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Data in support of the clinical use of adipose derived MSC: growth, storage, function and safety

      Mesenchymal stromal cells (MSC) are a promising treatment for autoimmune disorders and tissue regeneration. Our laboratory has focused on an autologous approach using adipose tissue (AT) derived MSC (adMSC). In an effort to move these therapeutic cells into the clinic, we have performed studies to optimize and characterize the processes and the cells as the foundation of the manufacturing protocols for our clinical trials. Early on, we developed a media supplement derived from human platelets that is the basis of our culture protocol (PLTMax, Mill Creek Lifesciences, Rochester, MN). We have used this protocol to grow adMSC from otherwise healthy patients undergoing bariatric surgeries and from >30 patients with a variety of diseases including ALS, Crohn’s disease, type 1 diabetes, and ovarian cancer. We saw no differences in growth kinetics or phenotype associated with underlying disease. We have successfully cultured adMSC to more than 25 population doublings without loss of growth rate or change in phenotype. This protocol typically yielded 1 × 109 MSC in 3 weeks from a starting product of 1-2 gms of AT. When thawed, cells frozen for more than a year retained their pre-freeze proliferation rate. adMSC inhibited dendritic cell maturation as well as inhibited dendritic cell mediated stimulation of CD4 T cells. Safety studies in rabbits, pigs and mice have shown that cells have expected bio-distribution. No malignant transformation was seen during the injection of more than one billion adMSC into immune deficient mice. These and other preliminary data have led to the opening of phase I clinical trials using these cells to treat ALS, multiple system atrophy, and renal stenosis. Two other applications are under review.
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