The University of Kentucky will be the first site in the state and one of a select few in the entire country participating in the first stages of a groundbreaking study to investigate the effects of MultiStem, a human adult stem cell product, on patients with acute ischemic stroke. The phase II clinical trial, known as Atherys stroke protocol B01-02, was recently approved by UK's institutional review board.
"Adult stem cells may have great potential in stroke treatment, and we need to approach it scientifically. We are excited to be the first to bring a clinical trial of stem cells for stroke to Kentucky," said Dr. Michael Dobbs, director of the UK HealthCare Stroke Affiliate Network and principal investigator on the stem cell trial.
Despite recent advances in interventional ischemic stroke treatment, medical therapy for the treatment of stroke has largely been limited to tPA, the clot-busting drug that received FDA approval in 1996.
Using stem cells in the treatment of stroke represents a novel approach to treating the damage caused by stroke. Studies of animal models suggest that stem cell therapy may offer a unique neuro-protective effect, and further investigation as to the mechanism of this benefit is currently underway.
MultiStem is also being studied as a potential treatment for a variety of diseases, with the therapy already successfully completing a Phase I trial in patients suffering from Graft Versus Host Disease (GVHD), a potentially deadly complication of bone marrow transplantation in cancer patients.
"UK's selection as one of the first sites for this study exemplifies our position as a national leader in cutting edge stroke therapy and research. By pioneering new approaches to stroke treatment, we are doing our part to ensure that our stroke patients receive the absolute best care possible," Dobbs said.