Manufacturing Development of Allogeneic Stem Cells in Clinical Settings

Cellular therapies are rapidly moving toward widespread clinical application in cancer treatment, autoimmune disease control and trauma recovery. Human adipose tissue, an available waste product from reconstructive and plastic surgery, is becoming a most popular source of adult stem cells, which are already being applied in autotransplant situations. For allogeneic transplants a leap-ahead manufacturing process that isolates desired and eliminates undesired cell types at a high processing rate is required. Techshot, Inc. will work with collaborators at the University of Pittsburgh and IKOTECH, LLC to (1) refine quadrupole magnetic cell sorting (QMS) equipment and supplies for validated manufacture under cGMP rules, (2) prepare for Investigational New Drug (IND) applications by manufacturing at least three clinically acceptable mesenchymal stem cell products from adipose tissue digests using the resulting equipment and single-use kits and Standard Operating Procedures in a clinical setting, and (3) utilize the results to meet FDA requirements for a FDA Device Master File (DMF). Successful conclusion of this project will prepare QMS for use in clinical trials of interest to the Armed Forces Institute for Regenerative Medicine (AFIRM) and will enable new therapies in the high-growth civilian regenerative medicine market.