In an article published in the Journal of Translational Medicine, Chinese stem cell research company Beike Biotechnology, reported positive safety data in 114 patients who were treated by doctors at Nanshan Affiliated Hospital of Guangdong Medical College in Shenzhen, using Beike's proprietary cord blood stem cell transplantation protocol.
The report aims to serve as an "expanded phase I" study, with efficacy data to be published in a subsequent paper. It describes biochemical, hematological, immunological, and general safety profiles of patients with neurological diseases who were observed from between one month to four years after treatment. No serious treatment-associated adverse effects were observed.
Dr Wanzhang Yang, who led the study at Nanshan Affiliated Hospital of Guangdong Medical College commented, "This important study, which is the largest of its kind, demonstrates the safety and efficacy of using cord-blood-derived stem cells to treat a variety of neurological conditions. However, it also suggests cord-blood-derived stem cells are a safe and viable treatment option for a much broader range of diseases and conditions than previously thought."
Because the protocol developed by Beike allows the use of cord blood stem cells without immune suppression, it can be made available to a wide patient population. Until now, patients receiving cord blood transplants to fight hematopoietic diseases were immune-suppressed in order to prevent a potentially devastating condition known as "graft versus host." This new research challenges the necessity of that practice.
Medistem CEO Thomas Ichim stated, "It is an honor to collaborate with Beike on this seminal publication. The fact that Beike has been able to demonstrate safety of transplant by manipulating an established stem cell source is a substantial advancement for the field. These new findings could open up the use of cord blood for non-hematological diseases, something that to date has not been performed on a wide-spread basis."
Dr Travis Ye, Beike Biotech's CEO, commented, "This groundbreaking research is consistent with the safety record we have compiled after providing stem cells for the treatment of more than 8,000 patients. It is our hope that studies and peer-reviewed articles such as this one, will help strengthen our ties to the western medical and scientific research community, by demonstrating that Beike's stem cell protocols are both effective and safe."
The study was conducted by a team of researchers from Beike, Medistem, Nanshan Affiliated Hospital of Guangdong Medical College, the University of Western Ontario (Canada), and University of California, San Diego, USA