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Home > Research Clinical Trials Initiative Update > Investigational New Drug Approval






Back in 1975 Dr. Richard Bunge had an idea, “to use a person’s own cells to repair damaged spinal cord tissue”. He shared that idea with Drs. Mary Bartlett Bunge and Patrick Wood and together they began a scientific journey. Fast forward 37 years and here we are with United States Food and Drug Administration (FDA) approval to begin testing the safety of injecting Schwann cells into humans with spinal cord injury (SCI). This was not just a journey of three people; it was literally a growing village. For 33 years, multitudes of scientists contributed to building our knowledge of the basic biology of Schwann cells and discovering how they can be utilized to facilitate repair of damaged tissue.


In 2008, we took the first step toward translating Schwann cells from the basic science laboratory to the clinic. We began generating all of the pre-clinical safety and efficacy data to justify the testing of Schwann cell transplantation in humans. This incredible effort was led by Drs. Mary Bartlett Bunge, Dalton Dietrich, James Guest, Allan Levi, Damien Pearse, and Patrick Wood. Dr. Mary Bartlett Bunge spearheaded investigations to evaluate the ability of Schwann cells to repair spinal cord damage in animal models for many years. Dr. Patrick Wood led the Chemistry Manufacturing and Control (CMC) studies to develop a human Schwann cell product manufacturing process. Dr. Damien Pearse took the lead on conducting the pharmacology, toxicology, and tumorigenicity studies in rodent models, while Dr. James Guest did the same with our pig model to develop procedures for safely injecting different doses of Schwann cells into the spinal cord. The team of individuals working in our Animal Core facility, run by Dr. Alex Marcillo, enabled us to take on the massive work load required to generate the extra data to submit to the FDA. Input from Dr. Donna Avison, a university veterinarian who works closely with our researchers, was invaluable during this process. Drs. Allan Levi, James Guest, and Diana Cardenas added their multi-disciplinary clinical expertise to develop the Phase I clinical trial. Mr. Anil Lalwani and Dr. Kim Anderson-Erisman were responsible for pulling all of the different components together for the Investigational New Drug (IND) application. Finally, Dr. Dalton Dietrich, our Scientific Director, assumed responsibility for the entire clinical trial as the Sponsor.


In 2011, that first step was completed when in September 2011 we submitted an IND application to the FDA requesting permission to begin a Phase I clinical trial to evaluate the safety of autologous human Schwann cell transplantation in sub-acute SCI. At that point we began the second step in this process to obtain FDA approval. From October 2011 through July 2012 our team worked with the FDA to answer all questions and clarify all of our data. It was a long process, but by teamwork we were able to achieve success. On July 26, 2012 we had a wonderful conversation with the FDA during which they released us from clinical hold. The second step was complete! Now, we are moving on to the third step, conducting a Phase I clinical trial to determine the safety of transplanting autologous Schwann cell.




 Components currently being translated:

Neuroprotection - Therapeutic hypothermia

Cell replacement - Schwann cell transplantation

Rehabilitation - SCI Boot Camp

Investigational New Drug Process

IND Submission

IND Approval


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