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CORRECTING and REPLACING VirTrial Awarded FDA-Approved Decentralized Clinical Trial with Hope Biosciences

Thursday, October 10, 2019

VirTrial has been awarded an FDA-approved hybrid decentralized clinical trial (DCT) with Hope Biosciences. The study provides Hope Biosciences’ autologous, adipose-derived culture-expanded mesenchymal stem cells (HB-adMSCs) for the treatment of spinal cord injury/disorder (SCI/D). Study protocol incorporates remote visits via VirTrial’s telehealth platform.

“After reviewing countless vendors, we found that VirTrial met our needs as a sponsor and most importantly, patient needs. VirTrial’s partnership in our trial has opened doors for patients who would otherwise be unable to participate due to health and lack of mobility,” stated Donna Chang, President and CEO of Hope Biosciences. “Together, we are able to safely deliver and monitor our therapies for patients in the comfort of their homes. What this means for the world of cell therapy is nothing short of groundbreaking!”

A hybrid decentralized clinical trial eliminates barriers to participation for SCI/D patients who have limited access to travel or suffer from the physical toll travel takes on them. Remote visits limit the demand for all visits to be done in-person. At each remote visit, a registered nurse visits the patient in their home and in conjunction with the physician, who is connected via the telehealth platform, conducts a physical exam. Once the physician gives the approval, the RN can administer the stem cell infusion to the patient in their home.

Mark Hanley, CEO of VirTrial, stated, “VirTrial’s telehealth platform reduces the burden associated with patient participation and makes it possible to recruit patients from a larger geographic area. I applaud progressive sponsors like Hope Biosciences who are embracing virtual trial technology to better serve the patient population and advance the clinical trials industry as a whole.”

Sherry Diers, RN, Clinical Affairs Specialist, Hope Biosciences, commented, “The logistics and the physical toll for patients can be substantial. Using the VirTrial platform makes it possible for Hope to reach across hundreds of miles and deliver treatment.”