Normothermic Machine Perfusion (NMP)-Treated Discarded Liver Transplantation: A Multicenter RESTORE trial (mRESTORE)
PI: William Chapman, MD, FACS, Eugene M. Bricker Chair of Surgery, Professor and Chief, Division of General Surgery and Section of Transplant Surgery, Surgical Director, Barnes-Jewish Hospital Transplant Center at Washington University School of Medicine, Executive Vice-Chair, Department of Surgery; Co-PI: Yikyung Park, ScD, Professor, Division of Public Health Sciences, Department of Surgery
mRESTORE is an NIH-funded Phase 2 multicenter (10 sites along with 10 primary Organ Procurement Organizations) clinical trial of transplantation of orphan marginal livers following NMP and objective viability testing (n=97). The primary objective is to demonstrate the safety and feasibility of transplanting NMP-treated marginal livers to patients, which would otherwise have been discarded. The study has significant potential for positive public health impact in increasing transplantable livers and saving lives of patients awaiting liver transplantation.
Dr. William Chapman, an experienced investigator, reached out to Trial-CARE for project management and clinical coordinating center (CCC) services for both the U34 planning grant and U01 clinical trial. Trial-CARE staff are currently facilitating the U34 planning tasks and milestones for the anticipated U01 multi-site clinical trial start-up, through sub-contracting, budgeting, protocol development, MOP creation, Part 11 compliant policies and procedures, eConsent and electronica data capture development and maintenance (e.g., via REDCap Cloud), initial sIRB approval, regulatory file set-up, staff training, site initiations, and all other study start-up tasks.
Trial-CARE shares responsibility for data coordination under the directions of Dr. Yikyung Park, ScD (Co-PI) and Dr. Feng Gao, MD, PhD, MPH, MS as lead faculty biostatistician for the mRESTORE Data Coordinating Center in the Department of Surgery. His responsibilities include study design, safety monitoring, data analysis, and manuscript/abstract preparation.
Trial-CARE staff will continue to provide project management services and CCC services for the duration of the mRESTORE multi-stie clinical trial to assure the quality of data collection, provide ongoing training, study monitoring visits, facilitate acquisition review of MRI data to the central repository/database, facilitate acquisition and reconciliation of biospecimens to the central repository at The Tissue Procurement Center (TPC), submission of required reporting elements, delivery of ongoing training, communication to site staff and regulatory coordinator, budget oversite, and meeting facilitation.
Clincaltrials.gov pending.