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  1. Article ; Online: Cell therapy and satellite centers: the Cardiovascular Cell Therapy Research Network experience.

    Moyé, Lemuel A / Henry, Timothy D / Baran, Kenneth W / Bettencourt, Judy / Bruhn-Ding, Barb / Caldwell, Emily / Chambers, Jeffrey / Flood, Kelly / Francescon, Judy / Bowman, Sherry / Kappenman, Casey / Kar, Biswajit / Lambert, Charles / LaRock, Jody / Lerman, Amir / Mazzurco, Stacey / Prashad, Rakesh / Raveendran, Ganesh / Simon, Daniel /
    Westbrook, Lynette / Simari, Robert D

    Contemporary clinical trials

    2011  Volume 32, Issue 6, Page(s) 841–847

    Abstract: Due to the changing population in patients with myocardial infarction, recruiting patients in clinical trials continues to challenge clinical investigators. The Cardiovascular Cell Therapy Research Network (CCTRN) chose to expand the reach and power of ... ...

    Abstract Due to the changing population in patients with myocardial infarction, recruiting patients in clinical trials continues to challenge clinical investigators. The Cardiovascular Cell Therapy Research Network (CCTRN) chose to expand the reach and power of its recruitment effort by incorporating both referral and treatment satellite centers. Eight treatment satellites were successfully identified and they screened patients over a two year period. The result of this effort was an increase in recruitment, with these treatment satellites contributing 30% of the patients to two of the three Network studies. The hurdles that these satellite treatment centers faced and how they surmounted them provide instruction to clinical research groups eager to expand to satellite systems and to health care practitioners who are interested in taking part in multicenter clinical trials.
    MeSH term(s) Biomedical Research/methods ; Cardiovascular Diseases/therapy ; Cell- and Tissue-Based Therapy/methods ; Community Health Centers ; Humans ; Treatment Outcome
    Language English
    Publishing date 2011-07-08
    Publishing country United States
    Document type Journal Article ; Review
    ZDB-ID 2182176-8
    ISSN 1559-2030 ; 1551-7144
    ISSN (online) 1559-2030
    ISSN 1551-7144
    DOI 10.1016/j.cct.2011.07.001
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  2. Article ; Online: Effect of the use and timing of bone marrow mononuclear cell delivery on left ventricular function after acute myocardial infarction: the TIME randomized trial.

    Traverse, Jay H / Henry, Timothy D / Pepine, Carl J / Willerson, James T / Zhao, David X M / Ellis, Stephen G / Forder, John R / Anderson, R David / Hatzopoulos, Antonis K / Penn, Marc S / Perin, Emerson C / Chambers, Jeffrey / Baran, Kenneth W / Raveendran, Ganesh / Lambert, Charles / Lerman, Amir / Simon, Daniel I / Vaughan, Douglas E / Lai, Dejian /
    Gee, Adrian P / Taylor, Doris A / Cogle, Christopher R / Thomas, James D / Olson, Rachel E / Bowman, Sherry / Francescon, Judy / Geither, Carrie / Handberg, Eileen / Kappenman, Casey / Westbrook, Lynette / Piller, Linda B / Simpson, Lara M / Baraniuk, Sarah / Loghin, Catalin / Aguilar, David / Richman, Sara / Zierold, Claudia / Spoon, Daniel B / Bettencourt, Judy / Sayre, Shelly L / Vojvodic, Rachel W / Skarlatos, Sonia I / Gordon, David J / Ebert, Ray F / Kwak, Minjung / Moyé, Lemuel A / Simari, Robert D

    JAMA

    2012  Volume 308, Issue 22, Page(s) 2380–2389

    Abstract: Context: While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been ... ...

    Abstract Context: While the delivery of cell therapy after ST-segment elevation myocardial infarction (STEMI) has been evaluated in previous clinical trials, the influence of the timing of cell delivery on the effect on left ventricular function has not been analyzed.
    Objectives: To determine the effect of intracoronary autologous bone marrow mononuclear cell (BMC) delivery after STEMI on recovery of global and regional left ventricular function and whether timing of BMC delivery (3 days vs 7 days after reperfusion) influences this effect.
    Design, setting, and patients: A randomized, 2 × 2 factorial, double-blind, placebo-controlled trial, Timing In Myocardial infarction Evaluation (TIME) enrolled 120 patients with left ventricular dysfunction (left ventricular ejection fraction [LVEF] ≤ 45%) after successful primary percutaneous coronary intervention (PCI) of anterior STEMI between July 17, 2008, and November 15, 2011, as part of the Cardiovascular Cell Therapy Research Network sponsored by the National Heart, Lung, and Blood Institute.
    Interventions: Intracoronary infusion of 150 × 106 BMCs or placebo (randomized 2:1) within 12 hours of aspiration and cell processing administered at day 3 or day 7 (randomized 1:1) after treatment with PCI.
    Main outcome measures: The primary end points were change in global (LVEF) and regional (wall motion) left ventricular function in infarct and border zones at 6 months measured by cardiac magnetic resonance imaging and change in left ventricular function as affected by timing of treatment on day 3 vs day 7. The secondary end points included major adverse cardiovascular events as well as changes in left ventricular volumes and infarct size.
    Results: The mean (SD) patient age was 56.9 (10.9) years and 87.5% of participants were male. At 6 months, there was no significant increase in LVEF for the BMC group (45.2% [95% CI, 42.8% to 47.6%] to 48.3% [95% CI, 45.3% to 51.3%) vs the placebo group (44.5% [95% CI, 41.0% to 48.0%] to 47.8% [95% CI, 43.4% to 52.2%]) (P = .96). There was no significant treatment effect on regional left ventricular function observed in either infarct or border zones. There were no significant differences in change in global left ventricular function for patients treated at day 3 (−0.9% [95% CI, −6.6% to 4.9%], P = .76) or day 7 (1.1% [95% CI, −4.7% to 6.9%], P = .70). The timing of treatment had no significant effect on regional left ventricular function recovery. Major adverse events were rare among all treatment groups.
    Conclusion: Among patients with STEMI treated with primary PCI, the administration of intracoronary BMCs at either 3 days or 7 days after the event had no significant effect on recovery of global or regional left ventricular function compared with placebo.
    Trial registration: clinicaltrials.gov Identifier: NCT00684021.
    MeSH term(s) Aged ; Bone Marrow Transplantation/methods ; Double-Blind Method ; Female ; Humans ; Magnetic Resonance Imaging ; Male ; Middle Aged ; Myocardial Infarction/complications ; Myocardial Infarction/therapy ; Time Factors ; Treatment Outcome ; Ventricular Dysfunction, Left/complications ; Ventricular Dysfunction, Left/therapy
    Language English
    Publishing date 2012-11-06
    Publishing country United States
    Document type Journal Article ; Randomized Controlled Trial ; Research Support, N.I.H., Intramural
    ZDB-ID 2958-0
    ISSN 1538-3598 ; 0254-9077 ; 0002-9955 ; 0098-7484
    ISSN (online) 1538-3598
    ISSN 0254-9077 ; 0002-9955 ; 0098-7484
    DOI 10.1001/jama.2012.28726
    Database MEDical Literature Analysis and Retrieval System OnLINE

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