Surgical Interventions & Neuroprotection
Each year approximately 12,000 new cases of traumatic SCI occur in the United States. Through the development of better critical care procedures in the initial minutes and hours after an injury, more patients are surviving these severe injuries and living long productive lives. Another STEP that was also emphasized in 1997 was surgical interventions and neuroprotection. These topics are relevant as we consider therapeutic strategies to target the acute and more chronic injury states. For example, refined surgical measures including early decompression procedures are improving outcomes by reducing cord swelling and improving blood flow to the damaged cord. In subjects where cellular transplantation into the injured spinal cord is proposed, a reproducible and safe approach needs to be established and tested to administer millions of cells to protect and enhance circuit reorganization and repair. Miami Project researchers have spent the last several years developing and testing transplantation strategies that we can utilized in individuals with acute or chronic spinal cord injury.
Using both small and large animal models of spinal cord injury, evidence for the successful application of cells into the injured spinal cord has been developed. During this testing period, our scientists worked with biotech companies and surgical colleagues to help promote the successful translation of these cell transplantation procedures to people. We know from previous clinical trials conducted by others in the field that injecting cells into the spinal cords of people can have adverse effects. Thus, this was an important step that had to be mastered prior to initiating our clinical studies. An FDA approved approach for administrating cells safely into the injured spinal cord is currently being used in our clinical trial.
The use of Therapeutic hypothermia as a powerful means to protect the brain and spinal cord from irreversible damage has also been introduced into the clinical area. In patients with out-of-hospital cardiac arrest as well as in infants that undergo a hypoxic insult during delivery, multicenter trials have shown that early cooling is protective and improves long term survival and function. In the areas of Stroke, spinal cord injury, and traumatic brain injury, therapeutic hypothermia is also being tested in patients with encouraging results. Indeed, multicenter trials led by the Miami Project have been planned and should provide the safety and efficacy data necessary to conclude whether hypothermic therapy in thousands of neurotrauma patients is beneficial. These seminal studies may help change the way we treat people with these severe injuries. It is very gratifying to know that our research and clinical programs have already helped change medical practice in a way that has helped patients with severe injuries.
In addition to hypothermia research, the discovery and testing of a number of neuroprotective molecules and drugs have also resulted in exciting findings. Secondary injury mechanisms that promote neuronal cell death and inflammation are being investigated as relevant targets for new drug discovery. Compounds that have been used in other disease conditions or recently discovered novel agents are being tested in clinically relevant models and showing promise for future translation into the clinic. The potential use of pharmacological treatments in combination with temperature management and therapeutic hypothermia strategies represents a fruitful area for continued investigations.