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Cardiac Cell Therapy Network | RFA

This initiative involves investigators from multiple departments, including Medicine, Pathology, Cardiac Surgery, and Pediatrics.

Biostatisticians: Cindy Chen, Frank Harrell

Background

  • RFA for Stem cell tx for cv disease
  • LV dysfunction patients undergoing device tx
  • Network of 5 clinical centers (VU applying for one), one DCC
  • Demo experience in multi-center trials
  • Commit to disseminate results
  • Phase I/II studies
  • Sample size calculations
  • Will choose 2 protocols
  • $300K/yr including co-Is at >= 10% FTE
  • Development core for young clinical investigators
  • 2 page proposal by 27Jan06 describing 2 protocols with sample sizes
  • Main proposal 10Mar06 if first one accepted

Goals

  • Cell delivery
  • ID cell types for tx
  • Track cells, standardize cell/tx procedures
  • Evaluate patient groups
  • Define endpoints
  • Knowledge base for tx decisions
  • Dissemination and training

Possible Endpoints

Physiologic

  • Exercise capacity
  • Hemodynamics
  • Health/function survey
  • HRV (non-specific but sensitive)

Ventricular Structure/Function

  • MRI (gold standard but can't use in ICD or pacemaker patients)
  • 3d Echo (tissue Doppler)
  • RVG (MUGA), (LVEF, regional EF, LV volume)
  • Contractile reserve (LVSWI, stress LV function)

Cell Survival

  • Biomarkers
  • PET scan (metabolism)
  • MRI

Biochemical

  • BND, TNF, CMP

Electrical

  • EKG
  • Holter/event monitorhtthttp://www.cnn.com/http://www.cnn.com/http://www.cnn.com/p://www.cnn.com/
  • Signal-averaged EKG

Experimental Designs

Protocol 2

P with GCSF BM Control
IM Per Im Per  
N N N
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Topic revision: r1 - 17 Dec 2005, FrankHarrell
 

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