PMID- 19463392
OWN - NLM
STAT- MEDLINE
DCOM- 20100929
LR  - 20231024
IS  - 1876-7605 (Electronic)
IS  - 1936-8798 (Linking)
VI  - 2
IP  - 1
DP  - 2009 Jan
TI  - One-year follow-up of feasibility and safety of the first U.S., randomized, 
      controlled study using 3-dimensional guided catheter-based delivery of autologous 
      skeletal myoblasts for ischemic cardiomyopathy (CAuSMIC study).
PG  - 9-16
LID - 10.1016/j.jcin.2008.11.003 [doi]
AB  - OBJECTIVES: The aim of this study was to test safety and feasibility of myoblast 
      transplantation with the Biosense-NOGA (Diamond Bar, California) 
      3-dimensional-guided endomyocardial delivery system. BACKGROUND: Previous Phase-1 
      trials showed feasibility of epicardial injection of myoblasts. However, 
      catheter-based delivery has several advantages: it can be applied on high-risk 
      patients, the procedure can be repeated, and it is associated with less morbidity 
      and mortality. METHODS: Twenty-three subjects, with previous myocardial 
      infarction and heart failure, New York Heart Association (NYHA) functional class 
      II to IV, were enrolled, 11 control and 12 treatment subjects. To assess safety, 
      physical exam, electrocardiogram, continuous rhythm monitoring, quality of life 
      assessments, and heart function were evaluated at baseline and follow-up until 1 
      year. RESULTS: There was favorable safety: no difference between groups in 
      arrhythmias, and no deaths. Treated subjects showed sustained improvements in 
      NYHA and Minnesota Living with Heart Failure Questionnaire (MLHFQ) compared with 
      control subjects (NYHA, -1.0 point in treatment vs. +0.3 point in control group, 
      p < 0.0004; MLHFQ, -14 point in treatment vs. +1 point in the control group, p = 
      0.004). Blinded core laboratory echocardiography evaluations showed sustained 
      reductions in the treatment versus control in end diastolic diameter (-0.03 cm 
      vs. +0.05 cm, p = 0.07) and end systolic diameter (-0.05 cm vs. +0.1 cm, p = 
      0.07). Finally, NOGA voltage mapping demonstrated improved voltage measurements 
      (+1.0 mV, p = 0.008). CONCLUSIONS: This trial of myoblast transplantation via 
      catheter into heart failure patients demonstrated safety and feasibility. Treated 
      patients showed improvement in NYHA, MLHFQ, ventricular viability, and evidence 
      of reverse ventricular remodeling. These data demonstrate positive safety 
      outcomes and warrant initiation of larger phase 2, double-blind, 
      placebo-controlled clinical trials.
FAU - Dib, Nabil
AU  - Dib N
AD  - Clinical Cardiovascular Cell Therapy, University of California, San Diego, La 
      Jolla, California 92037-1300, USA. ndib@cardiostem.com
FAU - Dinsmore, Jonathan
AU  - Dinsmore J
FAU - Lababidi, Zaki
AU  - Lababidi Z
FAU - White, Bee
AU  - White B
FAU - Moravec, Susan
AU  - Moravec S
FAU - Campbell, Ann
AU  - Campbell A
FAU - Rosenbaum, Amy
AU  - Rosenbaum A
FAU - Seyedmadani, Katayoun
AU  - Seyedmadani K
FAU - Jaber, Wael A
AU  - Jaber WA
FAU - Rizenhour, Craig S
AU  - Rizenhour CS
FAU - Diethrich, Edward
AU  - Diethrich E
LA  - eng
PT  - Clinical Trial, Phase I
PT  - Journal Article
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
PL  - United States
TA  - JACC Cardiovasc Interv
JT  - JACC. Cardiovascular interventions
JID - 101467004
SB  - IM
MH  - Aged
MH  - Cardiomyopathy, Dilated/*therapy
MH  - Feasibility Studies
MH  - Female
MH  - Heart Failure/diagnostic imaging/*therapy
MH  - Heart Ventricles/pathology
MH  - Humans
MH  - Imaging, Three-Dimensional
MH  - Male
MH  - Middle Aged
MH  - Myoblasts, Skeletal/*transplantation
MH  - Quality of Life
MH  - Surveys and Questionnaires
MH  - Time Factors
MH  - Transplantation, Autologous
MH  - Ultrasonography
EDAT- 2009/05/26 09:00
MHDA- 2010/09/30 06:00
CRDT- 2009/05/26 09:00
PHST- 2008/05/05 00:00 [received]
PHST- 2008/10/14 00:00 [revised]
PHST- 2008/11/07 00:00 [accepted]
PHST- 2009/05/26 09:00 [entrez]
PHST- 2009/05/26 09:00 [pubmed]
PHST- 2010/09/30 06:00 [medline]
AID - S1936-8798(08)00479-2 [pii]
AID - 10.1016/j.jcin.2008.11.003 [doi]
PST - ppublish
SO  - JACC Cardiovasc Interv. 2009 Jan;2(1):9-16. doi: 10.1016/j.jcin.2008.11.003.