MSC prediction algorithm

A method of treating a patient in need thereof for a disorder selected from the group consisting of autoimmune disorders, inflammatory disorders, and transplantation associated complications, comprising:

• evaluating in vitro the in vivo efficacy in a patient of treatment with a drug product, comprising:
• measuring at least properties (a) and (b) or at least properties (b) and (c) by at least two assays, wherein the properties are:
• (a) the in vitro reaction of said patient's own immune cells when exposed to the drug product;
• (b) the reaction of said drug product when exposed to said patient's own immune cells;
• and
• (c) any preexisting antibodies in said patient, which antibodies exhibit affinity for said drug product, wherein for property (c) serum from the patient is analyzed for the presence of anti-HLA antibodies with specific affinity for the drug product;
• determining the product as efficacious based on at least properties (a) and (b) or at least properties (b) and (c) if the results in (a) and/or (b) show at least two of:
• 1) a decrease of proinflammatory immune cells proliferation;
• 2) a decrease in secretion of proinflammatory molecules;
• 3) switching of immune cells from a proinflammatory to an anti-inflammatory phenotype;
• 4) apoptosis of CD8+ T cells;
• 5) apoptosis of memory B cells;
• and
• 6) apoptosis of memory T cells;
• and/or if the results in (c) show (i) no anti-HLA antibodies are detected or (ii) anti-HLA antibodies with no specific affinity for HLA are detected, wherein no specific affinity refers to a KD value of 10−4 M or lower affinity;
• and
• administering the drug product to the patient to treat the autoimmune disorder, inflammatory disorder, or transplantation associated complication;
• or otherwise determining the drug product as inefficacious and withholding the drug product from the patient;
• wherein the drug product comprises a mesenchymal stem cell (MSC) population.