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A First for Spinal Cord Injury

The calls have been coming in. “…Is The Miami Project going to be involved with the embryonic stem cell trial? Where in the United States will this treatment be available? Who will be able to participate?...”  These are some of the questions The Miami Project is getting in response to the announcement that the Food and Drug Administration (FDA) has given first ever clearance for a Phase 1 trial to test the safety of a human embryonic stem cell-based therapy in patients with acute spinal cord injury.


The trial sponsor is Geron Corporation, a biopharmaceutical company based in California. Geron is a world leader in the development of human embryonic stem cell-based therapies and reportedly spent approximately $45 million dollars to prepare its Investigational New Drug application for this important SCI trial.


Geron’s trial will test the safety of human embryonic stem cells in a limited number of acutely injured patients. Since the effects of this type of cell transplantation into the human spinal cord are unknown, it will be critical to rigorously assess the safety and long term risks of the treatment in a well-designed clinical trial. Only through these trials and with continuing basic research in stem cell biology will we understand the promise and limitations of cellular therapies to treat SCI and other human diseases.


Over the last several years, The Miami Project has been following Geron’s progress and some of our investigators have served as advisors to Geron’s research and development team. Clearly, this first U.S. human embryonic stem cell study for spinal cord injured individuals is an important development in the field of regenerative medicine.   


In our opinion, says Dr. W. Dalton Dietrich, “this represents a significant shift in the FDA’s evaluation of the risks and benefits of cell therapies. Importantly, this is a very good thing for The Miami Project’s development of a Schwann cell transplantation trial. We look forward to receiving the same permission from the FDA to start our human Schwann cell trial in not only acute but also chronically injured volunteers.”


Before The Miami Project can submit its own IND application, we must complete FDA-required safety studies. Those studies are underway and The Miami Project is confident, especially in light of recent developments, that the FDA will also give clearance for a future Schwann cell transplant trial. 


Confidence is high because in preclinical studies, adult Schwann cells have been shown to repair the insulation, known as myelin, around nerve cells, and to improve function after SCI in laboratory experiments. Additionally, in contrast to the potential limits of embryonic stem cells, there are several advantages to using adult cells, such as Schwann cells. Adult cells may not be as prone to forming tumors. Another advantage, with Schwann cells in particular, is the cells can be taken from a person’s own body for transplantation into their spinal cord, a treatment approach that may reduce the likelihood of transplant rejection and other unwanted effects.


While Geron’s stem cell transplant will initially be tested only in patients with acute spinal cord injury, The Miami Project intends to examine the safety of Schwann cell transplants in both the acute and chronically injured. Certainly, these are exciting times in the field of SCI research. The Miami Project’s continued hard work to successfully translate exciting laboratory findings to the clinic offers real hope for people living with paralysis.


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