Hello,
My team working towards preparing an IND application. We plan to use patient's somatic cells, reprogramming them to induced pluripotent stem cells (iPS) and differentiating them to diseased cells and finally implant them back to the patient - autologous cell therapy. My concern is if this will be considered as gene therapy or cell therapy by FDA.
We will reprogram the cells to make them iPS cells, but them the final product going into the patients will be mature normal healthy cells derived from patient with no genetic corrections. These implanted cells will be basically replacing the old degenerating cells in the patient.
Can we call this as cell therapy?
Thanks.
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Balendu Shekhar Jha
Rockville MD
United States
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