During these unprecedented times of COVID-19 we have fielded many questions about the impact of the pandemic on our clinics, health care systems and patients. I hope everyone has been able to stay safe during these days of isolation and social distancing. While I am confident that a solution to the COVID-19 pandemic will be found, the impact of these events will be felt for years.
Beyond the personal health impacts, economic impacts and changes to our medical system, the pandemic has dramatically impacted basic science and clinical research efforts across the world. The UT Southwestern Q Cell Stem Cell trial is included. Since the mandates to enact social distancing were put into effect, basic science labs and clinical trials were paused. Thus, we have been unable to proceed with our first surgery as planned. Based on the number of questions received, we wanted to provide this update to our community.
We have received FDA clearance to proceed with this phase one trial in paralyzed TM patients. The trial currently plans to enroll nine patients for the surgical implantation of Q Cells. This is a safety study with many regulatory requirements, including a requirement focused on training the surgical team to perform the procedure with novel technology. As we worked during the year to get complete licensing and credentialing requirements for the team, the COVID-19 pandemic began, halting plans for first enrollment and surgery.
Nevertheless, we are preparing to reopen for research at UT Southwestern. As such, we continue to work to identify the nine candidates for this clinical trial. Those interested can find information on the SRNA website. We appreciate your support during these difficult times and remain excited about what lies ahead.
Benjamin M. Greenberg, MD, MHS, FANA, FAAN
Director, Perot Foundation Neurosciences Translational Research Center
O’Donnell Brain Institute
University of Texas Southwestern
Board of Directors, Siegel Rare Neuroimmune Association (Formerly the Transverse Myelitis Association)
Dr. Greenberg has received funding from the SRNA and serves as an unpaid member of the board of the SRNA.