Stem Cell Trials Slowly Progressing
News of another step towards the availability of autologous stem cell therapies in US clinics: "Using a patient's own bone marrow stem cells to treat acute stroke is feasible and safe ... The trial was the first ever to harvest an acute stroke patient's own stem cells from the iliac crest of the leg, separate them and inject them back into the patient intravenously. ... In order to bring stem cells forward as a potential new treatment for stroke patients, we have to establish safety first and this study provides the first evidence in addressing that goal. Now we are conducting two other stroke cell therapy studies examining safety and efficacy, one of which can be administered up to 19 days after someone has suffered a stroke. ... Of the 10 patients enrolled in the study, there were no study-related severe adverse events. ... Although the study was not intended to address efficacy, the investigators compared the study group with historical control patients ... In that comparison, the study team found a number of patients who did better compared with controls. However, [that] type of analysis has limitations." The US medical development community is years behind Korean and even Brazilian researchers in this work, who were testing bone marrow stem cells for stroke in humans back in 2004 and 2005. That sort of delay, and the financial costs accompanying it, are some of the consequences of the regulatory policies of the FDA.