Gabriel Nistor, M.D.
Chief Science Officer
Dr. Nistor has been involved in many clinical research projects in numerous fields and conducted seminal research at University of California, Irvine between 2000 and 2010. He has broad, multidisciplinary knowledge and skills in all science areas, with primary expertise in the biological and medical fields.
He is a world leader in stem cell and spinal cord injury research and has developed many novel methods and procedures to the advancement of those fields. In 2004, under the direction of Hans Keirstead of the Keirstead Research Group at UC Irvine, Dr. Nistor successfully co-developed a human embryonic stem cell derived treatment for acute spinal cord injuries in rats. That treatment was approved by the FDA for clinicial trials in humans with acute spinal cord injuries. The trial, currently in progress sponsored by Asterias Biotherapeutics, marks the first human embryonic stem cell trial ever approved in the U.S.
Prior to joining AIVITA Biomedical, Dr. Nistor served as Vice President, Research at Caladrius Biosciences. There he created a quality-by-design environment compliant with modern cGMP practices to support the research, development and manufacturing troubleshooting of a phase III clinical trial for advanced stage melanoma using autologous tumor initiating cells and autologous dendritic cells.
From 2006-2014 Gabriel served as Vice President, Research and Development at California Stem Cell, Inc. There he developed and patented reagent, manufacturing processes, in-process control and releasing criteria for stem cell derivates suitable for cell-replacement therapies. He developed methods for differentiating human embryonic stem cells in high purity populations of oligodendrocytes, neurons, cardiomyocytes, and hepatocytes. During his time at California Stem Cell, he also developed an in vitro human neuro-muscular system from stem cell-derived motor neurons and primary myoblasts differentiated to skeletal muscle. He developed a concept and conditions for stemness maintenance, stem cell niche and differentiation mechanism of human embryonic stem cells, used successfully to grow very large quantities of cells with regulatory compliance. Following the acquisition and successful technology transfer of a Phase III immune-therapy for late stage metastatic melanoma, he improved manufacturing for purified tumor initiating cells with a new set of reagents and methods designed for a higher success rate.
Gabriel’s recent scientific accomplishments include successfully isolating and expanding circulating tumor cells from cancer patients and identified factors that allow survival of the cells in routine blood samples. He has developed proprietary reagents and methods that enabled consistent isolation of cancer “stem” cells from bulk tumors and rapid expansion for use as antigenic sources. Gabriel has also investigated the feasibility and established methods for the manufacture of purified tumor stem cells as antigen sources for autologous immune-therapy approaches in other types of cancer including hepatocellular carcinoma, ovarian cancer, non-small lung cancer, glioblastoma, and more. He has also developed a final product potency assay and discovered clinical predictive and efficacy biomarkers for dendritic cell based immune-therapy that could complement the current approaches based on checkpoint inhibitors. Using complex investigative methods that included exomic analysis of the purified tumor “stem” cells and mixed lymphocyte reactions elucidated multiple pathways of immune response to strong or weak antigens resulted from cancer associated mutations equally suggestive for immune-escape and tumorigenesis.
Dr. Nistor has submitted and been awarded multiple grants from agencies including CIRM and NIH totaling over $20 million.