Phase II trial from 2015
SI is cherry picking data for the announcement. Read the whole article.
The FDA aren't going to buy it IMO.
https://www.ahajournals.org/doi/10....ri:rid:crossref.org&rfr_dat=cr_pub=pubmed
Left Ventricular Volumes
Volume measurements were obtained by 2D echocardiography. Compared with the control group, the 150 million MPC group showed improvement in LVESV with a statistically significant decrease at 6 months (
P=0.015) and
a nonsignificant decrease at 12 months (Online Table V). There were no statistically significant changes in LVESV in the other dose groups at any time point (Online Table V).
Figure 2 (top) shows the change from baseline in LVESV at 3, 6, and 12 months.
Similar to LVESV, there was a statistically significant decrease in LVEDV in the 150 million MPC group compared with control at 6 months (
P=0.020)
and a nonsignificant decrease at 12 months (Online Table V;
Figure 2, bottom).
There were no statistically significant changes in LVEDV in the other dose groups at any time point, except for an increase at 12 months in the 25 million MPC group (Online Table V).
Left Ventricular Ejection Fraction
Left ventricular systolic performance was evaluated serially by using 2D echocardiography (baseline, 3, 6, and 12 months; Online Table V) and MUGA (baseline and 6 months; Online Table VI). On echocardiography, LVEF increased significantly from baseline at 3 months in the 25 million MPC treatment group compared with control, but this difference was not maintained at follow-up. No significant differences from baseline were seen in the control or the 75 or 150 million MPC group at 3, 6, or 12 months.
MUGA results showed no significant differences in change from baseline at 6 months in control or any of the MPC-treated groups (Online Figure I).
Functional Exercise Capacity
The 150 million MPC group consistently showed nonsignificant improvement in functional exercise over time compared with the control group (Online Table VII). The control-corrected value for change from baseline at 12 months was 52.5 m (P=0.062) (Online Figure II). There were no statistically significant differences between the 25 or 75 million MPC treatment group and the control group in change from baseline in distance travelled (Online Figure II).
Other Efficacy Results
There were no consistent differences between the MPC-treated and control groups in myocardial perfusion by SPECT or in brain natriuretic peptide levels, New York Heart Association classification, or Minnesota Living with Heart Failure Questionnaire responses (Online Tables VIII–X).
(20min delay)