Abstract

Cellular Processing Core (CPC) The CPC has been established to provide the rapid and safe transition of basic research ideas to clinical practice. Some of the preclinical tasks include the qualification and testing of reagents, scale-up of methods, development of Standard Operating Procedures (SOPs), ongoing process validation, the provision of a controlled good tissue practice GTP infrastructure and support for compiling investigational New Drug (IND) applications. The CPC will support Projects 1 and 3 in the translation of the research studies proposed in these projects to clinical trials. This is a rate limiting step at many Institutes and by centralizing this function in the Core; these studies will undergo pre clinical development and scale up in an optimal fashion. The personnel in the CPC will assist the PIs of Projects 1 and 3 in submitting an IND to conduct the clinical trials, will provide QA/QC assistance and will generate SOPs and worksheets to ensure compliance with regulatory agents in the conduct of the clinical studies.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Specialized Center--Cooperative Agreements (U54)
Project #
5U54HL081028-02
Application #
7312650
Study Section
Special Emphasis Panel (ZHL1)
Project Start
Project End
Budget Start
2006-09-01
Budget End
2007-08-31
Support Year
2
Fiscal Year
2006
Total Cost
$300,781
Indirect Cost

  Institution

Name
Johns Hopkins University
Department
Type
DUNS #
001910777
City
Baltimore
State
MD
Country
United States
Zip Code
21218

  Publications

Ramireddy, Archana; Brodt, Chad R; Mendizabal, Adam M et al. (2017) Effects of Transendocardial Stem Cell Injection on Ventricular Proarrhythmia in Patients with Ischemic Cardiomyopathy: Results from the POSEIDON and TAC-HFT Trials. Stem Cells Transl Med 6:1366-1372
Golpanian, Samuel; El-Khorazaty, Jill; Mendizabal, Adam et al. (2015) Effect of aging on human mesenchymal stem cell therapy in ischemic cardiomyopathy patients. J Am Coll Cardiol 65:125-32
Yoneyama, Kihei; Lima, João A C (2015) Alcohol consumption and myocardial remodeling in elderly women and men. Circ Cardiovasc Imaging 8:
Magalhães, Tiago A; Kishi, Satoru; George, Richard T et al. (2015) Combined coronary angiography and myocardial perfusion by computed tomography in the identification of flow-limiting stenosis - The CORE320 study: An integrated analysis of CT coronary angiography and myocardial perfusion. J Cardiovasc Comput Tomogr 9:438-45
Heldman, Alan W; DiFede, Darcy L; Fishman, Joel E et al. (2014) Transendocardial mesenchymal stem cells and mononuclear bone marrow cells for ischemic cardiomyopathy: the TAC-HFT randomized trial. JAMA 311:62-73
Suncion, Viky Y; Ghersin, Eduard; Fishman, Joel E et al. (2014) Does transendocardial injection of mesenchymal stem cells improve myocardial function locally or globally?: An analysis from the Percutaneous Stem Cell Injection Delivery Effects on Neomyogenesis (POSEIDON) randomized trial. Circ Res 114:1292-301
Karantalis, Vasileios; DiFede, Darcy L; Gerstenblith, Gary et al. (2014) Autologous mesenchymal stem cells produce concordant improvements in regional function, tissue perfusion, and fibrotic burden when administered to patients undergoing coronary artery bypass grafting: The Prospective Randomized Study of Mesenchymal Stem Ce Circ Res 114:1302-10
Donekal, Sirisha; Venkatesh, Bharath A; Liu, Yuan Chang et al. (2014) Interstitial fibrosis, left ventricular remodeling, and myocardial mechanical behavior in a population-based multiethnic cohort: the Multi-Ethnic Study of Atherosclerosis (MESA) study. Circ Cardiovasc Imaging 7:292-302
Malliaras, Konstantinos; Makkar, Raj R; Smith, Rachel R et al. (2014) Intracoronary cardiosphere-derived cells after myocardial infarction: evidence of therapeutic regeneration in the final 1-year results of the CADUCEUS trial (CArdiosphere-Derived aUtologous stem CElls to reverse ventricUlar dySfunction). J Am Coll Cardiol 63:110-22
Williams, Adam R; Hatzistergos, Konstantinos E; Addicott, Benjamin et al. (2013) Enhanced effect of combining human cardiac stem cells and bone marrow mesenchymal stem cells to reduce infarct size and to restore cardiac function after myocardial infarction. Circulation 127:213-23

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