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Objective: The regenerative potential of bone marrow-derived mononuclear cells [MNCs] and CD133+ stem cells in the heart varies in terms of their pro-angiogenic effects. This phase II/III, multicenter and double-blind trial is designed to compare the functional effects of intramyocardial autologous transplantation of both cell types and placebo in patients with recent myocardial infarction [RMI] post-coronary artery bypass graft
Materials and Methods: This was a phase II/III, randomized, double-blind, placebo-controlled trial COMPARE CPM-RMI [CD133, Placebo, MNCs - recent myocardial infarction] conducted in accordance with the Declaration of Helsinki that assessed the safety and efficacy of CD133 and MNCs compared to placebo in patients with RMI. We randomly assigned 77 eligible RMI patients selected from 5 hospitals to receive CD133+ cells, MNC, or a placebo. Patients underwent gated single photon emission computed tomography assessments at 6 and 18 months post-intramyocardial transplantation. We tested the normally distributed efficacy outcomes with a mixed analysis of variance model that used the entire data set of baseline and between-group comparisons as well as within subject [time] and group×time interaction terms
Results: There were no related serious adverse events reported. The intramyocardial transplantation of both cell types increased left ventricular ejection fraction by 9% [95% confidence intervals [CI]: 2.14% to 15.78%, P=0.01] and improved decreased systolic wall thickening by -3.7 [95% CI: -7.07 to -0.42, P=0.03]. The CD133 group showed significantly decreased non-viable segments by 75% [P=0.001] compared to the placebo and 60% [P=0.01] compared to the MNC group. We observed this improvement at both the 6- and 18-month time points
Conclusion: Intramyocardial injections of CD133+ cells or MNCs appeared to be safe and efficient with superiority of CD133+ cells for patients with RMI. Although the sample size precluded a definitive statement about clinical outcomes, these results have provided the basis for larger studies to confirm definitive evidence about the efficacy of these cell types
RESUMO
L,L-ethylenedicysteine [EC] is a new carrier of technetium Tc 99m [99mTc] with a lower affinity to plasma albumin in comparison with diethylenetriamine pentaacetic acid [DTPA]. We compared 99mTc-EC scan with 99mTc-DTPA scan in diuretic renography for patients with obstructive uropathy. Thirty-three patients with upper urinary tract obstruction were randomly selected and underwent diuretic renographies by 99mTc-EC and 99mTc-DTPA. The counts of radioisotope per pixel in the target [the kidney] and background tissues as well as the clearance half-life of these two radiopharmaceuticals were measured and compared. Mean counts of radioisotope per pixel in the target tissue was not different between 99mTc-EC and 99mTc-DTPA scans, but in the background tissue, it was less for 99mTc-EC [P =.003]. Target-background ratio was higher for 99mTc-EC scan [3.80 +/- 2.11 versus 2.48 +/- 1.39; P <.001]. Renal clearance half-life of radioisotope was shorter for 99mTc-EC scan than 99mTc-DTPA scan [58.15 +/- 15.17 minutes versus 78.65 +/- 19.99 minutes; P =.033]. The results were similar for uremic patients [with a serum creatinine level > 2mg/dL]. Target-background ratio of radiopharmaceutical uptake rates in diuretic renography was a good indicator of the higher resolution of 99mTc-EC than 99mTc-DTPA scan. We also demonstrated the faster clearance of 99mTc-EC than 99mTc-DTPA. This results in less radiation that is especially useful in children. To our opinion, 99mTc-EC can better depict the kidneys in comparison with 99mTc-DTPA