The First Phase III Trials of Stem Cell Therapy for Spinal Cord Injury Successfully Applied For Registration and Got Approval of U.S. FDA in the World
Stem Cell Transplantation Center of General hospital of Chinese People's Armed Police Forces and the 309th Hospital of Chinese People's Liberation Army successfully finished Phase II trials of stem cell therapy for spinal cord injury of FDA and got approval to start Phase III trials. This means that China has ranked among the advanced in the world in the area of stem cells treating spinal cord injury.
Spinal cord injury refers injuries caused directly or indirectly by external factors in the spinal cord and is always accompanied with some symptoms below the injured level. They include motor movement, sensation and sphincter dysfunction, abnormal muscle tension, and pathologic reflex and so on. It often occurs among young groups under the age of 30. Patients can’t take care of themselves in the long term once have spinal cord injury, increasing the risk of various complications. Thus the health and lifespan have been influenced significantly and the survival rate of traumatic spinal cord injury decreases about 30% compared to the normal people. With the development of industrial economy, the occurrence rate of spinal cord injury has increased gradually. Researches show that, for example in Beijing annual incidence was 6.18 per 100,000 people in the late 1980s, but it became 60 per 100,000 in the 21st century. In such a short time, the incidence of spinal cord injuries increased nearly 10 times. The growing number of individuals with spinal cord injury has brought increasingly heavy economic burden and social pressure for the whole society. Currently the treatment for spinal cord injury especially sequel is mainly depended on rehabilitation measures for some complications like bedsore, urinary tract infections, respiratory infection and nutritional failure. The traditional methods can’t improve the damaged nerve function fundamentally, and only symptomatically relieve high muscle tension and joint stiffness. How to make the damaged nerves repair or regenerate becomes a difficult problem in medicine.
In 2000 with the care and advocacy from Academician Zhongcheng Wang, Pro. Yihua An started Beijing Neurosurgical Institute Stem Cell Research and was engaged in the basic research of stem cell transplantation. In 2003 he with his medical team first completed neural stem cells transplantation for primate cerebral hemorrhage sequelae, and creatively established a whole set of optimized laboratory operating procedures of cell cultivation, screening and differentiation (SOP). In 2004 Stem Cell Transplantation Center was founded, which is the first neural stem cell transplantation center at home and abroad. It treats central nervous system injury patients like spinal cord injury. Now our center has treated more than 10,000 patients from over 30 countries, among which there are over 3,000 patients with spinal cord injury.
The scientific standardization research management is necessary when the stem cell therapy got through from basic research to clinical application, and eventually becomes clinical treatment. In 2010, though Chinese Health Authorities didn’t have strict rules and regulations in clinical application of stem cells, Stem Cell Transplantation Center submitted clinical trials of stem cells transplantation for central nervous system injuries damage to expert committee through WHO Chinese Clinical Trial Registry and FDA according to the related strict clinical trial rules of WHO and FDA. Our center has practiced international normalized management of human clinical trials and scientific research project in China, and proposed specificity of Chinese patients and diversity of treatments methods. The network of stem cell therapy research and clinical application was formed centered with the General Hospital of Chinese People's Armed Police Forces and the 309th Hospital of Chinese People's Liberation Army and united many other domestic hospitals.
Until now 20 items have been approved by WHO AND 6 items approved by FDA. All the items have been carried out and 11 clinical registration items of Phase I and III concerning about stem cell transplantation treating cerebral palsy and spinal cord injury sequelae and so on have been completed on schedule. Stem cell therapy for spinal cord injury sequelae reported and audited in 2012 has obtained registration assessment of Phase III registration. Stem cell therapy treating infantile cerebral palsy is applying for Phase III registration and the Phase III registration items of stem cell treatment for traumatic brain injury sequelae, cerebral hemorrhage sequelae and stroke sequelae will be completed in succession.