View source for Cardiovascular Cell Therapy Research Network

{{more footnotes needed|date=May 2011}}
'''Cardiovascular Cell Therapy Research Network''' ('''CCTRN''') is a network of [[physician]]s, [[scientist]]s, and support staff dedicated to studying [[stem cell therapy]] for treating [[heart disease]]. The CCTRN is funded by the [[National Institutes of Health]] (NIH) and includes expert researchers with experience in cardiovascular care at seven stem cell centers in the [[United States]].  The goals of the Network are to complete research studies that will potentially lead to more effective treatments for patients with [[cardiovascular disease]], and to share knowledge quickly with the [[healthcare]] community.

==Mission statement==
The mission of the CCTRN is to achieve [[public health]] advances for the treatment of cardiovascular diseases, through the conduct and dissemination of collaborative research leading to [[evidence-based treatment]] options and improved outcome for patients with heart disease.<ref>{{cite journal |vauthors=Simari RD, Moyé LA, Skarlatos SI, Ellis SG, Zhao DX, Willerson JT, Henry TD, Pepine CJ |title=Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN) |journal=J Cardiovasc Transl Res |volume=3 |issue=1 |pages=30–6 |date=February 2010 |pmid=20445812 |pmc=2863075 |doi=10.1007/s12265-009-9160-3 }}</ref>

==Components of the Network==
'''The sponsor'''

The [[National Heart, Lung, and Blood Institute]] ([http://www.nhlbi.nih.gov/ NHLBI]) is one of 27 institutes/centers of the National Institutes of Health (NIH) and supports research related to the causes, prevention, diagnosis, and treatment of [[heart]], [[blood vessel]], [[lung]], and [[blood disease]]s; and [[sleep disorder]]s. The NHLBI plans and directs research in the development and evaluation of interventions and devices related to prevention, treatment, and rehabilitation of patients with such diseases and disorders.

'''The Coordinating Center for Clinical Trials'''

Since 1971, the [[Coordinating Center for Clinical Trials]] ([https://sph.uth.edu/research/centers/ccct/]) at The [[University of Texas School of Public Health]] has played a leading role in cardiovascular disease and vision research by serving as a coordinating center for 25 nationwide multicenter [[clinical trial]]s. The CCCT's primary function is to provide and coordinate all operations, procedures, and activities of a large-scale randomized controlled clinical trial. The CCCT serves as the Data Coordinating Center for the CCTRN. The DCC was led by Lemuel Moye (2006-2019) and [[Barry R. Davis]] (2019-2021).

'''The clinical sites'''

The CCTRN includes seven stem cell centers in the United States with experience and expertise in clinical trials studying treatments for heart disease and peripheral artery disease. These sites include:

* [[Minneapolis Heart Institute Foundation]] ([http://www.mplsheart.org/])
* [[Texas Heart Institute|Texas Heart Institute Stem Cell Center]]([http://www.texasheart.org/Research/StemCellCenter/index.cfm])
* [[University of Florida College of Medicine]] ([https://web.archive.org/web/20110721174859/http://cctrn.medicine.ufl.edu/])
* [[University of Louisville]] ([http://louisville.edu/medschool/cardiology/])
* [[Vascular and Cardiac Center for Adult Stem Cell Therapy (VC-CAST)]] 
* [[Miller School of Medicine|University of Miami Miller School of Medicine]] ([http://isci.med.miami.edu/])
* [[Stanford University]] ([http://cvmedicine.stanford.edu/vascularmedicine/])

==Body of work==
In July 2008, the CCTRN opened enrollment in two studies in patients who had recently had  [[heart attack]]s: TIME<ref>{{cite journal |vauthors=Traverse JH, Henry TD, Vaughan DE, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Piller LB, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moye' LA, Simari RD |title=Rationale and design for TIME: A phase II, randomized, double-blind, placebo-controlled pilot trial evaluating the safety and effect of timing of administration of bone marrow mononuclear cells after acute myocardial infarction |journal=Am Heart J |volume=158 |issue=3 |pages=356–63 |date=September 2009 |pmid=19699857 |pmc=2784639 |doi=10.1016/j.ahj.2009.06.009 }}</ref> ([http://www.clinicaltrials.gov/ct2/show/NCT00684021?term=Acute+Myocardial+Infarction+and+Bone+Marrow&rank=19 (NCT00684021)]) and LateTIME<ref>{{cite journal |vauthors=Traverse JH, Henry TD, Vaughan DE, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Simpson LM, Penn MS, Byrne BJ, Perin EC, Gee AP, Hatzopoulos AK, McKenna DH, Forder JR, Taylor DA, Cogle CR, Baraniuk S, Olson RE, Jorgenson BC, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moyè LA, Simari RD |title=LateTIME: a phase-II, randomized, double-blinded, placebo-controlled, pilot trial evaluating the safety and effect of administration of bone marrow mononuclear cells 2 to 3 weeks after acute myocardial infarction |journal=Tex Heart Inst J |volume=37 |issue=4 |pages=412–420 |date=2010 |pmid=20844613 |pmc=2929864 }}</ref> ([http://www.clinicaltrials.gov/ct2/show/NCT00684060?term=Acute+Myocardial+Infarction+and+Bone+Marrow&rank=20 (NCT00684060)]).  The purpose of these studies was to determine if [[stem cell]]s safely taken from an individual's [[bone marrow]] could be [[Organ transplantation|transplant]]ed back into the injured heart muscle of the individual and improve the heart's ability to pump following a heart attack, as well as to determine the best time for transplanting the cells following a heart attack.  The results of both studies were presented at the American Heart Association (AHA) Scientific meetings in 2011 (LateTIME) and 2012 (TIME), and simultaneously published in JAMA.<ref>{{cite journal |vauthors=Traverse JH, Henry TD, Ellis SG, Pepine CJ, Willerson JT, Zhao DX, Forder JR, Byrne BJ, Hatzopoulos AK, Penn MS, Perin EC, Baran KW, Chambers J, Lambert C, Raveendran G, Simon DI, Vaughan DE, Simpson LM, Gee AP, Taylor DA, Cogle CR, Thomas JD, Silva GV, Jorgenson BC, Olson RE, Bowman S, Francescon J, Geither C, Handberg E, Smith DX, Baraniuk S, Piller LB, Loghin C, Aguilar D, Richman S, Zierold C, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moyé LA, Simari RD |title=Effect of intracoronary delivery of autologous bone marrow mononuclear cells 2 to 3 weeks following acute myocardial infarction on left ventricular function: the LateTIME randomized trial |journal=JAMA |volume=306 |issue=19 |pages=2110–9 |date=November 2011 |pmid=22084195 |pmc=3600981 |doi=10.1001/jama.2011.1670 }}</ref><ref>{{cite journal |vauthors=Traverse JH, Henry TD, Pepine CJ, Willerson JT, Zhao DX, Ellis SG, Forder JR, Anderson RD, Hatzopoulos AK, Penn MS, Perin EC, Chambers J, Baran KW, Raveendran G, Lambert C, Lerman A, Simon DI, Vaughan DE, Lai D, Gee AP, Taylor DA, Cogle CR, Thomas JD, Olson RE, Bowman S, Francescon J, Geither C, Handberg E, Kappenman C, Westbrook L, Piller LB, Simpson LM, Baraniuk S, Loghin C, Aguilar D, Richman S, Zierold C, Spoon DB, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moyé LA, Simari RD |title=Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial |journal=JAMA |volume=308 |issue=22 |pages=2380–9 |date=December 2012 |pmid=23129008 |pmc=3652242 |doi=10.1001/jama.2012.28726 }}</ref>

In March 2009, the CCTRN opened enrollment in a [[heart failure]] study: FOCUS <ref>{{cite journal |vauthors=Willerson JT, Perin EC, Ellis SG, Pepine CJ, Henry TD, Zhao DX, Lai D, Penn MS, Byrne BJ, Silva G, Gee A, Traverse JH, Hatzopoulos AK, Forder JR, Martin D, Kronenberg M, Taylor DA, Cogle CR, Baraniuk S, Westbrook L, Sayre SL, Vojvodic RW, Gordon DJ, Skarlatos SI, Moyé LA, Simari RD |title=Intramyocardial injection of autologous bone marrow mononuclear cells for patients with chronic ischemic heart disease and left ventricular dysfunction (First Mononuclear Cells injected in the US [FOCUS]): Rationale and design |journal=Am Heart J |volume=160 |issue=2 |pages=215–23 |date=August 2010 |pmid=20691824 |pmc=2921924 |doi=10.1016/j.ahj.2010.03.029 }}</ref> ([http://www.clinicaltrials.gov/ct2/show/NCT00824005?term=Heart+Failure+and+Bone+Marrow&rank=19 (NCT00824005)]).  The purpose of this study was to determine the safety and effectiveness of injecting bone marrow stem cells into heart muscle in an attempt to promote blood vessel growth that could potentially improve the [[blood supply]] in [https://health.google.com/health/ref/Heart+failure hearts that are failing].  This study recruited patients who had heart failure, but would no longer benefit from other forms of standard treatment such as surgery or [[coronary artery]] repair procedures such as [[balloon angioplasty]] or [[stent]] placement.  The results of this study were presented at the American College of Cardiology (ACC) Annual Meeting in 2012 and simultaneously published in JAMA.<ref>{{cite journal |vauthors=Perin EC, Willerson JT, Pepine CJ, Henry TD, Ellis SG, Zhao DX, Silva GV, Lai D, Thomas JD, Kronenberg MW, Martin AD, Anderson RD, Traverse JH, Penn MS, Anwaruddin S, Hatzopoulos AK, Gee AP, Taylor DA, Cogle CR, Smith D, Westbrook L, Chen J, Handberg E, Olson RE, Geither C, Bowman S, Francescon J, Baraniuk S, Piller LB, Simpson LM, Loghin C, Aguilar D, Richman S, Zierold C, Bettencourt J, Sayre SL, Vojvodic RW, Skarlatos SI, Gordon DJ, Ebert RF, Kwak M, Moyé LA, Simari RD |title=Effect of transendocardial delivery of autologous bone marrow mononuclear cells on functional capacity, left ventricular function, and perfusion in chronic heart failure: the FOCUS-CCTRN trial |journal=JAMA |volume=307 |issue=16 |pages=1717–26 |date=April 2012 |pmid=22447880 |pmc=3600947 |doi=10.1001/jama.2012.418 }}</ref>

In June 2013, CCTRN opened enrollment in a study in [[peripheral artery disease]]: PACE <ref>{{cite journal |vauthors=Perin EC, Murphy M, Cooke JP, Moyé L, Henry TD, Bettencourt J, Gahremanpour A, Leeper N, Anderson RD, Hiatt WR, Lima JA, Venkatesh B, Sayre SL, Vojvodic RW, Taylor DA, Ebert RF, Hirsch AT |title=Rationale and design for PACE: patients with intermittent claudication injected with ALDH bright cells |journal=Am Heart J |volume=168 |issue=5 |pages=667–73 |date=November 2014 |pmid=25440794 |pmc=4254580 |doi=10.1016/j.ahj.2014.07.021 }}</ref> ([http://www.clinicaltrials.gov/ct2/show/NCT01774097?term=PACE+PAD&rank=2 (NCT01774097)]).  The purpose of this study was to determine the safety and effectiveness of bone marrow-derived stem cell therapy on improving blood flow and walking ability in patients with peripheral artery disease.  The results of this study were published in Circulation in 2017.<ref>{{Cite journal |last=Perin |first=Emerson C. |last2=Murphy |first2=Michael P. |last3=March |first3=Keith L. |last4=Bolli |first4=Roberto |last5=Loughran |first5=John |last6=Yang |first6=Phillip C. |last7=Leeper |first7=Nicholas J. |last8=Dalman |first8=Ronald L. |last9=Alexander |first9=Jason |last10=Henry |first10=Timothy D. |last11=Traverse |first11=Jay H. |last12=Pepine |first12=Carl J. |last13=Anderson |first13=R. David |last14=Berceli |first14=Scott |last15=Willerson |first15=James T. |date=2017-04-11 |title=Evaluation of Cell Therapy on Exercise Performance and Limb Perfusion in Peripheral Artery Disease: The CCTRN PACE Trial (Patients With Intermittent Claudication Injected With ALDH Bright Cells) |url=https://www.ahajournals.org/doi/10.1161/CIRCULATIONAHA.116.025707 |journal=Circulation |volume=135 |issue=15 |pages=1417–28 |doi=10.1161/CIRCULATIONAHA.116.025707 |pmid=28209728 |pmc=5388585 }}</ref>

In October 2015, CCTRN opened enrollment in a study in [[heart failure]]: CONCERT-HF <ref>{{Cite journal |last=Bolli |first=Roberto |last2=Hare |first2=Joshua M. |last3=March |first3=Keith L. |last4=Pepine |first4=Carl J. |last5=Willerson |first5=James T. |last6=Perin |first6=Emerson C. |last7=Yang |first7=Phillip C. |last8=Henry |first8=Timothy D. |last9=Traverse |first9=Jay H. |last10=Mitrani |first10=Raul D. |last11=Khan |first11=Aisha |last12=Hernandez-Schulman |first12=Ivonne |last13=Taylor |first13=Doris A. |last14=DiFede |first14=Darcy L. |last15=Lima |first15=João A.C. |date=2018-06-08 |title=Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit + Cardiac Stem Cells As Regenerative Therapy for Heart Failure) |url=https://www.ahajournals.org/doi/10.1161/CIRCRESAHA.118.312978 |journal=Circulation Research |volume=122 |issue=12 |pages=1703–15 |doi=10.1161/CIRCRESAHA.118.312978 |pmid=29703749 |pmc=5993622 }}</ref> [https://clinicaltrials.gov/ct2/show/NCT02501811?term=CONCERT&rank=6 (NCT02501811)]. The purpose of the study was to determine whether giving autologous Mesenchymal Stem Cells (MSCs) and/or C-kit+ cells to patients with heart muscle damage is safe and to help us learn whether these treatments improve heart function for people who are not ideal candidates for other forms of standard therapy such as surgery.  The results of this study were published in the European Journal of Heart Failure in 2021.<ref>{{Cite journal |last=Bolli |first=Roberto |last2=Mitrani |first2=Raul D. |last3=Hare |first3=Joshua M. |last4=Pepine |first4=Carl J. |last5=Perin |first5=Emerson C. |last6=Willerson |first6=James T. |last7=Traverse |first7=Jay H. |last8=Henry |first8=Timothy D. |last9=Yang |first9=Phillip C. |last10=Murphy |first10=Michael P. |last11=March |first11=Keith L. |last12=Schulman |first12=Ivonne H. |last13=Ikram |first13=Sohail |last14=Lee |first14=David P. |last15=O'Brien |first15=Connor |date=April 2021 |title=A Phase II study of autologous mesenchymal stromal cells and c‐kit positive cardiac cells, alone or in combination, in patients with ischaemic heart failure: the CCTRN CONCERT‐HF trial |url=https://onlinelibrary.wiley.com/doi/10.1002/ejhf.2178 |journal=European Journal of Heart Failure |volume=23 |issue=4 |pages=661–674 |doi=10.1002/ejhf.2178 |hdl=1805/31344 |hdl-access=free  |pmid=33811444 |pmc=8357352 }}</ref>

In September 2016, CCTRN opened enrollment in a study in [[anthracycline-induced cardiomyopathy]] (AIC): SENECA <ref>{{Cite journal |last=Bolli |first=Roberto |last2=Hare |first2=Joshua M. |last3=Henry |first3=Timothy D. |last4=Lenneman |first4=Carrie G. |last5=March |first5=Keith L. |last6=Miller |first6=Kathy |last7=Pepine |first7=Carl J. |last8=Perin |first8=Emerson C. |last9=Traverse |first9=Jay H. |last10=Willerson |first10=James T. |last11=Yang |first11=Phillip C. |last12=Gee |first12=Adrian P. |last13=Lima |first13=João A. |last14=Moyé |first14=Lem |last15=Vojvodic |first15=Rachel W. |date=July 2018 |title=Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial |url=https://linkinghub.elsevier.com/retrieve/pii/S0002870318300528 |journal=American Heart Journal |volume=201 |pages=54–62 |doi=10.1016/j.ahj.2018.02.009 |pmc=7282462 |pmid=29910056}}</ref> [https://clinicaltrials.gov/ct2/show/NCT02509156?term=SENECA&rank=4 (NCT02509156)]. The purpose of the study was to determine whether giving allogeneic mesenchymal stem cells (MSCs) to patients with AIC is safe and whether these treatments improve heart function. The results of this study were published in JACC CardioOncology in 2020.<ref>{{Cite journal |last=Bolli |first=Roberto |last2=Perin |first2=Emerson C. |last3=Willerson |first3=James T. |last4=Yang |first4=Phillip C. |last5=Traverse |first5=Jay H. |last6=Henry |first6=Timothy D. |last7=Pepine |first7=Carl J. |last8=Mitrani |first8=Raul D. |last9=Hare |first9=Joshua M. |last10=Murphy |first10=Michael P. |last11=March |first11=Keith L. |last12=Ikram |first12=Sohail |last13=Lee |first13=David P. |last14=O’Brien |first14=Connor |last15=Durand |first15=Jean-Bernard |date=November 2020 |title=Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients: The CCTRN SENECA Trial |url=https://linkinghub.elsevier.com/retrieve/pii/S2666087320302143 |journal=JACC: CardioOncology |volume=2 |issue=4 |pages=581–595 |doi=10.1016/j.jaccao.2020.09.001|hdl=1805/28750 |hdl-access=free |pmid=33403362 |pmc=7781291 }}</ref>

==References==
{{Reflist}}

==External links==
* [https://sph.uth.edu/research/centers/ccct/cctrn/ CCTRN at UTHealth — School of Public Health]
* [http://www.clinicaltrials.gov/ ClinicalTrials.gov]
* [http://www.isscr.org/ International Society for Stem Cell Research]
* [https://web.archive.org/web/20100613051001/http://www.hhs.gov/ohrp/outreach/documents/3panelfinal.pdf Becoming a Research Volunteer (OHRP)]

{{DEFAULTSORT:Cardiovascular Cell Therapy Research Network (Cctrn)}}
[[Category:Heart disease organizations]]
[[Category:Stem cell research]]