On February 8, 2007 in laboratories at the University of Navarra, Pamplona, Spain, professor Jose Obeso transplanted the subject, a healthy monkey, with BrainStorm’s human bone marrow derived mesenchymal stem cells. The stem cells had been induced to differentiate into neurotrophic factor-producing cells, according to the protocol developed at the company’s laboratories in Israel.
The monkey was treated daily with cyclosporine to prevent rejection of the human originating cells by its immune system, and was monitored for a variety of parameters for a period of three months. Throughout this phase, the monkey appeared well and in good health, with a usual appetite, and with no apparent change in physical and behavioral parameters. Blood tests, an MRI of the monkey’s brain and an autopsy examination of the internal organs were also found to be normal.
Additionally, brain tissues from the monkey were examined by Professor Jeffrey Kordower, from Rush University, Chicago. A few human originating cells were detected in sections of the monkey’s brain by staining the sections with an antibody, which can distinguish between the monkey’s own brain cells and the human transplanted cells.
The human transplanted cells were surrounded by macrophages, which may indicate a reaction of the monkey’s immune system to the transplanted human cells and their initial rejection. BrainStorm said that its actual approach would involve autologous transplantation (i.e., the use of the patient’s own bone marrow-derived stem cells). With this strategy, no rejection is expected and there will be no need to suppress the immune system by medications that often cause severe side effects.
“The recent financing the company has received will, with G-d’s help, allow BrainStorm to move forward with the preparations necessary toward carrying out Phase I/II clinical trials in patients with Parkinson’s disease, and providing the funding and support needed to conduct additional safety pharmacology studies, such as toxicology,” commented Chaim Lebovits, president of BrainStorm.
Two additional normal monkeys recently underwent transplantation in Pamplona with BrainStorm’s human stem cells. The monkeys will also be monitored for a period of three months for collection of additional data; so far, the monkeys are in good health.