Biography

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 graduatedsumma cum laude在意大利巴勒莫大学的生物科学学院，他还在1999年获得了化学科学博士学位（D.D.R.），并于2001年获得了意大利生物委员会许可证。beplay苹果手机能用吗纽约大学的医学，他在2000年和2002年分别授予了生物医学科学的哲学硕士（M.Phil。）和哲学博士学位（博士学位）。

2003年，Triolo博士加入了意大利巴勒莫匹兹堡医学中心的地中海移植和高级专业疗法（ISMETT）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.

2011年，他加入了休斯敦德克萨斯大学Beplay体育中心健康科学中心（UTHealth），担任儿科外科系的助理教授，临床和转化科学助理教授，以及人类细胞加工CGMP设施的主任。他于2014年被晋升为副教授，并在2019年被任命为克莱尔·格拉斯尔（Clare A.外部干细胞制造机构的可用性和专业知识，以进行基于细胞疗法的临床试验。Triolo博士的主要重点是通过在Uthealth建立符合FDA的生物制造计划来扭转这种趋势。因此，他建立了，进行了操作并指导细胞疗法核心（CTC），该核心由Evelyn H. Griffin干细胞治疗疗法研究实验室和Judith R. Hoffberger Cellular Therapeutics实验室，两个FDA注册的清洁室设施，组织和器官，beplay苹果手机能用吗处理以生产基于细胞的，基于组织的和组合产品，以符合FDA的CGMP。如今，由于CTC，UTHealth拥有一个积极且不断发展的生物制造计划，并具有精致的翻译设施，该设施正在积极制造多个细胞疗法试验。2017年5月，由Triolo博士团队生产的生物人工食管是德克萨斯大学有史以来制造有史以来首次制造的临床级组织工程产品，在世界上首次成功地植入了人类。Triolo博士的最新研究兴趣还包括开发基于成人（beplay苹果手机能用吗例如脂肪）和外交（例如羊水，羊水，沃顿酒店）组织的创新自动组织工程应用。

Education

大学本科
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 Injury

Research Interests

Translational Laboratories

Research Information

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.

Translational Projects

  • Injectable Bio-compatible Gel Composed of induced iPSC derived NSC for Regeneration of BrainTissue (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(与Drs合作。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(与Drs合作。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(与Drs合作。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

  • 治疗严重的成年创伤性脑损伤sing 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(与Drs合作。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.
  • 一项随机，安慰剂对照试验，以评估自体调节T细胞的生物学活性，安全性和耐受性扩展了外部的活体，并静脉内与低剂量的IL-2结合返回肌萎缩性侧向硬化症患者(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.
  • 治疗严重的成年创伤性脑损伤sing 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.