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 five 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.[1]

Components of the Network

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 suffering from such diseases and disorders.

The Coordinating Center for Clinical Trials

Since 1971, the Coordinating Center for Clinical Trials () 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 16 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 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:

Ongoing work

In July 2008, the CCTRN opened enrollment in two studies in patients who had recently suffered heart attacks: TIME[2] () and LateTIME[3] (). 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] (). 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 (). This study is currently enrolling. The purpose of this study is 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. This study will enroll 80 patients over a one year period.

In October 2015, CCTRN opened enrollment in a study in heart failure: CONCERT (NCT02501811). This study is currently enrolling. The purpose of the study is to determine whether giving autologous Mesenchymal Stem Cells (MSCs) and/or C-kit+ Cardiac Stem Cells (CSCs) to patients with heart muscle damage is safe. It will also 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.

In the first quarter of 2016, CCTRN is planning to open enrollment in a study in anthracycline-induced cardiomyopathy (AIC): SENECA (NCT02509156). This study is NOT yet enrolling. The purpose of the study is to determine whether giving allogeneic mesenchymal stem cells (MSCs) to patients with AIC is safe and whether these treatments improve heart function.

References

  1. ↑ Simari R.D., Moyé L.A., Skarlatos S.I,, Ellis S.G., Zhao D.X., Willerson J.T., Henry T.D., Pepine C.J. Development of a network to test strategies in cardiovascular cell delivery: the NHLBI-sponsored Cardiovascular Cell Therapy Research Network (CCTRN). J. Cardiovasc. Transl. Res. 2010 Feb;3(1):30-6.
  2. ↑ Traverse J.H., Henry T.D., Vaughan D., Ellis S.G., Pepine C.J., Willerson J.T., Zhao D.X.M., Piller L.B., Penn M.S., Byrne B.J., Perin E.C., Gee A.P., Hatzopoulous A.K., McKenna D.H., Forder J.R., Taylor D.A., Cogle C.R., Olson R.E., Jorgenson B.C., Sayre S.L., Vojvodic R.W., Gordon D.J., Skarlatos S.I., Moyé L.A., Simari R.D. for the Cardiovascular Cell Therapy Research Network. 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 Following Acute Myocardial Infarction. Journal American Heart Association. 2009 Sep;158(3):356-63.
  3. ↑ Traverse J.H., Henry T.D., Vaughan D.E., Ellis S.G., Pepine C.J., Willerson J.T., Zhao D.X.M., Simpson L., Penn M.S., Byrne B.J., Perin E.C., Gee A.P., Hatzopoulous A.K., McKenna D.H., Forder J.R., Taylor D.A., Cogle C.R., Baraniuk S., Olson R.E., Jorgenson B.E., Sayre, S.L., Vojvodic, R.W., Gordon, D.J., Skarlatos, S.I., Moye, L.A., Simari, R.D. for the Cardiovascular Cell Therapy Research Network (CCTRN). Rationale and Design for Late TIME: A Phase-II, Randomized, Placebo-Controlled, Double-Blind Pilot Trial Evaluating the Safety and Effect of Administration of Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction. Texas Heart Institute Journal 2010 Aug;37(4):412-420.
  4. ↑ Traverse J.H., Henry T.D., Ellis S.G., Pepine C.J., Willerson J.T., Zhao D.X.M., Forder J.R., Byrne B.J., Hatzopoulos A.K., Penn M.S., Perin E.C., Baran K.W., Chambers J.W., Lambert C.E., Raveendran G., Simon D.I., Vaughan D.E., Simpson L.M., Gee A.P., Taylor D.A., Cogle C.R., Thomas J.D., Silva G.V., Jorgenson B.C., Olson R.E., Bowman S.D., Francescon J.L., Geither C.L., Handberg E.M., Smith D., Baraniuk S., Piller L.B., Loghin C., Aguilar D., Richman S.J., Zierold-Fairman C., Bettencourt J., Sayre S.L., Vojvodic R.W., Skarlatos S.I., Gordon D.J., Ebert R.F., Kwak M., Moyé L.A., Simari R.D. for the Cardiovascular Cell Therapy Research Network (CCTRN). Effect of Intracoronary Delivery of Autologous Bone Marrow Mononuclear Cells Two to Three Weeks Following Acute Myocardial Infarction on Left-Ventricular Function: The LateTIME Randomized Trial. JAMA. 2011 Nov; 306(19):2110-2119.
  5. ↑ Traverse J.H., Henry T.D., Pepine C.J., Willerson J.T., Zhao D.X.M., Ellis S.G., Forder J.R., Anderson R.D., Hatzopoulos A.K., Penn M.S., Perin E.C., Chambers J.W., Baran K.W., Raveendran G., Lambert C.E., Lerman, A, Simon D.I., Vaughan D.E., Lai D., Gee A.P., Taylor D.A., Cogle C.R., Thomas J.D., Silva G.V., Olson R.E., Bowman S.D., Francescon J.L., Geither C.L., Handberg E.M., Kappenman C., Westbrook L., Piller L.B., Simpson, L.M., Baraniuk S., Loghin C., Aguilar D., Richman S.J., Zierold-Fairman C., Spoon, D.B., Bettencourt J., Sayre S.L., Vojvodic R.W., Skarlatos S.I., Gordon D.J., Ebert R.F., Kwak M., Moyé L.A., Simari R.D. for the Cardiovascular Cell Therapy Research Network (CCTRN). Effect of Use and Timing of Bone Marrow Mononuclear Cell Delivery on Left Ventricular Function After Acute Myocardial Infarction: The TIME Randomized Trial. JAMA. 2012 Dec; 308(22):2380-9.
  6. ↑ Willerson J.T., Perin E.C., Ellis S.G., Pepine C.J., Henry T.D., Zhao D.X.M., Lai D., Penn M.S., Byrne B.J., Silva G., Gee A., Traverse J.H., Hatzopoulos A.K., Forder J.R., Martin D., Kronenberg M., Taylor D.A., Cogle C.R., Baraniuk S., Westbrook L., Sayre S.L., Vojvodic R.W., Gordon D.J., Skarlatos S.I., Moyé L.A., Simari R.D., for the Cardiovascular Cell Therapy Research Network (CCTRN) Rationale and Design for the Intramyocardial Injection of Autologous Bone Marrow Mononuclear Cells for Patients with Chronic Ischemic Heart Disease and Left Ventricular Dysfunction Trial (FOCUS). American Heart Journal. 2010 Aug; 160(2):215-223.
  7. ↑ Perin E.C., Willerson J.T., Pepine C.J., Henry T.D., Ellis S.G., Zhao D.X.M., Silva G.V., Lai D., Thomas J.D., Kronenberg M.W., Martin A.D., Anderson R.D., Traverse J.H., Penn M.S., Anwaruddin S., Hatzopoulos A.K., Gee A.P., Taylor D.A., Cogle C.R., Smith D., Westbrook L., Handberg E.M., Olson R.E., Geither C.L., Bowman S.D., Francescon J.L., Baraniuk S., Piller L.B., Simpson, L.M., Loghin C., Aguilar D., Richman S.J., Zierold-Fairman C., Spoon, D.B., Bettencourt J., Sayre S.L., Vojvodic R.W., Skarlatos S.I., Gordon D.J., Ebert R.F., Kwak M., Moyé L.A., Simari R.D. for the Cardiovascular Cell Therapy Research Network (CCTRN). Effect of Transendocardial Delivery of Autologous Bone Marrow Mononuclear Cells on Functional Capacity, Left Ventricular Function, and Perfusion in Chronic Ischemic Heart Failure: The FOCUS-CCTRN Trial. JAMA. 2012 April; 307(16):1717-26.

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