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. It is noteworthy that to date, there is no other facility of its kind south of Rome and thus it is considered a major capital asset of Southern Italy. 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. He was promoted to Associate Professor in 2014 and was named the inaugural holder of the Clare A. Glassell endowed Distinguished Chair in 2019. At the time of his recruitment, UTHealth did not have in-house clinical stem cell production capability and was dependent on the availability and expertise of external stem cell manufacturing establishments, in order to carry out cell therapy-based clinical trials. Dr. Triolo was recruited with the primary focus of reversing such trend by establishing a FDA-compliant biomanufacturing program at UTHealth. Accordingly, he established, made operational and directs the Cellular Therapy Core (CTC), which consists of The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory and The Judith R. Hoffberger Cellular Therapeutics Laboratory, two FDA-registered cleanroom facilities where tissues and organs are processed to produce cell-based, tissue-based and combination products for clinical applications in compliance with cGMP of the FDA. Today, thanks to the CTC, UTHealth has an active and growing biomanufacturing program with a sophisticated translational facility that is actively manufacturing for multiple cell therapy trials. In May 2017, a bioartificial esophagus produced by Dr. Triolo’s team, the first clinical grade tissue engineered product ever manufactured at the University of Texas, was successfully implanted in man, for the first time in the world. Dr. Triolo’s most recent research interests also include the development of innovative autologous tissue engineering applications based on adult (e.g., adipose) and extra-embryonic (e.g., Amniotic Fluid, Wharton’s Jelly) tissues.
- 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 Interest
Stem Cell and Regenerative Medicine Applications in Neurological Injury
Research Interests and Medical Missions
Dr. Triolo, an expert in clinical cell therapy manufacturing for regenerative medicine applications, directs the Cellular Therapy Core (CTC) at UTHealth, which consists of The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory and The Judith R. Hoffberger Cellular Therapeutics Laboratory, two FDA-registered cleanroom facilities where tissues and organs are processed to produce cell-based, tissue-based and combination products for clinical applications in compliance with current Good Manufacturing Practices (cGMP) of the FDA. His role functions as a bridge between scientists and clinicians, enabling 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. He also ensures that such processes are designed/translated in compliance with national and/or international regulations according to the nature of the trial. Dr. Triolo is actively involved in several translational and clinical research endeavors of the Program of Regenerative Medicine, including the development of 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. Dr. Triolo’s research interests also include the development of innovative autologous tissue engineering applications based on adult (e.g., adipose) and extra-embryonic (e.g., Amniotic Fluid, Wharton’s Jelly) tissues.
- Injectable Bio-compatible Gel Composed of induced iPSC derived NSC for Regeneration of Brain Tissue (in collaboration with Drs. Charles Cox, Qi Lin Cao, Robert Chin and Fabrico Technology, Inc.). This is a study aimed at developing a directly injectable gel composed of Human induced Pluripotent Stem Cell (iPSC)-derived Neural Stem Cells (NSCs) and porcine brain derived extracellular matrix (ECM).
- Autologous TGFB1 Modified CD34+ Stem Cells for Repair of Diabetic Macular Edema and Macular Ischemia (in collaboration with Drs. Charles Garcia, Stephen Bartelmez and Betastem Therapeutics, Inc.). This is an IND-enabling pre-clinical study aimed at evaluating safety and efficacy of a novel therapeutic strategy to correct dysfunctional diabetic CD34+ cells by transiently modifying CD34+ stem cells derived from patient blood, that both restore perfusion to the ischemic retina and correct vessel leaking.
- Development of an Autologous Wharton’s Jelly-based Therapeutic Strategy for Augmented Repair of Cleft Palate (in collaboration with Drs. Charles Cox and Matthew Greives). This is an IND-enabling project aiming at a first-in-man study focused on evaluating the safety and feasibility of using autologous Wharton’s Jelly to augment the surgical repair of alveolar cleft palate.
- Tools and Technologies for the Harvest/Storage/Deployment of Wharton’s Jelly in Pediatric Craniofacial Surgery (in collaboration with Dr. Charles Cox and Cord Blood Registry, Inc.). This is a project aimed at developing the manufacturing and cryopreservation technology enabling Wharton’s jelly-based Tissue Engineering applications in pediatric craniofacial surgery.
- Development of Human Adipose-derived MSC Seeded Cellspan Esophageal Implant (in collaboration with Drs. Scott Olson, Charles Cox and Biostage, Inc.). Following the successful first-in-man implantation of a tissue engineered esophageal implant manufactured at the University of Texas, this is an IND-enabling project aimed at enabling a Phase I clinical study using clinical-grade tissue engineered esophageal implants.
Active Clinical Trials
- Treatment of Severe Adult Traumatic Brain Injury Using Autologous Bone Marrow Mononuclear Cells (in collaboration with Dr. Charles Cox). This is a Phase IIB study that will assess safety and functional outcomes following treatment of severe TBI in adults using autologous bone marrow mononuclear cells.
- 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.
- A Phase II Multi-site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy (BABYBAC II) (in collaboration with Dr. C. Michael Cotten of Duke University and sponsored by the Robertson Foundation). This is a multicenter, prospective, randomized, double-blind, placebo controlled Phase 2 study in which we hypothesize that umbilical cord blood cells will improve the outcome of neonates with neonatal encephalopathy and potentially interrupt the pathophysiologic cascade that is unleashed following hypoxic-ischemic injury.
- ACTolog (in collaboration with Immatics US, Inc.). This trial, performed at MD Anderson Cancer Center, uses autologous endogenous tumor-targeting T cells manufactured at UTHealth, in patients with solid tumors.
- ACTengine (in collaboration with Immatics US, Inc.). This trial, performed at MD Anderson Cancer Center, uses autologous gene-engineered tumor-targeting T cells manufactured at UTHealth, in patients with solid tumors.
Upcoming Clinical Trials
- SIMFAS – Safety of Intravenous Mesenchymal Stromal Cells for Acute Stroke (in collaboration with Dr. Sean Savitz). This single center, Phase 2 clinical trial will evaluate the effects of early MSC (allogeneic) administration on acute stroke outcomes.
- Administration of Umbilical Cord Blood (UCB) Progenitors for Neurological Injury in Congenital Heart Defects (in collaboration with Dr. Charles Cox). This project will determine if late central nervous system structural outcomes are improved in infants with single ventricle anatomy/physiology following the administration of autologous or allogeneic UCB mononuclear cells compared with patients in a single ventricle registry/historical control group.
- Mesenchymal Stem Cells for Treatment of Acute Respiratory Distress Syndrome (ARDS) Following Trauma (in collaboration with Dr. Laura Moore). This is a placebo-controlled phase 2 clinical trial aimed at testing the efficacy and safety of allogeneic human bone marrow-derived mesenchymal stem cells in patients who develop ARDS following major trauma.
- Adjunctive Autologous Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression (in collaboration with Dr. Jair Soares). This study is aimed at evaluating therapeutic efficacy and tolerability of mesenchymal stem cells in treatment-resistant bipolar depression patients.
- Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants with Congenital Diaphragmatic Hernia (in collaboration with Drs. Matthew Harting and Charles Cox). This study will evaluate the use of autologous umbilical cord blood mononuclear cells to mitigate hypoxic neurologic injury among infants with high-risk congenital diaphragmatic hernia.
- A Randomized, Placebo-Controlled Trial to Evaluate the Biological Activity, Safety, and Tolerability of Autologous Regulatory T-Cells Expanded Ex-Vivo and Returned Intravenously in Combination with Low-Dose IL-2 in People with Amyotrophic Lateral Sclerosis (in collaboration with Dr. Stanley Appel of Houston Methodist). This study is aimed at evaluating the effect of autologous ex vivo expanded regulatory T-cells on amyotrophic lateral sclerosis disease progression.
Completed Clinical Trials
- Double-Blind, Randomized, Placebo-Controlled Phase II Safety and Efficacy Trial of MultiStem in Adults with Ischemic Stroke (in collaboration with Dr. Sean Savitz and sponsored by Athersys, Inc.). This study was aimed at evaluating the safety and potential effectiveness of the adult stem cell investigational product MultiStem, in adults who have suffered an ischemic stroke.
- 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 was aimed at evaluating the safety of acute, intravenous, autologous bone marrow-derived mononuclear cells to treat severe Traumatic Brain Injury in adults.
- Autologous Cell Therapies for Cerebral Palsy-Chronic (in collaboration with Dr. Charles Cox and co-sponsored by Cord Blood Registry, Inc. and Mission Connect). This was 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.
- A Double-Blind, Controlled Phase IIB Study of the Safety and Efficacy of Modified Stem Cells (SB623) in Patients with Chronic Motor Deficit from Ischemic Stroke (in collaboration with Dr. Sean Savitz and sponsored by SanBio, LLC/Sunovion). This was a multicentric double-blind, sham-surgery controlled study aimed at evaluating the clinical efficacy of stereotactic, intracranial injection of SB623 cells (human bone-marrow-derived mesenchymal stromal cells that have been transiently transfected with a plasmid construct encoding the intracellular domain of human Notch-1) in patients with fixed motor deficits from ischemic stroke.