The Minnesota Regional Cardiovascular Cell Therapy Clinical Research Network (MNCCTRN) is ideally suited to continue its key role in the evaluation of novel cell therapy strategies for individuals with cardiovascular disease. MNCCTRN is a consortium of five cutting-edge Minnesota cardiovascular institutions (Minneapolis Heart Institute at Abbott Northwestern Hospital, University of Minnesota, Mayo Clinic, Mercy Hospital and United Hospital), in conjunction with the Minnesota Molecular and Cellular Therapeutics (NHLBI-sponsored Production Assistance for Cellular Therapies (PACT) group) and the Center for Cardiovascular Repair Biorepository at the University of Minnesota. We propose to add 2 experienced institutions, Hennepin County Medical Center and the Minneapolis VA Medical Center. The MNCCTRN has demonstrated it is a critically important partner to the mission of the NIH, and the institutions in this application, all of which aim to improve patients'health and save lives, s it provides a unique opportunity to translate promising cell therapy basic science into novel and successful clinical alternative for patients with limited options. MNCCTRN have nationally recognized expertise with large clinical patient populations demonstrating unmet need and a high likelihood of benefit from cellular therapy (e.g., acute myocardial infarction, refractory angina, and end-stage heart failure, including patients with left ventricular assist devices and peripheral artery disease). We have an outstanding track record of high enrollment with high quality data in multicenter trials in these areas, including those sponsored by the initial CCTRN grant (HL-06-001). Our extensive experience includes expertise In trial design, delivery techniques, patient enrollment, and endpoint measurements including state-of-the-art imaging, an invaluable biorepository and the distinct advantage of being one of five PACT institutions for manufacture and distribution of cell therapy products. In addition, we propose two clinical research skills development programs: the 1st a unique proposal for clinical research coordinator training and a 2nd for clinical research investigators. The MNCCTRN's goal is to generate further scientific knowledge and address clinically relevant questions on mechanisms of cell therapies and effects on cardiovascular disease. We are ideally suited to continue our critical contribution to the NHLBI cardiovascular cell therapy research network, capitalizing on our basic research skills and unsurpassed ability to conduct well executed clinical trials.

Public Health Relevance

Despite all the therapeutic advances made to date, cardiovascular disease remains to be a major public health concern in the United States. Further understanding and translation of cell therapy into effective therapeutic modalities for cardiovascular disease may provide significant improvements to patients without options through the world. The MNCCTRN, with its clinical trial and cardiovascular cell therapy experience and infrastructure, will continue to make key contributions from basic science to multicenter clinical trials.

Agency
National Institute of Health (NIH)
Institute
National Heart, Lung, and Blood Institute (NHLBI)
Type
Research Project with Complex Structure Cooperative Agreement (UM1)
Project #
7UM1HL087394-08
Application #
8628864
Study Section
Special Emphasis Panel (ZHL1-CSR-O (F2))
Program Officer
Ebert, Ray F
Project Start
2007-01-01
Project End
2019-02-28
Budget Start
2014-03-01
Budget End
2015-02-28
Support Year
8
Fiscal Year
2014
Total Cost
$799,845
Indirect Cost
$49,777
Name
Allina Health System
Department
Type
DUNS #
807948708
City
Minneapolis
State
MN
Country
United States
Zip Code
55440
Schutt, Robert C; Trachtenberg, Barry H; Cooke, John P et al. (2015) Bone marrow characteristics associated with changes in infarct size after STEMI: a biorepository evaluation from the CCTRN TIME trial. Circ Res 116:99-107
Simari, Robert D; Pepine, Carl J; Traverse, Jay H et al. (2014) Bone marrow mononuclear cell therapy for acute myocardial infarction: a perspective from the cardiovascular cell therapy research network. Circ Res 114:1564-8
Ascheim, Deborah D; Gelijns, Annetine C; Goldstein, Daniel et al. (2014) Mesenchymal precursor cells as adjunctive therapy in recipients of contemporary left ventricular assist devices. Circulation 129:2287-96
Traverse, Jay H; Henry, Timothy D; Pepine, Carl J et al. (2014) One-year follow-up of intracoronary stem cell delivery on left ventricular function following ST-elevation myocardial infarction. JAMA 311:301-2
Delewi, Ronak; Hirsch, Alexander; Tijssen, Jan G et al. (2014) Impact of intracoronary bone marrow cell therapy on left ventricular function in the setting of ST-segment elevation myocardial infarction: a collaborative meta-analysis. Eur Heart J 35:989-98
Cogle, Christopher R; Wise, Elizabeth; Meacham, Amy M et al. (2014) Detailed analysis of bone marrow from patients with ischemic heart disease and left ventricular dysfunction: BM CD34, CD11b, and clonogenic capacity as biomarkers for clinical outcomes. Circ Res 115:867-74
Perin, Emerson C; Murphy, Michael; Cooke, John P et al. (2014) Rationale and design for PACE: patients with intermittent claudication injected with ALDH bright cells. Am Heart J 168:667-73