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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 laudein 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.

2003年,Triolo加入了地中海Insti博士tute 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.

2007年，他创立了Ismett的再生医学和细胞疗法单位，并在整个2010年共同指导。在该单位内，他领导了人类胎儿前体细胞分离和生物反应器组。他还曾担任外科助理教授（2005-2008），并担任匹兹堡大学麦高万再生医学研究所（2009-2011）的会员教师。

2008年，他成为了由国家生物安全，生物技术和生命科学委员会提名的生物资源中心和生物库协调的国家参考杆成员。他积极参与了几项国家准则的起草和审查，包括意大利委员会主席部长委员会的传染病委员会指南，即感染性疾病的指南，意大利委员会主席生物群岛和生物资源中心的储存人类样品的储存指南出于研究beplay苹果手机能用吗目的，意大利卫生部采购，加工，储存和分布临床使用的细胞和组织以及国家移植中心的采购，加工，保存，存储和分布胰岛和肝细胞的指南。他还曾在欧洲先进的转化研究基础设施（EATRIS）（EATRIS）（EATRIS）的高级治疗药物（体细胞疗法，基因治疗和组织工程产品）任职工作组工作。beplay苹果手机能用吗欧洲著名的生物医学翻译研究中心。beplay苹果手机能用吗Triolo博士强烈倡导监管要求的重要性，并积极地为其实施做出贡献。例如，他是第一个发布适用于细胞疗法制造的特定风险分析方法和程序的人，并为指导细胞移植中心和细胞处理设施提供了特定模型，尤其是在第一次接近风险管理的情况下。

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.

Education

Undergraduate
意大利巴勒莫大学巴勒莫大学
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

翻译实验室

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.

翻译项​​目

  • 可注射的生物兼容凝胶由诱导的IPSC衍生的NSC组成，用于脑的再生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(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.
  • 制定自体沃顿体的基于果冻的治疗策略，以增强left裂的修复(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.
  • 人类脂肪衍生的MSC种子细胞跨食道植入物的开发(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（与查尔斯·考克斯博士合作）。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（与查尔斯·考克斯博士合作）。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,在MD Anderson癌症中心表演,uses autologous gene-engineered tumor-targeting T cells manufactured at UTHealth, in patients with solid tumors.

即将进行的临床试验

  • Sigfas - 静脉内充质基质细胞的安全性急性中风(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（与查尔斯·考克斯博士合作）。该项目将确定与单个心室注册表/历史对照组相比，在自体或同种异体UCB单核细胞进行自体或同种异体UCB单核细胞后，单个心室解剖学/生理学的婴儿是否有改善。
  • 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（与Jair Soares博士合作）.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.
  • 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

  • 多盲的双盲，随机，安慰剂对照的II期安全性和功效试验（与Sean Savitz博士合作，并由Athersys，Inc。赞助）。这项研究旨在评估患有缺血性中风的成年人中成年干细胞研究产品多赛的安全性和潜在有效性。
  • 治疗严重的成年创伤性脑损伤sing Autologous Bone Marrow Mononuclear Cells（与查尔斯·考克斯博士合作）。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（与Charles Cox博士合作，并由Cord Blood Registry，Inc。和Mission Connect共同赞助）。这是一项随机，盲目的，安慰剂对照的，交叉的II期研究，旨在比较自体骨髓衍生的自体脐带血单核细胞对儿科患者脑瘫痪患者的影响，这是一组脑疗法，这是一组脑部病理学。由于子宫或围产期损伤的发生，通常是通过中风，低氧侮辱或出血以及儿童慢性运动障碍而导致的。
  • 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.