Medistem reports first human use of universal donor combination adult stem cell therapy in spinal cord injury.
The patient treated, who was 29 years old at the time, suffered a spinal cord injury resulting from an airplane crash on 13 May, 2008. He had no walking ability, intermittent pain and loss of sexual function. The patient was injected with a combination universal donor stem cell therapy in November 2008, and January and July 2009. A gradual improvement was observed subsequent to each administration of stem cells.
Currently the patient has recovered sexual function, is walking, and has a dramatic reduction in pain symptoms. The medical article describing the procedure was published in the peer-reviewed journal International Archives of Internal Medicine and was co-authored by scientists at the University of California San Diego, Indiana University, and University of Utah.
“While we cannot make any conclusions based on the treatment of only one patient, we are very excited to see such a drastic improvement,” said Vladimir Bogin, chairman and president of Medistem.
Medistem has filed an Investigational New Drug Application (IND) with the FDA for use of its universal donor endometrial regenerative cells for treatment of critical limb ischaemia.
“We aim to initiate clinical trials in the USA in the first quarter of 2011. Through this we hope to take data from promising case reports, such as the one discussed today, into the scientific framework required by the FDA for going down the path to full registration,” said Sergey Sablin, vice president of Medistem. “The fact that Endometrial Regenerative Cells can be made into lung, liver, brain, pancreatic, bone, fat, blood vessel, heart, and muscle tissue suggests that these cells may be useful for numerous diseases.”
“To date we have published patient results in multiple sclerosis, heart failure, Duchenne Muscular Dystrophy, and now spinal cord injury,” said Vladimir Zaharchook, vice chairman and board member of the company. “While we as a company are focused on our critical limb ischaemia programme, we are optimistic about the other clinically-applicable uses of the endometrial regenerative cells and are currently seeking strategic partners.”