General Discussion
In reply to the discussion: London (Ontario) woman off insulin for Type 1 diabetes after a single dose of experimental manufactured stem cells [View all]Akakoji
(369 posts)Study listing, accepted in 2021. Most of the protocol is online. https://clinicaltrials.gov/study/NCT04786262
Article in NEJM: https://www.nejm.org/doi/full/10.1056/NEJMoa2506549 - https://www.nejm.org/doi/full/10.1056/NEJMoa2506549
Interesting they had to infuse directly into the hepatic portal. This is a transplant study that required a week of hospitalization during which immunosuppressive therapy was required. It's certainly more practical an approach than a multiple pancreas transplant. The entire protocol is online. All of the study participants were White.
Here are the authors peer-reviewed results:
RESULTS
A total of 14 participants (2 in part A and 12 in parts B and C) completed at least 12 months of follow-up and were included in the analyses. C-peptide was undetectable at baseline in all 14 participants. After zimislecel infusion, all the participants had engraftment and islet function, as evidenced by the detection of C-peptide. Neutropenia was the most common serious adverse event, occurring in 3 participants. Two deaths occurred one caused by cryptococcal meningitis and one by severe dementia with agitation owing to the progression of preexisting neurocognitive impairment. All 12 participants in parts B and C were free of severe hypoglycemic events and had a glycated hemoglobin level of less than 7%; these participants spent more than 70% of the time in the target glucose range (70 to 180 mg per deciliter). Ten of the 12 participants (83%) had insulin independence and were not using exogenous insulin at day 365.
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