Associate Professor, Program in Regenerative Medicine
Director, cGMP Facilities
Education & Training
- University of Palermo, Palermo, Italy
- Chemical Sciences - University of Palermo, Palermo, Italy
- M. Phil
- Biomedical Sciences - Mount Sinai School of Medicine of New York University, New York, NY
- Biomedical Sciences - Mount Sinai School of Medicine of New York University, New York, NY
Areas of Interests
- Clinical Interests
- Stem Cell and Regenerative Medicine Applications in Neurological Injury
- Research Interest
- Translational Laboratories
Fabio Triolo, D.d.R., M.Phil., Ph.D. is an expert in clinical cell therapy manufacturing, has a broad background in aseptic methods of harvesting, purification, processing, culture, storage and characterization of human cells, and extensive experience in compliance with current Good Manufacturing Practices (cGMP). He graduated summa cum laude in Biological Sciences from the University of Palermo, Italy, where he also completed a Research Doctorate (D.d.R.) in Chemical Sciences in 1999 and obtained the Italian Biological Board License in 2001. From 1996 to 2001 he was a Fulbright Fellow at Mount Sinai School of Medicine of New York University, where he was conferred a Master of Philosophy (M.Phil.) and a Doctor of Philosophy (Ph.D.) in Biomedical Sciences in 2000 and 2002, respectively.
In 2003, Dr. Triolo joined the Mediterranean Institute for Transplantation and Advanced Specialized Therapies (ISMETT) of the University of Pittsburgh Medical Center, in Palermo, Italy where he served as Director of the Experimental Cell Therapy and Cell Transplantation Laboratory until 2011. During his tenure, he established and directed ISMETT’s Office of Research, Health and Biomedical Sciences and designed a state-of-the-art Human Cell Processing cGMP Facility, which was awarded over 6 million euros by the Italian Ministry of Innovation and Technologies in 2005. In 2006 he made the facility operational and was the first person in the Region of Sicily to ever be authorized by the Italian Drug Agency and the Italian Ministry of Education, University and Research, to act as Qualified Person (according to European directive 2001/83/EC) of cGMP facilities authorized to produce cell therapy products.
In 2007, he founded ISMETT’s Regenerative Medicine and Cell Therapy Unit, which he co-directed throughout 2010. Within the unit, he led the human fetal precursor cell isolation and bioreactor group. He also served as Adjunct Assistant Professor of Surgery (2005-2008) and as Affiliate Faculty Member of the McGowan Institute for Regenerative Medicine (2009-2011) of the University of Pittsburgh.
In 2008, he became a member of the National Reference Pole for the Coordination of Biological Resource Centers and Biobanks, nominated by the National Committee for Biosafety, Biotechnology and Life Sciences of the Italian Presidency of the Council of Ministers. He actively participated to the drafting and review of several national guidelines, including the Italian Presidency of the Council of Ministers guidelines for biological banks for infectious diseases, the Italian Presidency of the Council of Ministers guidelines for biobanks and biological resource centers for storage of human samples for research purposes, the Italian Ministry of Health guidelines for procurement, processing, storage and distribution of cells and tissues for clinical use, and the National Transplant Center guidelines for procurement, processing, preservation, storage and distribution of pancreatic islets and hepatocytes. He also served on the task force for Advanced Therapy Medicinal Products (somatic cell therapy, gene therapy and tissue engineering products) of the European Advanced Translational Research InfraStructure in Medicine (EATRIS), aimed at creating a distributed pan-European infrastructure consisting of a network of well-renowned biomedical translation research centers across Europe. Dr. Triolo is a strong advocate of the importance of regulatory requirements and actively contributes to their implementation. For example, he was the first to publish specific risk analysis approaches and procedures applicable to cell therapy manufacturing and to provide a specific model for guidance of cell transplantation centers and cell processing facilities, especially if approaching risk management for the first time.
In 2011, he joined the University of Texas Health Science Center at Houston (UTHealth) as Assistant Professor in the Department of Pediatric Surgery, Assistant Professor of Clinical and Translational Sciences and Director of the Human Cell Processing cGMP Facilities in the Program of Regenerative Medicine and has was promoted to Associate Professor in 2014. At UTHealth, he made operational the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory, an FDA-registered cGMP Facility, and the Judith R. Hoffberger Cellular Therapeutics Translational Laboratory, both of which he directs. He leads the translation, scale-up and validation of promising new therapeutic technologies developed by scientists at a preclinical level, into clinical-grade processes that can be used to manufacture cell-based and/or tissue engineered products for clinical applications. His most recent research interests are focused on the development of innovative fetal tissue engineering therapeutic approaches and cell-based therapies aimed at neurological injury.
Research Interests and Medical Missions
Dr. Triolo, an expert in clinical cell therapy manufacturing for regenerative medicine applications, directs the Judith R. Hoffberger Cellular Therapeutics Laboratory and the Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory within the Program of Regenerative Medicine. The Hoffberger laboratory is focused on translating, scaling-up, validating and supporting IND applications (CMC section) of promising new therapeutic technologies developed by scientists and physicians at a preclinical level into clinical-grade processes that can be used to manufacture cell-based and/or tissue engineered products for clinical applications. The Griffin Laboratory is an FDA-registered facility where tissues and organs are processed to produce cells for clinical applications in compliance with current Good Manufacturing Practice (cGMP).
Stem Cell and Regenerative Medicine Applications in Neurological Injury
Despite dramatic advancements in medical and surgical care, effective clinical therapies for neurological injury are limited. The past decade’s rapid advancement in stem cell biology and neurology has generated a growing body of literature supporting the use of various progenitor cell types to treat acute neurological injuries. In this context, we are actively involved in several research endeavors of the Program of Regenerative Medicine. These include the development of innovative human adult and fetal cell-based therapies to improve neurological conditions, such as anoxic brain injury at birth, cerebral palsy, traumatic brain injury and stroke, all of which are still unmet medical needs that have not been able to be satisfied by conventional healthcare therapies.
• Amniotic Fluid Derived MSCs for Neurological Injury (In collaboration with Drs. Charles Cox and Scott Olson). We have developed a xeno-free method to isolate, expand and cryopreserve clinical-grade human amniotic fluid-derived mesenchymal stromal cells (hAFMSCs) in compliance with cGMP and we are investigating their potential use to treat neurological injury associated with prenatally diagnosed congenital heart disease of infants. This fetal tissue engineering approach is currently being tested in a pre-clinical model with the ultimate goal of using the 15-20 week window between amniotic fluid harvest and birth, to isolate and expand hAFMSCs to treat the affected infant on a predetermined date just prior to, or after birth.
• Development of an Efficient and Safe Cryopreservation Method for the Storage of Clinical-Grade Wharton’s jelly (in collaboration with Dr. Charles Cox). This project aims at investigating the cryopreservation of human MSC-containing Wharton’s jelly for its use in regenerative medicine applications, using xeno-free and serum-free conditions.
• Treatment of Severe Adult Traumatic Brain Injury Using Autologous Bone Marrow Mononuclear Cells (in collaboration with Dr. Charles Cox). This Phase I dose-escalation study is aimed at evaluating the safety of acute, intravenous, autologous bone marrow-derived mononuclear cells to treat severe Traumatic Brain Injury in adults.
• Phase II Trial of Pediatric Autologous Bone Marrow Mononuclear Cells for Severe Traumatic Brain Injury (in collaboration with Dr. Charles Cox). Following the first acute, autologous cell therapy treatment Phase I study for traumatic brain injury in children, successfully completed within the Program of Regenerative Medicine, this study is aimed at evaluating whether bone marrow-derived cells preserve injured brain tissue after traumatic injury in children, and if so, whether such preservation is associated with improvement in functional and cognitive outcomes.
• Autologous Cell Therapies for Cerebral Palsy-Chronic (in collaboration with Dr. Charles Cox and Cord Blood Registry). This is a randomized, blinded, placebo-controlled, cross-over Phase II study designed to compare the effects of autologous bone marrow-derived versus autologous umbilical cord blood-derived mononuclear cells on pediatric patients with cerebral palsy, a group of brain pathologies that result from in utero or perinatal injury to the developing brain, often through stroke, hypoxic insult or hemorrhage and which produce chronic motor disability in children.
• Double-Blind, Randomized, Placebo-Controlled Phase 2 Safety and Efficacy Trial of MultiStem in Adults With Ischemic Stroke (In collaboration with Dr. Sean Savitz and Athersys, Inc.). This study is aimed at evaluating the safety and potential effectiveness of the adult stem cell investigational product, MultiStem, in adults who have suffered an ischemic stroke.