Clinical study


Traumatic brain/spinal injury is a penetrating injury mainly caused by traffic accidents, work injuries, violent incidents, etc. These injuries usually result in complete or partial transection of the brain/spinal nervous system, which in turn cause severe and permanent disabilities. Secondary progressive mechanisms of brain/spinal injury usually begin within a few minutes and develop within hours of being injured. The process of secondary progression is complex, which possibly involves mechanisms including ischemia, hypoxia, inflammation, edema, excitotoxicity, ion homeostasis and apoptosis.


It is generally believed neurological impairment in patients normally takes only 6 months to recover, and continuous recovery in neurological function is hardly seen after 6 months. Stem cell technologies have tremendous potential for treatment of diseases involving neurological impairment, including spinal cord injury. Not only are many research institutions watching closely developments in this field, new policies are also emerging to support and promote the clinical application of stem cell treatment on diseases such as spinal cord injury.


In the past few years, good results obtained in animal studies have given scientists confidence in the efficacy stem cells have on spinal cord injuries. In many clinical studies being conducted internationally, many patients have recovered sports capacity, and the quality of life has been greatly improved. Hospitals in China have also carried out a number of clinical studies and got good results - some paralyzed patients miraculously stood up from wheelchairs after being treated with stem cells.


It is precisely because of the bright prospects in this field that a key national development plan titled "Stem Cells and Their Clinical Research" allocated in September 2018 dedicated funds to support studies using stem cells to treat spinal cord injuries.


In collaboration with Stanford University, Stemedica conducted a study on neural stem cells for treatment of spinal cord injuries using a mouse model. The results showed that mice in the treatment group achieved obvious recovery compared with the untreated group. For mice in the platform stage, the effect of distal intrathecal injection is significant. This study won the Best Basic Research Award given by American Society of Plastic Surgery.


Another FDA-approved clinical study Stemedica sponsored used bone marrow mesenchymal stem cells to treat traumatic brain injuries. The cells worked miraculously on some patients treated with emergency IND. A vegetative state boy who suffered from brain axonal injuries in a car accident was treated with BMSCs, and his sports capacity was basically restored. He was subsequently given neural stem cells treatment, which helped regain his language ability for more than 85%, and now he is back to school. An US gymnast got his cervical vertebra injured during training, resulting in high paraplegia. Three years of conventional treatment did not work on him. After being treated with Stemedica’s BMSCs, he recovered sports capacity in upper limbs and participated the 2016 Rio Paralympics later, in which he achieved excellent results.