Stem Cell Res Ther 2021 May 10;12(1):279. Epub 2021 May 10.
Stempeutics Research Pvt Ltd, 3rd Floor, Manipal Hospitals Whitefield Pvt. Ltd., #143, EPIP Industrial Area, K R Puram Hobli, Bengaluru, India.
Background: We have previously demonstrated that a pooled population of bone marrow-derived, allogeneic mesenchymal stromal cells (BMMSC), Stempeucel®-1, produced under good manufacturing practices (GMP) conditions, showed clinical efficacy and safety in patients suffering from critical limb ischemia (CLI) due to Buerger's disease. While Stempeucel®-1 is currently used for CLI and other clinical indications, we wanted to ensure that the product's continuity is addressed by developing and characterizing a second generation of pooled product (Stempeucel®-1A), manufactured identically from second BM aspirates of the same three donors after a 2-year interval.
Methods: The two versions of Stempeucel® were manufactured and subjected to gene and protein expression analysis. Read More