Osiris (OSIR) was founded on the basis of technology that promised development of stem cell treatments. More precisely that meant Dr. Caplan (one of the founders) first described cells that were stuck to the plate, after culturing cells isolated from the bone marrow. Not only did he notice their capacity to adhere but also their ability to differentiate into different types of cells. Today, decades after the discovery and further research efforts, we know a little bit more about these cells.
They are called Mesenchymal Stem Cells (MSC) and unlike stems cells talked about in media, the ones whose current research development just got restarted by the federal government, these stem cells (MSCs), are not a part of moral debates. They are isolated from healthy adult donors and still have the capacity to differentiate. They can be precursors to a number of mesodermal tissues such as bone, cartilage, fat and muscle.
They are rare and currently they are thought to be present in the bone marrow at 1 to 100,000 ratio, compared to the rest of cells within. A few studies have shown that in their nascent state they have the ability to suppress the immune response, which would make them attractive therapeutics for inflammatory disease.
Clinical Trials – Exude Confidence with Minor Drawbacks
Supporting immune suppression phenomenon of MSC, Osiris has Prochymal in three phase III trials for three different indications; acute and steroid refractory Graft versus Host Disease and Crohn's disease. Prochymal finished recruitment of patients for Clinical Trial for the Treatment of Chronic Obstructive Pulmonary Disease and is recruiting patients for their Phase II Type I Diabetes trial and just finished Phase I Clinical Trial for the Treatment of Damaged Myocardium Following an Acute Myocardial Infarction. The postulate of all these indications is that they are all caused by some sort of inflammation that is detrimental to the body; hence suppressing it by Prochymal could be a valid treatment option. There is also another formulation of MSC called Chondrogen tested in knee repair in Phase I/II.
Acute Graft versus Host Disease
Phase II trial showed a 74% of patients treated with Prochymal and steroids had a complete response; compared to 35% of patients who had a complete response to steroids alone (please note that this study didn't compare Prochymal and steroids vs. steroids alone but rather referenced response rates of another study that treated patients with steroids alone).
Steroid-refractory acute GvHD
They are recruiting for Phase III trial, but there is no information on Phase II on their website or clinicaltrials.gov.
Phase II evaluated 10 patients (who failed all other current therapies) and showed statistically significant reduction in Crohn's Disease Activity Index or CDAI of scores of 105 points by day 28 from 341 to 236 (p=0.004).
Chronic Obstructive Pulmonary Disease (COPD)
Phase I is finished, however nothing is reported on it. They are recruiting for Phase II.