Study Study Design No of Patients Cell Dose Procedure Time Follow-Up Outcomes
[120] (TOPCARE-CHD Trial) Randomized, controlled n=28 BMNC; n=24 CirPC; n=23 Control 22x106 ± 11x106 CPCs; 205x106 ± 110x106 BMNCs ≥3 months post-MI 3 months No MACE from procedure. LVEF significantly improved in BMNC group only. No other functional benefit in either groups. Significant improvement in NYHA score in BMNC group only.
[112]   (STAR-heart Trial) Controlled n=191 BMNC; n=200 Control 6.6±3.3x107 8.5±3.2 years post-MI 5 years No MACE. Cell therapy significantly increased exercise capacity. Significant increase in LVEF & contractility with reduced infarct size in cell group. NYHA score significantly improved in cell group. Improvements maintained up to 5 years. Mortality rates significantly reduced in cell group at 5 years and significantly differed from controls.
(FOCUS-HF Trial)
Randomized, blinded, controlled n=20 BMNC; n=10 Control 2 million Not Stated  6 Months No MACE. Cell therapy had no significant effect on myocardial function. Downward trend in infarct size with cell therapy. QOL and CCS, but not NYHA scores significantly improved with cell therapy. BMNC dysfunction with presence of CHF and increased age (˃60 years).
BMNC bone-marrow mononuclear cells; CHF chronic heart failure; CirPC circulatory-derived progenitor cell; MI myocardial infarction; MACE major adverse cardiac event; LVEF left ventricular ejection fraction; NYHA New York heart association; QOL quality of life; CCS Canadian cardiovascular society
Table 5: Summary table of key trials utilizing direct transplantation of BMNCs in CHF.