Not WRONG read it again I know it mentions emergency use only check this out From the cellculturedish June 4 interview...clear evidence of MS efficacy in donated transplant lung function (ex spleen/harvested transplant lungs)...
"Athersys was also doing work with several of the leading transplant centers in the United States at this time. Investigators at these centers came to Athersys with a problem that is widespread in the field of lung transplantation. About seventy-five percent of lungs that are isolated from organ donors become highly inflamed and start to essentially go bad before the transplant procedure can be conducted. Once the lungs are harvested from the donor they are either put on ice or stored for the subsequent transportation procedure. The pulmonary tissue begins to experience inflammation, which causes the lungs to become compromised, (very frequently within just a few hours). The lungs become highly inflamed and filled with fluid, thus rendering them unusable. Doctors can’t transplant inflamed lungs into a patient needing a transplant because essentially they would have ARDS immediately. To see if Multistem could make a difference, investigators proposed taking lungs where there was severe inflammation and infusing one side with Multistem compared to the other side to be used as control. Since Athersys had seen restoration of pulmonary function and reduced inflammatory mediated cascade pathways in animal models, they had the basis for a study on human lungs that were isolated from donors. There was a dramatic impact when one side of the lungs was perfused with Multistem. It actually caused the pulmonary function to return to normal range and dramatically reduced the inflammatory mediated damage. The transplant specialists immediately suggested a study taking human lungs from donors and perfusing them with Multistem as a way to prepare these lungs for transplant. Ultimately though this represents a limited number of patients in the United States, somewhere around fifteen hundred to two thousand patients per year. With those numbers sufficient clinical trial enrollment would be difficult.
So Athersys decided to look at ARDS because it is the same clinical process and there are more patients with this affliction per year. Athersys ran a clinical trial at about a dozen leading pulmonary critical care centers in the United States and the UK. Dr. Van Bokkelen shared that the highlights from the one-year study follow up were recently announced demonstrating that Multistem helped patients in the short term by improving clinical metrics and odds of survival. In addition, Multistem dramatically improved quality of life outcomes for many of these patients, particularly among the most severely ill.
Another indication that Dr. Van Bokkelen described was using Multistem to treat ischemic stroke patients, another huge area of unmet medical need. He explained that after ischemic stroke, there is a very tight time window for patients to get to the hospital and then undergo treatment. Furthermore there are limited treatment options currently available. Athersys conducted a phase two clinical trial using Multistem for treatment of ischemic stroke. The study showed that Multistem could effectively help patients for up to thirty-six hours after they had suffered an ischemic stroke.
For both ARDS and for ischemic stroke Athersys has received fast track designation from the FDA. They are now well into a Phase III study for stroke patients with the belief that for both ARDS and for stroke, they can improve clinical care for patients that in many instances would otherwise have no good therapeutic options. Dr. Van Bokkelen, closed by saying, that providing therapeutic options where none previously existed was exactly why Athersys was founded twenty-five years ago and that this is the type of impact that they are really committed to making .. GOOD LUCK LONG
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