Biography

Fabio Triolo, D.d.R., M.Phil., Ph.D. is an expert in clinical cell therapy manufacturing and has a broad background in clinical-grade cell-based, tissue-based and combination product manufacturing for regenerative medicine applications, as well as extensive experience in compliance with American and European current Good Manufacturing Practices (cGMPs). 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 Scholar 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 (over 7.5 million USD at the time) 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, on behalf of the European Medicines Agency (EMA), and by the Ministry of Education, University and Research, to act as Qualified Person (QP) of Pharmaceutical cGMP facilities authorized to produce biological products for cell therapy, a formal qualification required to obtain production facility authorization by the EMA and to release Advanced Therapy Medicinal Products (Cell Therapy, Gene Therapy and Tissue Engineered Products) for clinical use.

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, named the inaugural holder of the Clare A. Glassell endowed Distinguished Chair in 2019, and promoted to Professor in 2022.  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, The Judith R. Hoffberger Cellular Therapeutics Laboratory, and the Children’s Memorial Hermann Cellular Therapy Lab, three FDA-compliant cleanroom facilities where tissues and organs can be processed to produce cell-based, tissue-based and combination products for clinical applications, in compliance with cGMP of the FDA. The CTC also includes the only clinical flow cytometry laboratory accredited for cellular therapy products in the greater Houston area, and the only cGMP team in the Greater Houston area that operates on a 24/7 basis, 365 days a year, enabling investigators to also carry out cell therapy clinical trials in the acute care setting. Through the CTC, UTHealth has built a vigorous biomanufacturing program with a sophisticated translational facility that actively manufactures for multiple cell therapy trials. To date, clinical grade cell-based products produced and released at UTHealth have been successfully used in hundreds of patients enrolled in clinical trials carried out locally, nationally and internationally, funded by NIH, DOD, CPRIT, disease-focused nonprofit organizations and industry.

Dr. Triolo 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 and/or combination 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. He has over 20 years of experience establishing and directing Investigational New Drug (IND)-dedicated cell production facilities compliant to European and American cGMPs in Europe and in the US, and has supported over 20 cellular therapy clinical trials aimed at adult and pediatric patients, conducted in Europe and in the US based on various cell-based products (e.g., fetal liver progenitor cells, pancreatic islets, bone marrow and umbilical cord derived mononuclear cells, adipose tissue, umbilical cord tissue and bone marrow derived mesenchymal stromal cells, regulatory T cells, genetically modified T cells). Moreover, in collaboration with Biostage/Harvard Apparatus Regenerative Technology, Inc., his team produced a FDA-compliant adipose tissue derived MSC-seeded esophageal implant that was the first tissue engineered esophagus ever implanted in man.

Since 2012, he has been manufacturing cell-based products at UTHealth to support multiple single- and multi-center clinical trials aimed at developing cell-based therapies to improve neurological conditions, such as anoxic brain injury at birth, cerebral palsy, traumatic brain injury, stroke, amyotrophic lateral sclerosis (in collaboration with Houston Methodist), treatment-resistant bipolar disorder (within the first cell therapy trial in the world aimed at a mood disorder) and spina bifida, all of which are still unmet medical needs that have not been able to be satisfied by conventional healthcare therapies.

Education

Undergraduate
University of Palermo, Palermo, Italy
PhD
Chemical Sciences - University of Palermo, Palermo, Italy
M. Phil
Biomedical Sciences - Mount Sinai School of Medicine of New York University, New York, NY
PhD
Biomedical Sciences - Mount Sinai School of Medicine of New York University, New York, NY

Areas of Interest

Clinical Interests

Stem Cell and Regenerative Medicine Applications in Neurological Conditions and Injury

At UTHealth, Dr. Triolo has been 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, stroke, amyotrophic lateral sclerosis (in collaboration with Houston Methodist), treatment-resistant bipolar disorder and spina bifida, all of which are still unmet medical needs that have not been able to be satisfied by conventional healthcare therapies. His 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.

Active Clinical Trials

  • Adjunctive Allogeneic Mesenchymal Stem Cells for Treatment-resistant Bipolar Depression. This Phase 1 randomized, double-blind, placebo-controlled study is aimed at evaluating therapeutic efficacy and tolerability of allogeneic bone marrow-derived mesenchymal stem cells in treatment-resistant bipolar depression patients.
  • A First-in-human (FIH) Study of Inhibitory Interneurons (NRTX-1001) in Drug-Resistant Unilateral Mesial Temporal Lobe Epilepsy (MTLE) (sponsored by Neurona Therapeutics, Inc.). This is a Phase I/II multicenter, open-label, single-arm, FIH, dose escalation study aimed at evaluating the safety and efficacy of inhibitory interneurons (NRTX-1001) for the treatment of drug-resistant unilateral MTLE with mesial temporal sclerosis.
  • A Phase 1/​2 Study of NRTX-1001 Neuronal Cell Therapy in Drug-Resistant Bilateral Mesial Temporal Lobe Epilepsy (MTLE) (sponsored by Neurona Therapeutics, Inc.). This is a multicenter, single arm, open label clinical trial that is designed to test the safety and preliminary efficacy of single administration inhibitory interneurons (NRTX-1001), into both temporal lobes of subjects with drug-resistant bilateral mesial temporal lobe epilepsy.
  • MultiStem for Treatment of Trauma Induced Multiple Organ Failure/Systemic Inflammatory Response Syndrome (MATRICS-1). (sponsored by Healios, Inc.). This is a single center, prospective, randomized, double-blind, pragmatic Phase 2 clinical study aimed at evaluating the safety and efficacy of a bone marrow-derived, allogeneic, multipotent adult progenitor stem cell product (MultiStem) in severely injured trauma patients within hours of hospitalization who have survived initial resuscitation.
  • Safety and Feasibility Study of the CELLSPAN™ Esophageal Implant (CEI) in Patients Requiring Short Segment Esophageal Replacement (sponsored by Harvard Apparatus Regenerative Technology, Inc.). This is a single arm, unblinded, multicenter, prospective first-in-human (FIH) Phase Ib feasibility study to be performed at a maximum of 5 centers in the United States with a maximum of 10 subjects in total. All subjects will receive a CELLSPAN™ adipose tissue derived MSC-seeded esophageal implant and will be followed for a minimum of 2 years post-implant surgery.
  • REcovery with stromal Cells for patient surVivors with A chronic sTrokE (REaCTIVATE). This is a Phase IIa, double-blind, placebo-controlled cross-over trial to assess the safety and potential efficacy of administering human allogeneic bone marrow-derived Mesenchymal Stromal Cells (hBMMSCs) to adults with chronic moderate to severe disability related to stroke.
  • Autologous Adipose derived MSCs for Chronic Traumatic Brain Injury. This is a prospective, randomized, double blind Phase 2 clinical trial, testing the impact of autologous, adipose derived MSC infusion on clinical outcomes and microglial activation in patients with chronic TBI.
  • Autologous Human Umbilical Cord Tissue Patch for Postnatal Closure of Open Neural Tube Defects. In this study, we hypothesized that closure of the dural defect with a patch manufactured from autologous human umbilical cord offers the advantage of not only creating a capacious spinal canal, but may prevent adverse inflammatory responses and restore a more normal meningeal anatomy to the abnormal neural placode and reduction in incidence of tethered cord requiring surgery. 15 neonate patients born with open neural tube defects will be offered closure of the dural defect with a patch manufactured from autologous human umbilical cord. Comparison to historical case data will be the basis for determining the primary outcomes of prevention of radiographic spinal cord tethering and improvements of neurological spinal cord function.
  • ACTengine (sponsored by Immatics US, Inc.). This trial, performed at MD Anderson Cancer Center, Columbia University, University of Pittsburgh, University Hospital Bonn, University Hospital Dresden, University Hospital Würzburg, and soon at the University of Chicago, at 3 Mayo Clinic sites and 2 additional German sites, uses autologous gene-engineered tumor-targeting T cells manufactured at UTHealth, in patients with solid tumors.

Completed Clinical Trials

  • Treatment of Severe Adult Traumatic Brain Injury Using Autologous Bone Marrow Mononuclear Cells. 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.
  • Treatment of Severe Adult Traumatic Brain Injury Using Autologous Bone Marrow Mononuclear Cells. This was a Phase IIB study that assessed 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. 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 was 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 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 (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.
  • MultiStem Administration for Stroke Treatment and Enhanced Recovery Study (MASTERS-2) (sponsored by Athersys, Inc.). This was a Phase 3 study to examine the safety and effectiveness of the bone marrow-derived, allogeneic, multipotent adult progenitor stem cell product MultiStem in adults who have suffered an acute ischemic stroke in the previous 18-36 hours.
  • Double-Blind, Randomized, Placebo-Controlled Phase II Safety and Efficacy Trial of MultiStem in Adults with Ischemic Stroke (sponsored by Athersys, Inc.). This study was aimed at evaluating the safety and potential effectiveness of the bone marrow-derived, allogeneic, multipotent adult progenitor stem cell product MultiStem in adults who have suffered an ischemic stroke.
  • Autologous Cell Therapies for Cerebral Palsy-Chronic (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 Phase II Multi-Site Study of Autologous Cord Blood Cells for Hypoxic Ischemic Encephalopathy (BABYBAC II) (in collaboration with Duke University and sponsored by the Robertson Foundation). This was a multicenter, prospective, randomized, double-blind, placebo-controlled Phase 2 study in which we hypothesized that umbilical cord blood cells would improve the outcome of neonates with neonatal encephalopathy and potentially interrupt the pathophysiologic cascade that is unleashed following hypoxic-ischemic injury.
  • A Study of NCS-01 in Patients with Acute Ischemic Stroke (sponsored by NC Medial Research Inc.). This was an initial Phase I/II dose-finding, double-blind, placebo-controlled, multi-center study to evaluate the safety and tolerability of NCS-01 (a human bone marrow-derived mesenchymal stem cell line) in patients with acute ischemic stroke. All patients were randomized within 24 hours of stroke onset.
  • Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome: A Phase IIb Clinical Trial. (ELPIS II) (sponsored by Longeveron, Inc.). This was a Phase IIb randomized, double-blind study aimed at assessing the efficacy and safety of Lomecel-B, a specialized formulation of allogeneic human MSCs manufactured by Longeveron, as an adjunct therapy to the Stage II palliation for Hypoplastic Left Heart Syndrome surgical intervention.
  • Umbilical Cord Blood Mononuclear Cells for Hypoxic Neurologic Injury in Infants with Congenital Diaphragmatic Hernia. This study evaluated 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 Houston Methodist). This study, carried out at Houston Methodist Hospital and Massachusetts General Hospital, was aimed at evaluating the effect of autologous ex vivo expanded regulatory T-cells on amyotrophic lateral sclerosis disease progression.
  • ACTolog (sponsored by Immatics US, Inc.). This trial, performed at MD Anderson Cancer Center, used autologous endogenous tumor-targeting T cells manufactured at UTHealth, in patients with solid tumors.
  • A Dose Finding Study of CycloSam® (153Sm-DOTMP) to Treat Solid Tumor(s) in the Bone or Metastatic to the Bone (Metastatic Prostate, Breast, and Lung, Osteosarcoma, Ewing’s Sarcoma, and other solid tumor(s) to the bone all eligible). (sponsored by QSAM Therapeutics, Inc.). This was an open-label, unblinded, multi-center, dose-finding study of 153Sm-DOTMP (CycloSam®) to identify the minimum tolerated dose of 153Sm-DOTMP, given as a tandemly administered pair of doses to subjects with solid tumors visible on bone scan.
  • Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (STAT) (in collaboration with University of California, San Francisco). This was a Phase 2b, randomized, double-blind, placebo-controlled, multi-center study to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).
  • First-in-Man Implantation of a Human Adipose-derived MSC Seeded Tissue Engineered Esophageal Implant (in collaboration with Biostage, Inc.).