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June 16, 2014
07:41 EDTNBSNeoStem presents results for Phase 1 study of autologous Treg immunotherapy
NeoStem announced the presentation of the results of an open-label dose escalation Phase 1 clinical study of autologous T regulatory cell, or Treg, immunotherapy for type 1 diabetes mellitus, or T1DM, indicating safety and tolerability following administration. As reported by UCSF, in the study, 14 patients between 18 and 45 years of age with a mean duration of disease of 10 months all of whom retained a baseline level of insulin production, received a single infusion of autologous Tregs expanded ~500-fold. The infusions were well tolerated; the majority of adverse events reported were mild. Infused Tregs peaked in circulation 3-7 days after infusion and were detectable at greater than 6 months. The average levels of stimulated C-peptide, an indicator of pancreatic islets beta cell function, for some patients remained stable from baseline for as long as 2 years post treatment. These data suggest that the treatment was safe and did not adversely affect residual beta cell function. The Tregs were observed to be highly functional and long lived in treated individuals. While the U.S. Phase 1 study was designed to evaluate safety and tolerability in adults who have suffered T1DM for various durations, supportive evidence of the utility of Tregs for T1DM in humans was provided by a study of pediatric patients with new onset T1DM. After 12 months of follow-up, about 66 percent of children treated were in remission, compared to only 20 percent of concurrent controls, and two Treg treated children achieved complete insulin independence, while none of the control children achieved this endpoint. Initiation of Phase 2 study is expected for Q3.
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December 8, 2014
07:35 EDTNBSNeoStem earns AABB re-accreditation for NJ manufacturing facility
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