BACKGROUND: There is increasing evidence of therapeutic benefits from bone marrow (BM)-derived mesenchymal stromal cells (MSC) in various animal models with neurologic disorders. It is of great interest to apply the approach to clinical patients, i.e. to take the investigations from laboratory bench to the patient's bedside. This clinical trial was performed to assess the safety and feasibility of a combined procedure to deliver autologous MSC to patients with traumatic brain injury. METHODS: MSC were isolated by BM aspiration and expanded in culture. Seven patients received autologous cell transplantation. A primary administration of 10(7)-10(9) cells was applied directly to the injured area during the cranial operation; a second dose of 10(8)-10(10) cells was infused intravenously. All patients were followed up regularly for 6 months. RESULTS: There was no immediate or delayed toxicity related to the cell administration within the 6-month follow-up period. Neurologic function was significantly improved at 6 months after cell therapy. DISCUSSION: The procedure used is safe and feasible at ordinary medical facilities without additional invasive procedures for the patient. The combined cell delivery procedure is expected to enhance the engraftment efficacy of transplanted cells at injured brain tissue, thereby promoting neurologic recover.
BACKGROUND: There is increasing evidence of therapeutic benefits from bone marrow (BM)-derived mesenchymal stromal cells (MSC) in various animal models with neurologic disorders. It is of great interest to apply the approach to clinical patients, i.e. to take the investigations from laboratory bench to the patient's bedside. This clinical trial was performed to assess the safety and feasibility of a combined procedure to deliver autologous MSC to patients with traumatic brain injury. METHODS: MSC were isolated by BM aspiration and expanded in culture. Seven patients received autologous cell transplantation. A primary administration of 10(7)-10(9) cells was applied directly to the injured area during the cranial operation; a second dose of 10(8)-10(10) cells was infused intravenously. All patients were followed up regularly for 6 months. RESULTS: There was no immediate or delayed toxicity related to the cell administration within the 6-month follow-up period. Neurologic function was significantly improved at 6 months after cell therapy. DISCUSSION: The procedure used is safe and feasible at ordinary medical facilities without additional invasive procedures for the patient. The combined cell delivery procedure is expected to enhance the engraftment efficacy of transplanted cells at injured brain tissue, thereby promoting neurologic recover.