Wikipedia

Cardiovascular Cell Therapy Research Network

Cardiovascular Cell Therapy Research Network (CCTRN) is a network of physicians, scientists, 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

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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.[1]

Components of the Network

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The sponsor

The National Heart, Lung, and Blood Institute (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 diseases; and sleep disorders. 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 ([1]) 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 trials. 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:

Body of work

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In July 2008, the CCTRN opened enrollment in two studies in patients who had recently had heart attacks: TIME[2] ((NCT00684021)) and LateTIME[3] ((NCT00684060)). The purpose of these studies was to determine if stem cells safely taken from an individual's bone marrow could be transplanted 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.[4][5]

In March 2009, the CCTRN opened enrollment in a heart failure study: FOCUS [6] ((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 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.[7]

In June 2013, CCTRN opened enrollment in a study in peripheral artery disease: PACE [8] ((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.[9]

In October 2015, CCTRN opened enrollment in a study in heart failure: CONCERT-HF [10] (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.[11]

In September 2016, CCTRN opened enrollment in a study in anthracycline-induced cardiomyopathy (AIC): SENECA [12] (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.[13]

References

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  1. ^ Simari RD, Moyé LA, Skarlatos SI, Ellis SG, Zhao DX, Willerson JT, Henry TD, Pepine CJ (February 2010). "Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN)". J Cardiovasc Transl Res. 3 (1): 30–6. doi:10.1007/s12265-009-9160-3. PMC 2863075. PMID 20445812.
  2. ^ 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 (September 2009). "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". Am Heart J. 158 (3): 356–63. doi:10.1016/j.ahj.2009.06.009. PMC 2784639. PMID 19699857.
  3. ^ 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 (2010). "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". Tex Heart Inst J. 37 (4): 412–420. PMC 2929864. PMID 20844613.
  4. ^ 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 (November 2011). "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". JAMA. 306 (19): 2110–9. doi:10.1001/jama.2011.1670. PMC 3600981. PMID 22084195.
  5. ^ 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 (December 2012). "Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial". JAMA. 308 (22): 2380–9. doi:10.1001/jama.2012.28726. PMC 3652242. PMID 23129008.
  6. ^ 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 (August 2010). "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". Am Heart J. 160 (2): 215–23. doi:10.1016/j.ahj.2010.03.029. PMC 2921924. PMID 20691824.
  7. ^ 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 (April 2012). "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". JAMA. 307 (16): 1717–26. doi:10.1001/jama.2012.418. PMC 3600947. PMID 22447880.
  8. ^ 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 (November 2014). "Rationale and design for PACE: patients with intermittent claudication injected with ALDH bright cells". Am Heart J. 168 (5): 667–73. doi:10.1016/j.ahj.2014.07.021. PMC 4254580. PMID 25440794.
  9. ^ Perin, Emerson C.; Murphy, Michael P.; March, Keith L.; Bolli, Roberto; Loughran, John; Yang, Phillip C.; Leeper, Nicholas J.; Dalman, Ronald L.; Alexander, Jason; Henry, Timothy D.; Traverse, Jay H.; Pepine, Carl J.; Anderson, R. David; Berceli, Scott; Willerson, James T. (2017-04-11). "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)". Circulation. 135 (15): 1417–28. doi:10.1161/CIRCULATIONAHA.116.025707. PMC 5388585. PMID 28209728.
  10. ^ Bolli, Roberto; Hare, Joshua M.; March, Keith L.; Pepine, Carl J.; Willerson, James T.; Perin, Emerson C.; Yang, Phillip C.; Henry, Timothy D.; Traverse, Jay H.; Mitrani, Raul D.; Khan, Aisha; Hernandez-Schulman, Ivonne; Taylor, Doris A.; DiFede, Darcy L.; Lima, João A.C. (2018-06-08). "Rationale and Design of the CONCERT-HF Trial (Combination of Mesenchymal and c-kit + Cardiac Stem Cells As Regenerative Therapy for Heart Failure)". Circulation Research. 122 (12): 1703–15. doi:10.1161/CIRCRESAHA.118.312978. PMC 5993622. PMID 29703749.
  11. ^ Bolli, Roberto; Mitrani, Raul D.; Hare, Joshua M.; Pepine, Carl J.; Perin, Emerson C.; Willerson, James T.; Traverse, Jay H.; Henry, Timothy D.; Yang, Phillip C.; Murphy, Michael P.; March, Keith L.; Schulman, Ivonne H.; Ikram, Sohail; Lee, David P.; O'Brien, Connor (April 2021). "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". European Journal of Heart Failure. 23 (4): 661–674. doi:10.1002/ejhf.2178. hdl:1805/31344. PMC 8357352. PMID 33811444.
  12. ^ Bolli, Roberto; Hare, Joshua M.; Henry, Timothy D.; Lenneman, Carrie G.; March, Keith L.; Miller, Kathy; Pepine, Carl J.; Perin, Emerson C.; Traverse, Jay H.; Willerson, James T.; Yang, Phillip C.; Gee, Adrian P.; Lima, João A.; Moyé, Lem; Vojvodic, Rachel W. (July 2018). "Rationale and Design of the SENECA (StEm cell iNjECtion in cAncer survivors) Trial". American Heart Journal. 201: 54–62. doi:10.1016/j.ahj.2018.02.009. PMC 7282462. PMID 29910056.
  13. ^ Bolli, Roberto; Perin, Emerson C.; Willerson, James T.; Yang, Phillip C.; Traverse, Jay H.; Henry, Timothy D.; Pepine, Carl J.; Mitrani, Raul D.; Hare, Joshua M.; Murphy, Michael P.; March, Keith L.; Ikram, Sohail; Lee, David P.; O’Brien, Connor; Durand, Jean-Bernard (November 2020). "Allogeneic Mesenchymal Cell Therapy in Anthracycline-Induced Cardiomyopathy Heart Failure Patients: The CCTRN SENECA Trial". JACC: CardioOncology. 2 (4): 581–595. doi:10.1016/j.jaccao.2020.09.001. hdl:1805/28750. PMC 7781291. PMID 33403362.
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