Coordinating Center for Clinical Trials

Advancing public health science by providing comprehensive trial coordination for small and large multicenter studies.

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About the Coordinating Center for Clinical Trials


The Coordinating Center for Clinical Trials (CCCT) provides full-service trial coordination for research studies. We handle the logistical and statistical challenges of coordinating small and large multicenter studies and research projects, allowing Investigators to focus on their patient-participants. Our expert team collaborates with investigators every step of the way – from study design and execution to the dissemination of trial findings. We invite you to learn more about our services, our team, and who we can expand your research, streamline your data collection, and manage the operations integral to your project.

Who we are

The UTHealth Coordinating Center for Clinical Trials (CCCT) has an established history of advancing science through coordinating clinical trials. Since our inception in 1971, the CCCT has served as a coordinating center for more than 25 nationwide multicenter clinical trials. Our expertise spans l research areas including biostatistics, epidemiology, clinical trials, data management, trial design, data science, computer science, bioinformatics, and genomics. The mission of the CCCT is to improve a broad spectrum of public health interests through the coordination of clinical trials, collaboration with clinical investigators, and the development of statistical and trial methodology.

Clinical trials are undergoing a revolution in the era of big data. Here at the CCCT, we have the capacity to undertake multifaceted clinical trials using complex and high-dimensional data gathered from sources including wearable devices and electronic medical records. Leveraging data that’s collected automatically or as part of the patient standard of care, allows for clinical trials that are more efficient and less costly to design.

Research interests

The CCCT has the capability and expertise to work on many topics of medical and public health interests.

Areas of expertise

  • Cardiovascular
  • Diabetes
  • Kidney disease
  • Stroke
  • Sickle cell
  • Ophthalmology
  • Cell Therapy
  • Trauma
  • Rheumatology
  • Neurology
  • Dental
  • Psychiatry
  • Gastroenterology
  • Pulmonary
  • Pharmacokinetics

Innovative interventions

  • Diet-drug trials
  • Community-based clinics
  • Dissemination of trial results
  • Wearable device trials
  • Smartphone-based intervention to reduce recidivism
  • Strategies for recruitment of racial and ethnic diverse groups in clinical trials
  • Randomized trial for an intervention to decrease sedentary behavior

Clinical trial methodology

  • Factorial design
  • Bayesian adaptive design
  • Adaptive randomization, seamless trial
  • Group sequential monitoring 

Services offered by the CCCT

50 years of successfully providing comprehensive services and coordinating large multi-center clinical trials

Although our primary goal is to design large multicenter clinical trials, we also work on smaller single-site trials. Regardless of trial size and complexity, we provide high-quality study design, monitoring, management, reporting, and interpretation of study findings.

Our model (below) highlights our capabilities and can be scaled to fit the needs of a given research project. Take a look at what we can do for you.

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First hour: free of charge


Free for collaboration on the grant application, but the service provider and his/her associates’ effort and other needs for the proposed project should be appropriately budgeted in the grant application.

We recommend

  • For a large program or center grant, usually, 10-20% of the overall project budget is suggested for data management, modeling, and analysis, which depends on the size and complexity of collected data from the project.
  • For smaller, multicenter (two or more) projects, we are happy to meet with you to discuss the project and provide a quote for services that meet the needs of the trial.

Trials and projects

Antihypertensive and Lipid Lowering Treatment to Prevent Heart Attack Trial (ALLHAT)

Read about ALLHAT here

Ancillary Study - Sustained Blood Pressure Control and Progression of Multimorbidity in ALLHAT NHLBI R01 (Subcontract from Duke University. 2016-2020. ($316,284).

Ancillary Study. Long-term Benefits & Harms of Antihypertensive Drugs in the Elderly: Up to 22-year Follow-Up of ALLHAT Trial Participants. Xainglin Du, PI. NIA. 2018-2022 ($1,324,000).

Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome:  A Phase IIb Clinical Trial (ELPIS II)

The ELPIS II trial is being conducted by a consortium of clinical centers in the US who routinely direct surgical and follow up care for children with hypoplastic left heart syndrome (HLHS). The  trial is testing whether Lomecel-B (containing human mesenchymal stem cells) is safe and effective in treating patients with HLHS when administered during the child’s second staged palliative surgery.

Sponsored by the National Heart, Lung and Blood Institute (NHLBI); 2020-2025 ($1,862,493).

A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Transendocardial Injection of Allogeneic-MSC versus Placebo in Patients with Non-Ischemic Dilated Cardiomyopathy (DCM II)

The purpose of the DCM II study is to determine whether giving allogeneic mesenchymal stem cells to patients with heart muscle damage is safe and whether this improves heart function.  Additionally, this study will examine whether an individual’s genetics plays a role in determining his/her response to the cell therapy.  Four US clinical centers are participating.

Sponsored by the US Department of Defense; 2020-2024 ($4,778,129).

Cardiovascular Cell Therapy Research Network (CCTRN) Data Coordinating Center

The CCTRN is a cooperative clinical network consisting of seven clinical centers in the United States dedicated to studying stem cell therapy for the treatment of cardiovascular and peripheral arterial disease. The Network includes expert researchers with experience in cardiovascular and peripheral vascular care at seven stem cell centers in the United States. CCTRN is currently planning and conducting multicenter study phase II clinical trials.

Sponsored by the National Heart, Lung and Blood Institute (NHLBI; -Cooperative Agreement-2UM1HL087318-06); 2012-2021 ($63,000,000).

Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome (CHILD)

The CHILD study is assessing the safety, feasibility, and efficacy of intramyocardial delivery of c-kit+ cells in patients with hypoplastic left heart syndrome under 6 months of age.

Sponsored by the Marcus Foundation Inc.; 2019-2021 ($609,279).

Phase III, multicenter, prospective cluster-randomized comparative effectiveness study in tPA-eligible patients (patients with ischemic stroke)

The primary goal of this project is to carry out a trial comparing pre-hospital diagnosis and treatment of patients with stroke symptoms using a Mobile Stroke Unit (MSU) with subsequent transfer to a Comprehensive Stroke Center (CSC) Emergency Department (ED) for further management, to standard pre-hospital triage and transport by Emergency Medical Services (EMS) to a CSC ED for evaluation and treatment (Standard Management-SM).

Sponsored by: Memorial Hermann Health System; 2014-2022 ($2,336,999).

Recent publications 

Rahimi K, Canoy D, Nazarzadeh M,  Salimi-Khorshidi G, Woodward M, Teo K, Davis BR, Chalmers J, Pepine CJ on behalf of the Blood Pressure Lowering Treatment Trialists’ Collaboration. Investigating the stratified efficacy and safety of pharmacological blood pressure-lowering: an overall protocol for individual patient-level data meta-analyses of over 300 000 randomised participants in the new phase of the Blood Pressure Lowering Treatment Trialists’ Collaboration (BPLTTC). BMJ Open 2019;9:e028698. doi:10.1136/bmjopen-2018-028698

Johnson K, Oparil S, Davis BR, Tereshchenko LG. Prevention of Heart Failure in Hypertension-Disentangling the Role of Evolving Left Ventricular Hypertrophy and Blood Pressure Lowering: The ALLHAT Study. J Am Heart Assoc. 2019 Apr 16;8(8):e011961. doi: 10.1161/JAHA.119.011961.

Bowling CB, Davis BR, Luciano A, Simpson LM, et al. Sustained blood pressure control and coronary heart disease, stroke, heart failure, and mortality: An observational analysis of ALLHAT. J Clin Hypertens (Greenwich). 2019 Apr;21(4):451-459. doi: 10.1111/jch.13515. Epub 2019 Mar 13.

Kostis WJ, Sargsyan D, Mekkaoui C, Moreyra AE, et al. Association of orthostatic hypertension with mortality in the Systolic Hypertension in the Elderly Program. J Hum Hypertens. 2019 Feb 25. doi: 10.1038/s41371-019-0180-4. [Epub ahead of print]

Berkelmans GFN, Gudbjörnsdottir S, Visseren FLJ, et al. Prediction of individual life-years gained without cardiovascular events from lipid, blood pressure, glucose, and aspirin treatment based on data of more than 500 000 patients with Type 2 diabetes mellitus.

Eur Heart J. 2019 Jan 9.

Barzilay JI, Lai D, Davis BR, Pressel S, Previn HE, Arnett DK. The Interaction of a Diabetes Gene Risk Score With 3 Different Antihypertensive Medications for Incident Glucose-level Elevation. Am J Hypertens. 2019 Mar 16;32(4):343-349.

Pennells L, Kaptoge S, Wood A, …Emerging Risk Factors Collaboration. Eur Heart J. 2019 Feb 14;40(7):621-631. doi: 10.1093/eurheartj/ehy653. Equalization of four cardiovascular risk algorithms after systematic recalibration: individual-participant meta-analysis of 86 prospective studies.

Haywood LJ, Davis BR, Piller LB, et al. Risk Factors Influencing Outcomes of Atrial Fibrillation in ALLHAT. J Natl Med Assoc. 2018 Aug;110(4):343-351.

Barzilay JI, Davis BR, Ghosh A, et al. Rapid eGFR change as a determinant of cardiovascular and renal disease outcomes and of mortality in hypertensive adults with and without type 2 diabetes. J Diabetes Complications. 2018 Sep;32(9):830-832.

Karmali KN, Lloyd-Jones DM, van der Leeuw J, et al. Blood pressure-lowering treatment strategies based on cardiovascular risk versus blood pressure: A meta-analysis of individual participant data. PLoS Med. 2018 Mar 20;15(3):e1002538.

Barzilay JI, Davis BR, Pressel SL, et al. The Effects of eGFR Change on CVD, Renal, and Mortality Outcomes in a Hypertensive Cohort Treated With 3 Different Antihypertensive Medications.  Am J Hypertens. 2018 Apr 13;31(5):609-614.

Joseph Cosico, Jennifer Chambers, Rachel Olson, et al. Training Clinical Research Coordinators of the Cardiovascular Cell Therapy Research Network (CCTRN) Using an Online Learning Platform. Clinical Researcher. Jan 2018:32(1). DOI:10.14524/CR-17-0024. PMCID: N/A

Jay H. Traverse, Timothy D. Henry, Carl J. Pepine, et al. TIME Trial - Effect of Timing of Stem Cell Delivery Following ST-Elevation Myocardial Infarction on the Recovery of Global and Regional Left Ventricular Function: Final 2-Year Analysis. Circ Res. Feb 2018;122:479-488. PMCID: PMC5805626.

Roberto Bolli, Joshua M. Hare, Keith L. March, et al. Rationale and Design of the CONCERT-HF (Combination Of meseNchymal and c-kit+ Cardiac stEm cells as Regenerative Therapy for Heart Failure) Trial. Circ Res. June 2018;122:1703-1715. PMCID: PMC5993622.

Shelly L. Sayre, Judy Bettencourt, Michelle Cohen, et al. Expectations of Cell Therapy: An Evaluation of the Cardiovascular Cell Therapy Research Network (CCTRN) Patients with Intermittent Claudication Injected with ALDH Bright Cells (PACE) Trial. Clinical Researcher. May 2018;32(5).DOI: 10.14524/CR-17-0041.

Roberto Bolli, Joshua M. Hare, Timothy D. Henry, et al. Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial. Am Heart J. July 2018;201:54-62. PMCID: in progress.

Contact us

Interested in collaborating?

The University of Texas Health Science Center
School of Public Health
1200 Herman Pressler, 8th and 9th Floor
Houston, Texas 77030

Phone: 713-500-9529
FAX: 713-486-0981
Email: shelly.l.sayre@uth.tmc.edu 

  • DCM-II Trial

    A Phase IIB Randomized, Placebo-Controlled, Multicenter Study of the Comparative Efficacy and Safety of Transendocardial Injection of Allogeneic-MSC versus Placebo in Patients with Non-Ischemic Dilated Cardiomyopathy.

    This research study is being conducted to determine whether giving allo hMSCs to patients with heart muscle damage is safe. We will also examine whether this study drug improves heart function and if an individual’s genotype (genetics) plays a role in determining his/her response to allo hMSC therapy.


    Image sourced from Canva
  • ELPIS II Trial

    Evaluation of Lomecel-B™ Injection in Patients with Hypoplastic Left Heart Syndrome.

    The purpose of this study is to test whether Lomecel-B works in treating patients with HLHS and to gather additional information about the safety of Lomecel-B. Lomecel-B contains human mesenchymal stem cells (MSCs) as the active ingredient.


    Image sourced from Canva
  • CHILD Trial

    Autologous Cardiac Stem Cell Injection in Patients with Hypoplastic Left Heart Syndrome: An Open Label Pilot Study

    This study aims to test how safe and effective autologous ckit+ cell therapy is for managing hypoplastic left heart syndrome. It is hoped that by injecting these stem cells into the right ventricle of the heart, that there will be better right heart pumping function as the child gets older. 


    Image sourced from Canva