ETF Sponsored Research Program Facilities and Resources

The University of Texas Health Science Center at Houston and Children’s Memorial Hermann Hospital provide facilities and other resources to the Principal Investigator and his research team to undertake and complete the proposed research project successfully.

    1. Children’s Memorial Hermann Hospital/Memorial Hermann Hospital-TMC (CMHH/MHH) is the primary hospital for UTHealth.  Children’s Memorial Hermann is a 240-bed acute care hospital with approximately 118 neonatal intensive care beds and 20 pediatric ICU beds. Currently, a dedicated 10-bed pediatric shock-trauma ICU is being built out at CMHH, which will bring the total number of pediatric ICU beds to 30. This tertiary care referral center cares for the most critically ill infants and children in the Texas Medical Center.  The hospital is a major provider of care for the indigent and last year provided $45 million of charity care.  Children’s Memorial Hermann Hospital is the Primary ACS verified Level One trauma center for pediatric patients in Houston (re-verified in 2012-see Appendix) and is the ACS verified burn center for the area. The Children’s hospital also has a Life Flight air ambulance program, which serves over 500 children yearly.  There is a dedicated Neonatal and Pediatric Transport Team staffed with advanced NICU and PICU nursing staff.  The MHH System also includes 11 other acute care facilities in the greater Houston area.  This provides a steady stream of pediatric patients to the children’s hospital and provides a level of stability in patient flow.
    2. The Pediatric Trauma Service is led by Dr. Charles Cox.  It is comprised of 8 attending pediatric surgeons (4 with additional qualifications in Surgical Critical Care), Pediatric Intensivists, Pediatric Neurosurgeons, Pediatric Anesthesiology, Pediatric Orthopaedics, Pediatric ENT, Pediatric Cardiovascular Surgery and Pediatric Emergency Medicine.  An advanced care nurse practitioner team (three NPs) provides inpatient care and participates in all admissions to the Pediatric Trauma Service.  They provide another mechanism for identifying study patients. All pediatric medical sub-specialties are represented. All injured children are admitted to the Pediatric Trauma Service.  Daily patient lists are generated on the CMHH Intranet and screened by the Research Nurse Team as well as the Trauma Program Manager (Tammi Culp, RN).  The trauma registry is maintained by Edmund Diasupil, and data are available for rapid queries in terms of evaluating entry criteria cohorts, audit filters, and data QA processes.
    3. Imaging Capabilities at Children’s Memorial Hermann Hospital
      CMHH has the following MRI capabilities:

      1. General Electric 3Tesla Twin speed, Release 12.0 with a Short Bore
        TwinSpeed Product Data, November 2001
        TRM Maximum Gradient Amplitude:
        Zoom: 40 mT/m in each orthogonal plane
        Whole: 23 mT/m in each orthogonal plane.
        Gradient Rise Time:
        Zoom: 267 Usec to Max Amplitude
        Whole: 287 Usec to Max Amplitude
        TRM Maximum Gradient Slew Rate:
        Zoom: 150 T/m/s
        Whole: 80 T/m/s
        TRM Effective Gradient Amplitude:
        Zoom: 69 mT/m in each orthogonal plane
        Whole: 39 mT/m in each orthogonal plane
        Gradient Type: Non-resonant, actively shielded fast switching dual gradients
        Gradient cooling: Closed loop, circulated water chiller
        Gradient Duty Cycle: 100%
        Coils include advance imaging Coils: Head 8 channel coil, Head and neck 8 channel coil, Torso Body 8 channel coil, Spine CTL with 8 Channels.  High end pulse sequences upon demand; are inflow Time of flight, Fiesta, SSSE, Flair (T1, T2), LAVA 3d, Diffusion weighted, Flouro Triggering, MRA TRICKS, 3d CE MRA, and Diffusion Tensor imaging, Spectrography imaging, Perfusion, Neuro Science Research key for Pedi LMT coil imaging.
      2. Philips Intera 1.5 Achiva Release 2.6 upgraded on June 2010
        Short Bore
        Product magnet Release date Dec 2003 (Gyroscan)NT
        Philips Medical, Netherlands, Europe
        Gradient Strength: 66 mil tesla
        Slew Rate: 180 MT per mil sec.
        Gradient cooling: Glyco heat exchangers
        16 Channel Head coil, 16 channel Head and neck coil. 15 Channel Spine coil. Cardiac coil 32 channel, SENSE body coil 16 channels. Orhto coils (knee, wrist, Ankle 8 channels, Pedi head and neck 8channels, Pedi body coil 8 channels.
        Advance pulse sequence Packages: Cardiac Pro sequences (Pro functional, KTBlast, Delayed Enhancement, Perfusion, SWI VANE, and Coronary imaging).
        Neuro packages (Spectro, diffusion, perfusion, Vista T2 3d, TFE T1 3d, DTI, Fibertraking, CSFlow, inflow MRA/MRV, 3d CE MRA, and 4d CE MRA, Bold packages, Bolus trak. Body 3D Vibe and THRIVE.
      3. Power injectors: Medrad Spectris
      4. MRI Compatible (Dual Monitor) Equipment:
        Precess INVIVO Wireless systems. Expression INVIVO Wireless Monitoring system. (BP, SAO2, ECG wireless, Entidal c02 and all anesthesia Gas monitor on the Fly. (both inside MRI suite and outside MRI suite.
        The MRI department is centrally located within the hospital complex itself and is surrounded by the Children’s Hospital, Heart Center, Transplant, Neuroscience Stroke Center, and Orthopedic department.  Portable monitors accompany our patients, our pediatric anesthesiologists, and MRI nurses from sedation/ Induction rooms to MRI suites and to accompany the return trips to induction rooms post MRI.  General Anesthesia cases are performed on daily basis (4 to 8 cases/day), 7 days a week.  Two Anesthesia teams and two MRI nurses are available daily Mon- Fri in the MRI department and travel to Recovery rooms with cases post MRI in teams for safety. 8 Medrad Pumps are available for all sedation/anesthesia cases needing fluids in MRI suites. Pumps may travel from the Sedation/Induction rooms directly to MRI suites.  Dreager Anesthesia ventilators (1.5 and 3 tesla compatible) are available for use 24 hours a day. Anesthesia techs are available during each case to setup MRI compatible machines in the MRI suites for incoming cases.
        A second Emergency Department MRI is being installed in the Pediatric ED.  The brand and capability are currently in negotiation.
    1. UTHealth Center for Clinical and Translational Sciences (CCTS) is part of the national consortium of medical research institutions, funded through Clinical and Translational Science Awards (the National Center for Research Resources and the NIH), that work together and share a common vision to: 1) improve the conduct of biomedical research across the country, 2) reduce the time it takes for laboratory discoveries to become treatments for patients, 3) engage communities in clinical research, and 4) train a new generation of clinical and translational researchers.  The UTHealth CCTS  acts as a “home” to provide space and resources for faculty and trainees (including the Clinical Research Center), along with expertise in study design, biostatistics, regulatory issues, ethics, bioinformatics, funding of pilot and feasibility studies, provision of resources, protected time for clinical and translational faculty and trainees, and interactions/collaborations with the various communities and industry.  The UTHealth CCTS is very active with approximately 74 investigators and currently 123 ongoing studies, and a 2008-09 budget of over $5 million.
    2. The Clinical Research Center (CRC), a component of the CCTS, is located within the Memorial Hermann Hospital and is an inpatient and outpatient research support service funded by the NIH (Grant UL1 RR024148).  The CRC provides an ideal environment for conducting clinical investigations.  The CRC supports studies outside of the center by using the “scatter bed” concept.  This allows the full support of the CRC for studies conducted in the Pediatric ICU, Shock/Trauma ICU, in the Pediatric Surgery outpatient clinic, or in the CRC itself which has 6 outpatient beds/rooms, and 4 inpatient beds.  A biostatistician is available to help investigators with study, sample size and power estimations, data analysis and related issues.  A full time systems manager is also available to assist with database design and management and software applications.  The center received over $1.8 million in NIH funding for the 2008-09 year.
    3. The Center for Clinical Research and Evidence-Based Medicine, another component of the CCTS, is directed by Jon Tyson, M.D.  A primary goal of this center is to help promote well-designed clinical research in all departments of the Medical School.  The faculty of this Center consists of Dr. Tyson as director; an epidemiologist; a behavioral scientist; a health care economist; a statistician; and two clinicians skilled in clinical epidemiology.  The goal of the Center is to augment population health – as measured by life expectancy without illness or disability – by promoting clinical research of the highest quality and by advancing the way that this research is applied by physicians in caring for their patients.  Medical faculty of the Center collaborate with colleagues in an array of disciplines – epidemiology, economics, ethics, statistics and behavioral and social sciences – to develop innovative programs of research and training.  Within a year of its inception (1998), the Center initiated the Clinical Research Curriculum and Mentorship Program supported by the National Institutes of Health.  This program is a cooperative effort of University of Texas-Houston Medical School and School of Public Health and UT M. D. Anderson Cancer Center to offer in-depth training in clinical research to fellows and faculty within any department.  The research curriculum has since developed into a 2-year, Master’s Degree Program in Clinical Research.
    4. Computers and other equipment – Dr. Cox and the research nurses each have a iMAC and MacBook Pro as well as 2013 Dell computers equipped with Microsoft Office 2010 and all have printers, internet, e-mail and Medline access. They are linked to the Department’s LAN, Memorial Hermann’s Electronic Medical Record System, and the UT Physician’s Clinic Records.  Additionally, the research nurses have a Canon DR-3080 C Scanner and Adobe Creative Suite.  There are also a Departmental copy machine, fax, and laser color printer.  UTHealth maintains a secure network, on which dozens of databases are kept.   If necessary, a non-UT computer could be installed to accommodate the any future study or network data, as has been done for the UTHealth MFMU Network and the Neonatal Network.
    5. Office – The academic offices of the Department of Pediatric Surgery are located on the 5th and 6th floors of McGovern Medical School building.  They are physically connected to Children’s Memorial Hermann Hospital and Memorial Hermann Hospital, are within yards of the CRC.  Dr. Cox and the research nurses have full secretarial support, and the department is equipped with a conference area.  The Pediatric Surgery clinic is in the UT Professional Building located directly across the street from the medical school, and is linked to the school and Memorial Hermann Hospital via a sky bridge.
    1. Developmental Pediatrics and the Children’s Learning Institute:
      The Division of Developmental Pediatrics includes 25 faculty members and is heavily committed to research, with projects currently funded by federal (e.g., NIH, the US Department of Education) and state (Texas Education Agency) agencies, as well as private foundations.  The Children’s Learning Institute (CLI), created within the Division under the direction of Dr. Susan H. Landry, includes researchers from the fields of psychology, neurodevelopment, education, genetics, and child development. The goal of the CLI is to be the pre-eminent source for research and dissemination of proven clinical and educational programs covering early childhood through late teens.
      The CLI is located in the University Center Tower on the 19th, 23rd, and 24th floors and another two floors of a nearby building, with approximately 26,000 sq. ft. of laboratory, office and conference/meeting space. Drs. Ewing-Cobbs, Juranek, Prasad, and Swank are housed in the University Center Tower building. The Division’s 26,000 square feet of workspace sufficiently houses approximately 130 full time faculty, staff, and research assistants. The CLI’s workspace includes five conference rooms, two large training rooms, eight testing rooms for evaluating children, five video play rooms with one-way mirrors and furniture for young children, eight laboratory testing rooms with camcorders for videotaping observational data and 7 coding stations with TV/VCR/DVD for viewing videotaped data, and office space for all faculty, postdoctoral fellows, and staff. There are conference facilities available for satellite and teleconference meetings. Computer equipment is available to research staff and includes multiple computers with a wide of variety of programs for maintaining logs, drafting communications & coding forms, and other research needs.  All research staff has designated office space with telephone and computer/internet access. The office space is adjacent to lab and coding space as well as conference space for project meetings. The University system has an Office of Academic Computing that sustains an environment within the university in which integrated, computational solutions are developed to meet educational, clinical and research requirements.
      The CLI is supported with impressive computing and electronic equipment, including a) microcomputers programmed for observation studies; b) video recorders; c) handheld digital voice recorders; d) a server; and e) numerous software packages for video and audio editing, data management, and statistical analyses (e.g., SAS 9.1, LISREL 8.50, EQS 6.1, MPLUS 4.2, MLWIN 1.2, PARSCALE 4.1, BILOG, SPSS 15, and WINLTA). UTHSC has a fully staffed audio-visual and electronics department that provides set-up and maintenance of all equipment and complete computer resources are available. More impressive is that the Division employs its own IT group and numerous personnel with programming expertise.
    2. Dr. Juranek’s Neuroimaging Lab is housed at the Children’s Learning Institute.  The lab consists of four 64-bit Linux workstations, each computer with dual quad core 2.0GHz processors, 8GB of RAM, and 750GB hard drive. Each Linux workstation has FreeSurfer and FSL installed for image analyses.  Mat lab licenses (including image analysis toolbox) are installed on two of the Linux workstations.  A 2TB Terastation (5 RAID array) provides network attached storage and weekly backups for multi-platform environments (Windows and Linux).
    3. Early childhood, School Age and Adolescent Research Initiatives
      Research is the foundation of the Children’s Learning Institute. A large research database on early childhood has been developed from numerous competitive research grants supported by the National Institute of Child Health and Development (NICHD), National Institute of Neurological Disorders and Stroke (NINDS), the National Institute on Disabilities Rehabilitation and Research (NIDRR), private foundations, and UTHealth. The Data Analysis Work Group (DAWG) is instrumental in the management and analysis of data.  The faculty and staff of DAWG are experts in the design of research studies, development and evaluation of assessment instruments, and statistical analyses including general linear and nonlinear mixed models, structural equation models, and generalized linear models. A recent large NIH program project awarded to CLI has resulted in the development of cutting-edge educational resources in early childhood. Other current initiatives include: The Building Vocabulary for Emergent Readers Curriculum; determining the effectiveness of a school based book exchange program called Raising-A-Reader; and The Texas Pre-kindergarten Limited English Proficiency Pilot Program.  The Institute has extensive experience with assessment and educational interventions for children with limited English proficiency.  The Institute also has a major focus in the area of outcome research in the area of acquired brain injury in children and participates in clinical trials examining cellular therapies to enhance brain repair and plasticity.  Faculty members are also involved in developing innovative intervention strategies to improve the outcomes of young children with brain injuries through parent education and structured intervention in the area of parent-child interaction.
    4. Data Analysis Work Group
      Dr. Paul Swank directs the Data Analysis Work Group (DAWG) of the CLI.  The “DAWGs” are housed in 2000 square feet of office space that includes 15 offices for form development staff, data processing staff, seven master’s degree statisticians, and three doctoral level statisticians.  Data are stored on the University’s NAS server, a dedicated file server for data backup, which has an uninterrupted power supply. This server, with a NetApp Intel® Pentium® 4 processor (2×2.4 GHz) and 12 TB of disk storage, is located in a security zone of the highest level within the University. The DAWGs hold ten Pentium 4 machines at 1.3 to 3.79 GHz, two data entry workstations running Windows XP Professional SP2 with 1GB RAM and 40 Gb hard drives, and four dual processor data analysis computers with 2-4 MB of RAM and 60-100 GB hard drives. The lab also maintains a Lexmark T620 laser printer, a high speed HP 4345mfp laser printer/fax machine/scanner used for mass printing of TELEFORM forms, and a HP 4145 high speed printer. All computers and printers are fully networked. Additionally, all computers and high-speed printers have full 10/100 Mb. connections to the UT network and the Department of Pediatrics LAN, which provide access to additional high speed and color printers, fax machines, and scanners. High-speed connections to the UT fiber backbone and internet facilitate communication among project personnel.
      The DAWGs have developed considerable expertise in database development and management.  These services are further supported through the construction of Basic Script routines, which automate tasks such as score totaling, age calculation, and standard score computation.  These computed fields can be compared to examiner entered fields and discrepancies used to flag variables for human verification.  Through careful design of databases and control systems, we have been able to keep error rates for data entry very low (0.1%) without compromising turnaround time.
    5. The Children’s Learning Institute at the University of Texas Medical School at Houston is home to the following centers, clinics and programs.
      1. Center for Clinical Neurosciences
        The Center for Clinical Neurosciences’ research is central to the mission of the Children’s Learning Institute as it contributes to the enhancement of children’s lives through innovative integration of education, child development, and neuroscience models of cognition that form the backbone of our bench-to-classroom models of assessment and intervention service delivery programs. Of the approximately 20 magnetoencephalography (MEG) labs in North America, CLI’s lab is the only one that has developed the capability to efficiently scan children.
      2. Circle Professional Development Program
        The nationally recognized CIRCLE (Center for Improving the Readiness of Children for Learning and Education) framework, which includes teacher resources and mentoring, was created by CLI. The CIRCLE Professional Development program offers a research-proven, effective curriculum; places mentors in classrooms to help train and guide teachers through the curriculum; gives teachers access to the Web-based Professional Development program; and provides teachers with the ability to monitor the progress of each child.   mCLASS®:CIRCLE delivers the CIRCLE™ suite of observational and assessment tools on a handheld device, Web-based support for classroom planning, and reporting on the mCLASS® handheld technology platform.
      3. Dan L. Duncan Children’s Neurodevelopmental Clinic
        The Dan L. Duncan Children’s Neurodevelopmental Clinic is directed by Linda Ewing-Cobbs, PhD.  Our mission is to enhance children’s opportunities for successful living by providing them with individualized research-based clinical services. A highly unique aspect is our focus on continuing to find the most effective approaches for correcting child developmental and learning problems through a Clinic structure that allows our research to inform the our practices. The Duncan Clinic has 8 offices that have shared clinical and research utilization and are available for assessment of children and parent interviews for the proposed research protocol.
    These facilities will be used for the preclinical UH2 study of JNJ-39393406 to treat inflammation associated with traumatic brain injury in animal models.

    1. Department of Pediatric Surgery Translational Research Laboratory
      1. The Pediatric Surgery Translational Research Laboratory is a 10,000 square foot laboratory cluster that specializes in three major areas and derivative clinical trials.  (1) Progenitor cell therapeutics and tissue engineering, (2) Resuscitation physiology (large animal, small animal, cell models), (3) Medical device development/biohybrid organs, and (4) Phase I clinical trials.  The laboratory expertise focuses on translational issues in preclinical projects and barriers in therapeutic development, regulatory approval processes (IND, HDE, IDE, 510K applications), and the application of these novel approaches for pediatric surgical diseases, trauma and critical care.
      2. MSB 6.622/6.624 (cGMP-Class 100,000-ISO 8 Clean Room)-750sf Hoffberger Cell Therapeutics LabThis is a clinical grade cell and tissue engineering clean room facility with cGMP compliant specifications as listed above. Class 100 biological manufacture can be accomplished in this facility.  Other equipment: Sorva II RC3C Plus ultracentrifuge; Sterigard III, Class II Advance Bio-Safety Cabinets (2); Sanyo Incusafe CO2 Incubators (4); Cobe 2991 Cell Processor; Stainless Steel carts/trays (10)
      3. BBSB 6th Floor (cGMP-Class 10,000-ISO7 Clean Room)-3000 sf Griffin Stem Cell Therapeutics Lab. This is a clinical grade cell and tissue engineering clean room facility with cGMP compliant specifications as listed above.  Class 100 biological manufacture can be accomplished in this facility.  It is currently undergoing validation.
      4. MSB 5.328 (Large Animal Physiology Core)-500sf Siemens 900C mechanical ventilators (2); including ITPV flow apparatus; Sechrist infant ventilator; Drager ventilator;  Sarns 4 head cardiopulmonary bypass pumps with cardioplegia apparatus, including heater/cooler and air supply; Matrix anesthetic vaporizers (3); Cobe cardiovascular perfusion and cardioplegia apparatus; Medtronic sequential a-v pacemaker; Sonometrics digital sonomicrometers interfaced to MacLab analog-digital signal convertor and Gateway Pentium 4 computer; Stoelting isoflurane scavenger; Monostat Jr. cassette pump; Transonic (T-106 and TS 410) transit time flowmeters with 4 probes (R series) and tubing probes; Moor Lab Server-laser Doppler flowmeter linked to Gateway Pentium 3 computer; Millar micropressure transducers; Fisher isotemp and econotemp ovens; Fisher -20 C freezer, Eppendorf 5415D centrifuge; BGE blood gas analyzer; IL-1610 blood gas analyzer; IEC clinical centrifuge; Fisher thermix stirrer; Bethesda Research gradient former; Fully equipped cardiovascular surgery suite with operating instruments and suture/grafts/catheters/cannulae; Olympus fiberoptic bronchoscope; Pelton&Crane autoclave; Ohaus balance; XSI 2300 STAT plus lactate analyzer.
      5. MSE Vivarium Acute Surgical Suite (1)-Assigned to Pediatric Surgery Translational Laboratory-500sf Siemans 300C mechanical ventilator; Edwards Vigilance II continuous cardiac output computer; Nellcor pulse oximeter; ValleyLab electrosurgical generator; iSTAT blood chemistry analyzer; Fully equipped cardiovascular surgery suite with operating instruments and suture/grafts/catheters/cannulae; PICCO cardiac output computer; Microscan microvascular perfusion ultrasound imager;
      6. MSB 5.320 (Rodent Physiology/Operating Suite)-500sfFume hood; Rodent temporary isolated housing with Scientech SL 3000 scale; Rodent operating station with 2 isoflurane vaporizers/scavenger systems and WPI operating microscope and Harvard rodent ventilator/HP 78534 hemodynamic monitor; Columbus Instruments advanced rodent ventilator;  Mettler PE 600 balance, and AE260 deltarange scale;  Fisher isotemp-100 oven, isotemp 210 waterbath, Tecator 1024 shaking water bath; Precision reciprocal shaking bath; Labnet gyrotwister shaker; Orion 420 pH meter; Corning PC-35 hot plate; Corning stirrer; Thermodyne dry bath; Fisher Vortex-Genie; Sci-Cool -20C Freezer; Thermo liquid nitrogen freezer; Licor Odyssey infrared imager with mouse/rat pod anesthesia system; Millar Aria conductance pressure-volume catheter system (PCV-2000; multiple 1-2 French catheters, TC-150 pressure transducer);
      7. MSB 5.316 (Organ Physiology Core)-125 sf Warner Instruments Using chambers linked to Model EC-825 epithelial voltage clamps (6) and Pentium 4 PC; Experimetria isolated, perfused, jacketed organ baths (4) for muscle strip contractility studies with Mac-PowerLab A:D converter linked to Gateway Pentium 4 PC and Techne TE10D circulating water bath; Grass physiologic stimulator and model 7D polygraph recorder; ADInstruments Radnoti (Lagendorf) working, perfused heart system linked to PowerLab 8 channel recorder.
      8. MSB 5.310 (Rodent Incubators)-125 sf
        Awaiting build-out
      9. MSB 5.312 (Tissue processing and Tissue/BioBank)-125sf
        Awaiting build-out
      10. MSB 5.330 (Cold Room)-100 sf
      11. Eppendorf 5414 Microfuge; Wheaton tissue processor; Labnet variable speed rocker.
      12. MSB 5.5.34 (Rodent CCI Core)- 100sf (Neurosurgery) eCCI Model 6.3 controlled cortical impactor (3); Rodent operating station with 2 isoflurane vaporizers/scavenger systems and WPI operating microscope and Harvard rodent ventilator/HP 78534 hemodynamic monitor
      13. MSB 5.512 (Rodent Behavioral Testing)-250 sf (Neurosurgery) Morris water maze tank and video camera (Chromotrack, San Diego Instruments); Rotarod rotating spindle; Balance beam (1.5 cm) and foot fault wire path.
      14. MSE 119 (Cell Core)-250sf Forma Class II sterile biologic hood (3); Thermo Forma Series II CO2 incubators (3); Coulter-Beckman cell counter; Nikon Eclipse inverted digital fluorescent microscope with imaging system and digital camera; Revco -20C freezer; Thermo -196C Liquid Nitrogen cell storage; Thermo -80C Freezer; Thermo 180 water bath; Leica TP 1020 tissue processing station (staining and paraffin block/slide creation) and Leica VT 1000S cryostat; Micron/TBS tissue processing cryostat; Becton-Dickson LSR II Fluorescence Activated Cell Scanner with high throughput capacity sampler; Precision refrigerated centrifuge; Thermo fluorescent plate reader; Amaxa Nucleofector with 96 well high throughput shuttle; Flexcell FX-4000 (tension and compression apparatus) for mechanotransduction/cell force applications; Gyrotary G2 shaker; Corning PC351 hotplate stirrer.
      15. MSB G.100 (Electronics/Laser sintering)- 500sf 3D Systems Sinterstation HiQ selective laser sintering workstation and blaster; BK Precision 4017A 10MHz sweep/function generator;  BK Precision ESR/LER Meter Model 88CTektronix 2245 100 MHz oscilloscope; Extech multimeter; Sinometer HY 30110E DC power supply; ColeParmer Masterflex peristaltic pump; Picza 3D CAD scanner; Agilent 33220A 20mHz waveform generator; BK Precision 2831D RMS Digital multimeter; BK Precision 1689 DC regulated power supply; . Hitachi KP-F120CL CCD Camera (x2) with NI-1429 and NI-1430 Image Acquisition Cards; LabVIEW Vision image processing; Edmund Optical breadboard lab table and hardware.
        MSB 5.004 (CAD/CAM Prototyping)-500sf FlashCut CNC/Minitech CAD milling station with VisualMill, SolidWorks and Rhinoceros software control and interfaced to a Dell Xeon PC; Delta Shopmaster drillpress; Serline 4400 microlathe; Bauer precision tap and die; Servo microdrillpress; -20C freezer/refrigerator.  HP XW 8400 Workstation with LP3065 with plasma screen monitor (3.73 GHz Xeon 5000 dual-core processors; 320 GB HD with TravelStor 8CS SCSI to SATA-II RAID with 2 Terabyte capacity).
      16. MSE 119 (Analytical Core) 750sf discrete of 3000 sf open shared space Harris -80C freezer; Revco -20C freezer (2); LT Air -20C freezer; SCI-Cool -20C freezer; Eppendorf 5415D centrifuge; Eppendorf 5810 refrigerated centrifuge; Nikon 400X microscope and immunohistochemistry supplies; Mastercycler thermal cycler; PTC-100 Peltier thermal cycler; Stovall shaker; Bio-Rad power sources (Power Pac 200 and 300)/EC Apparatus EC135 power source and Fisher gel electrophoresis system; BioRad 16K microcentrifuge; Precision 200R Refrigerated Ultracentrifuge; Molecular Devices kinetic microplate reader interfaced to IBM ThinkPad Pentium 4 laptop with SoftMax Software/printer; Mettler AE 260 balance; PE 600 balance; Scientech SA 80 balance; Scientific Industries Vortex-Genies (2); Pro-250 Tissue grinder; VWR pipettes; Isotemp 202 waterbath; Labnet ET gyrotwister; Labnet 31105 shaker/incubator; Labnet Hermle 233MK2 refrigerated centrifuge; Labnet Accublock digital drybath; Broekel drybath; Fisher Thermix stirrer; Corning PC-353 stirrer; Allied Thermix stirrer; Cimarec Thermal stirrer; Denver Instruments pH meter; Fisher FS 60 sonicator; UVProducts CL-1000 UV crosslinker; Gateway Pentium 4 computers (2); Digi-Doc IT system.
    2. Department of Neurobiology and Anatomy
      The Co-PI’s laboratory is a well-equipped work area for biochemical and molecular analyses that includes equipment such as high and low speed centrifuges, cryostats, ultra-low freezers, plate reader, PCR machines (including a Bio-Rad iCycler real-time PCR machine), water baths, shakers, fume hoods, refrigerators, freezers, sonicator, analytical and preparative balances, pH meters, pipettemen, spectrophotometer, dissecting microscopes, ultra high pressure liquid chromatography (UPLC) system, a BioRad MagPix multiplex ELISA reader, and gel electrophoresis equipment. A Zeiss UV microscope with camera system and software for performing unbiased cell counts (Stereo Investigator) is housed in an access-controlled room near the PI’s laboratory. The laboratories are equipped with 15 Dell computers that are equipped with software packages such as Stereo Investigator, Noldus behavioral analysis software, Gene Spring, LaserGene, GeneTool, Sigma Stat, Adobe CS4, and Sigma Plot.  Three high resolution flat-bed scanners and three networked color printers are available.  The PI has a dedicated rodent surgery room equipped with two electromagnetic cortical impact injury devices, two pneumatic cortical impact devices, two fluid percussion injury devices, a penetrating brain injury device, a PIM3 transcranial Doppler laser scanner, five stereotaxic devices, 10 infusion pumps, seven gas anesthetic setups, bead sterilizer, blood glucose meters, blood pressure monitoring system (both catheter-based, and non-invasive), respirators, DeltaTherm heating pads, three guillotines, and a variety of surgical tools.  The PI holds federal and state licenses for the purchase of all anesthetics/analgesics required for rodent surgery which are housed in a restricted access safe within the laboratory. Micromanipulators, fluorescent plate readers, confocal microscope, cell culture facility, GenePix 4200A slide scanner, phosphoimager, and dark room for developing x-ray film are all available for use.   Behavior rooms are equipped with Morris water maze set-ups including Noldus tracking and analysis software, fear conditioning devices for operant and Pavlovian conditioning, a place avoidance task, object recognition tasks, passive and active avoidance tasks, rotorod, beam balance, and paw placement tasks.
      Laboratories:  Dr. Dash’s laboratory consists of approximately 2,700 square feet of laboratory space within the University of Texas Medical School.  This laboratory space includes three wet laboratories, a dedicated room for aseptic rodent surgery, three behavior rooms, a microscope room, and an animal preparation room for tissue dissection.  The wet laboratories are equipped with all the necessary equipment required to perform the proposed experiments including four Eppendorf microcentrifuges, two cryostats, a Bio-Rad iMark plate reader, a BioRad MagPix multiplex ELISA reader, two conventional PCR machines, a Bio-Rad iCycler real-time PCR machine, water baths (both conventional and shaking), orbital and rocking shakers, two fume hoods, six refrigerators, five -20ºC freezers, a Sonics Vibracell probe sonicator, four analytical and preparative balances, three SymPHony pH meters, numerous Gilson and Eppendorf pipetman, a Beckman Coulter spectrophotometer, two Zeiss dissecting microscopes, a Shimadzu Nextera ultra high pressure liquid chromatography (UPLC) system, and 2-D and 1-D gel electrophoresis equipment.  Three dedicated behavior rooms within the laboratory of Dr. Dash are available for use.  Two of these rooms were designed for carrying out water maze experiments and contain water mazes, digital cameras, dedicated computers running Noldus tracking and data analysis software, infusion pumps and warming chambers.  Each room contains distinct extra maze cues and has a unique shape, allowing the same animals to be tested in the different rooms.  In addition, two T-mazes, specifically designed for use in the water maze, are available.  The third behavior room is designed for testing fear-related memories and contains a operant fear conditioning task that is fully programmable to carry out delay fear, trace fear and contextual discrimination tasks; a place avoidance task with tracking camera, rotating arena, and analysis software; and a passive and active avoidance task.  In addition, equipment for testing motor function including the beam balance task, two paw placement tasks, and a rotorod task are available and can be used within any of the behavior rooms.  The dedicated surgery room is access controlled with surveillance camera and entry logs.  The surgery room contains three cortical impact devices (two electromagnetic and one pneumatic), two fluid percussion injury devices, and a penetrating brain injury device.  The surgery room contains all the equipment required for performing brain injury and infusions including anesthesia devices, isoflurane scrubbers, surgical tools, bead sterilizers, stereotaxic frames and arms, fume hood, warming chambers and temperature regulators. A dedicated microscope room containing a Zeiss Axiovert microscope with brightfield and epifluorescence capabilities is available.  This microscope contains a motorized X-Y stage connected to a computer for carrying out sterological cell counts and photography.  The computer is loaded with imaging software as well as StereoInvestigator.  The prep room contains three guillotines, perfusion pumps, anesthesia hood, and a CO2 chamber.  Outside of the laboratory space is a common equipment room containing two -80ºC freezers exclusively for use by the members of Dr. Dash’s laboratory, a ultra-high speed centrifuge, a Zeiss confocal microscope, a GE Lifesciences Typhoon Trio Plus imager,  and a scintillation counter.
      Animal: All experimental animals are housed within the newly constructed vivarium that is part of the Medical School Extension, a 6-story building physically attached to the Medical School.  Access to the vivarium is restricted to those personnel listed on an approved Animal Welfare Committee protocol, and regulated by key card access. This facility is overseen by the Department of Laboratory Medicine and Animal Care and has AAALAC approval.  Animal Care is under the direction of Dr. Bradley Goodwin, DVM and regularly inspected by the Food and Drug Administration.  Animals are maintained on a standard 12hr dark-light cycle with free access to food and water.  Dr. Thomas Gomez, DVM is in charge of inspecting and maintaining the rodent housing facility.
      Computer:  Our laboratories and offices contain 15 Dell desktop computers, three Hewlett Packard color laser Jet printers, and three flatbed scanners for use by the personnel in Dr. Dash’s laboratory.  In addition, five Dell desktop computers and one Dell laptop computer are attached to laboratory equipment for running the real-time PCR device, behavioral equipment, and microscope.  All computers are loaded with data analysis software including SigmaPlot, SigmaStat, and Excel, as well as software for manuscript preparation such as Microsoft Word, Microsoft PowerPoint, Adobe Illustrator, Adobe Photoshop, and Reference Manager.  In addition, remote licenses for Noldus, GeneSpring, LaserGene, and GeneTool are available.  An off-site server with tape back-up and mirror site is accessible via password for long-term storage of data.  VAX and IBM mainframes are available through the Texas University Health Science Center at Houston.
      Clinical:  The Co-PI has access to a laboratory space exclusively for use in the preparation and storage of clinical samples.  This room has a work bench, two refrigerated centrifuges, biohazard waste disposal, and two -80ºC freezers exclusively for the storage of human samples.  These freezers are maintained behind a locked door, and are themselves locked with a padlock.  The temperature of the freezer is continuously monitored and recorded.  All samples are logged in and out by an authorized representative of the Neuroscience Research Repository.
    3. Research Team Offices: Department of Pediatric Surgery
      1. MSB 5.236 (Cox), 120 sf: iMAC tower and MacBookPro with HP color laser printer; copier/FAX and high speed internet access.
      2. MSE 5.233 (Olson), 120 sf: Dell OptiPlex 780 Core i5 with HP LaserJet printer; Fujitsu ScanSnap scanner; copier/FAX and high speed internet access.
      3. MSB 5.324 (Kosmach/Jimenez), 200 sf: Clinical Research Nursing Administrative Core Offices: Dell Dimension 8100 Pentium 4 PC with HP color laser printer; copier/FAX and high speed internet access; Canon DI 3080 high volume scanner; Minolta Di-Image Elite II scanner.  These offices contain locking file cabinets for secure storage of HIPPA protected patient data.
      4. MSB 4.266 (Gill), 120 sf: Dell Dimension 8100 Pentium 4 PC with HP color laser printer; copier/FAX and high speed internet access.
      5. MSB 5.234 (Benjy Brooks Conference Room), 250 sf: 14 person conference room with 70″ SMART Board, Dell  computer with internet access.
      6. CMHH 11 (Culp), 100sf: Dell Dimension 8100 Pentium 4 PC with network printer; Network access to CMHH trauma data base and NTDB.
      7. MSB 5.230 (Willingham), 100sf: Research Coordinator: Dell network printer and Fujitsu ScanSnap scanner.
      8. MSE 123 (Post doctoral fellow offices), 200 sf:  3 spaces assigned to lab. High-speed data links/printers, scanner and secure data storage.
      9. BBSB (GMP facility director and technician offices), 750sf: The office suite is comprised of one private office and a larger, 4-cubicle open area for technician work areas.  High speed data and voice links are at each station.
    4. Department of Neurobiology and Anatomy Office:
      The Co-PI has 130 sq. ft. of office space in the Department of Neurobiology and Anatomy, The University of Texas Medical School.  The PI has access controlled desktop computers and printers within their respective offices.  An expandable server with controlled access is available for data backup.  Information on this server is subjected to routine tape back-up and is mirrored on an off-site location outside of Houston
    5. Other facilities: Department of Pediatric Surgery
      1. The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory
        The Evelyn H. Griffin Stem Cell Therapeutics Research Laboratory is a brand new state-of-the-art Class 10,000 (ISO 7) Human Cell Processing cGMP Facility. It comprises a 3,000 sq. ft suite of clean-room laboratories engineered to comply with, and to exceed, current Good Manufacturing Practice (cGMP) and Good Tissue Practice (GTP) requirements. The facility includes 3 core cell processing lab suites able to independently perform cGMP-grade cell manipulations that allow large-volume throughput. Each core laboratory has its own entrance and its own exit to ensure a unidirectional flow of personnel. The functioning of the facility is managed by a sophisticated computerized control system interfaced with an advanced environmental monitoring system equipped with particle counters, pressure, temperature and humidity sensors) and with an instrumental monitoring system that allows continuous monitoring of the performance of critical equipment (e.g., incubators, refrigerators and freezers). The facility is locked with an adequate control of entry and exit from the processing areas (access control and door interlock system) to maintain isolation and cleanliness for aseptic processing and to guarantee that only authorized and trained personnel access the facility. An access control management system was installed in full compliance with project specifications and avails itself of a controller that manages staff transit through project-defined passageways by means of a “transponder” ID badge recognition system. An integrated door interlock system interfaces with the access control and management system, to prevent unwanted door opening sequences that may affect the balance among the differential pressures set in the various areas. These devices, alike the telephone systems in each processing suite, are all completely wall-mounted, particularly suitable for the specific premises. The facility also comprises 1,000 sq. ft. of office space equipped with FAX machines, scanners, e-mail, voice-mail, computers and assorted small office equipment. Its activity supports the UTHealth Program in Regenerative Medicine and its clinical cell transplantation activity by producing clinical grade cellular products derived from bone marrow, peripheral and umbilical cord blood. The Facility is exclusively used for human cell and tissue processing and its mission is to provide innovative clinical-grade cell products and advanced therapies with the adequate quality for the intended use in humans. In addition to preparing cells to be transplanted in-house, the facility also provides distant cell processing services, allowing remote transplant centers lacking an onsite cell processing lab, to perform cellular transplants. In addition to the preparation and distribution of high quality cells to be used for transplantation or research purposes, the facility serves as a teletraining center through the use of advanced portable telepresence systems, which also allow laboratory staff to obtain remote consultations in real time, from experts located anywhere in the world.
      2. BBSB (cGMP-Class 10,000-ISO7 Clean Room)-3000 sqft Griffin Stem Cell Therapeutics Lab: FDA Establishment Identifier: 3009561521
      3. NuAireLabgardClass II Type A2 Biological Safety Cabinet (6); Thermo Scientific Sorvall RC3BP Plus low-speed centrifuge equipped with H-6000A swinging bucket rotor (1); Thermo Scientific Sorvall RC4 low-speed centrifuge equipped with LH-4000 swinging bucket rotor (2); BiosafeSepax 2-RM Automated Cell Processing System for Regenerative Medicine applications (2); Sorvall Olympus CKX41 Inverted Microscope (3); Thermo Scientific CryoMed TF7452 Controlled-Rate Freezer (1); MVE model 819P-190F-GB Liquid Nitrogen Vapor Freezer (2); Thermo Scientific Revco under counter refrigerator model REL404A with stainless steel interior (3); Thermo Scientific Revco under counter freezer model ULT430A with stainless steel interior (3); Thermo Scientific Revco refrigerator model REL-3004A (1); Thermo Scientific Revco refrigerator model REL-5004A (1); Thermo Scientific Revco High-Performance -20ºC Laboratory Freezer model UGL2320A (2); Thermo Scientific Forma Ultra-Low Temperature -86ºC Laboratory Freezer model 8690 with Liquid Nitrogen Backup System (1); Thermo Scientific Forma Ultra-Low Temperature -86ºC Laboratory Freezer model 8692 with Liquid Nitrogen Backup System (1); Thermo Scientific Forma 3140 water jacketed tri-gas incubator equipped with IR CO2 sensor, internal HEPA filter, copper interior, chamber cooling coil and eight independent inner door glass assembly (6); CISCO TANDBERG new generation portable telepresence CPS system in dual-monitor, wireless, full HD configuration (1)
    6. Department of Neurobiology and Anatomy
      Other facilities: Cold room, autoclave and dishwasher facilities, several common equipment rooms, molecular core and EM facility are available for use.  UTHSC-H core laboratories and resources allow broad access to state-of-the-art technologies, sample and data collections, informatics tools and scientific consultation in order to facilitate interactions between researchers and to enhance scientific productivity. Access to Core Facilities is open to all researchers at the University of Texas Medical School.  Core facilities include Multi-User Fluorescence Imaging and Microscopy Core Facility, EPR (Electron Paramagnetic Resonance), High Throughput Microscopy/High Throughput Compound Screening Core Laboratory, Biomarker Core Facility, IMM Flow Cytometry Core Laboratory, and a Proteomics Core Laboratory.
      Scientific Environment:
      The University of Texas Health Science Center (UTHealth) has a long history of medical and research excellence, and is the most comprehensive academic health center in The UT System and the U.S. Gulf Coast region.  UTHealth is home to the schools of biomedical informatics, biomedical sciences, dentistry, medicine, nursing, and public health, and employs more than 10,000 research and health professionals. UTHealth educates more healthcare professionals than any health-related institution in the State of Texas and features the nation’s seventh-largest medical school. It also includes a psychiatric hospital and a growing network of clinics throughout the region. The university’s primary teaching hospitals include Memorial Hermann Hospital-Texas Medical Center, Children’s Memorial Hermann Hospital and Lyndon B. Johnson General Hospital.  The researchers at UTHealth have secured more than 220 NIH grants, as well as grants from the Department of Defense and numerous private foundations.  The Departments of Neurobiology and Anatomy, and Neurosurgery have a combined total of 43 research faculty that provide expertise covering many areas of neuroscience including computation neuroscience, behavioral neuroscience, molecular neuroscience, and neurotrauma.  The members of these departments routinely collaborate with one another, attend symposia and seminars, host journal club meetings, and are available for consultation as needed.  In addition, Dr. Dash is a member of Mission Connect, a collaborative research group consisting of researchers from Baylor College of Medicine, UTHealth, the University of Texas Medical Branch in Galveston, Texas A&M University, Rice University, the University of Houston, and several affiliated hospitals.  These researchers attend monthly meetings where current and future research aimed at finding a cure for brain and spinal cord injury is discussed.

FDA Clinical Hold Letter

UCB Processing SOP

FDA IND Submission