for its HIP modified cells. The company is filing an investigational new drug (IND) application in the USA and planning to begin a phase 1 clinical trial this year.
Clinical trials have four different phases, where information on safety, efficacy and larger scale data is collected. The new treatment must successfully meet thresholds in all of these phases before it can be submitted for regulatory approval and people can access it. Each phase lasts a different length of time, with phase 1 being the shortest and phase 3 and 4 often the longest.
The T1D Fund, a Breakthrough T1D Venture, is proud to fund Sana Biotechnology and look forward to seeing the trial progress.
Rachel Connor, Director of Research Partnerships, said:
“These results are exciting for people with T1D. Although the number of cells transplanted was low, the survival of these cells for more than a year without immune suppression demonstrates clear progress in making cellular cures a viable option for many more people with T1D. We are proud to be supporting research that is breaking boundaries, as we strive for a world without T1D”
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