Page 128 - ESHRE2019

Clinical trials with hESC-derivatives Diabetes
Phase I: 6 patients, 2 EN250 Phase II: 36 patients, 4-6 EN250
Controls: EN20
PCC Stem Cells - ESHRE Vienna 2019
VC-01TM
Clinical trials with hESC-derivatives Type 1 diabetes
Two-year data from STEP ONE
International Pancreas & Islet Transplant Association (IPITA) meeting. May 2018 American Diabetes Association’s (ADA) 78th Scientific Sessions. June 2018.
PEC-EncapTM- VC01
• Safe and tolerability: The PEC-Encap product candidate appears to be safe and well tolerated. AEs related to surgical procedures and/or post-operative care. No off-target growth observed by ultrasound or histology
• Immunology Assessment: PEC-Encap protects against allo- and auto-immune rejection and sensitization. No donor-specific antibodies, no increase in auto-antibody titers, no tolerance or sensitization to donor cells, and no increase in lymphocyte stimulation or antigen-specific CD8+ T cell frequency post-implantation.
• Cell Differentiation and Survival: Differentiation into endocrine islet cells observed in both 12-week and two-year explants for both VC-01-250 and VC-01-20 units in regions with good host tissue integration and vascularization. Several two-year VC-01-250 explants with regions containing insulin-producing beta cells and glucagon-producing alpha cells
• When engraftment occurs, cells can persist for long durations without the need for immunosuppression.
126
123