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Effects of Transendocardial Delivery of Bone Marrow-Derived CD133+ Cells on Left Ventricle Perfusion and Function in Patients With Refractory Angina: Final Results of Randomized, Double-Blinded, Placebo-Controlled REGENT-VSEL Trial.
Wojakowski, Wojciech; Jadczyk, Tomasz; Michalewska-Wludarczyk, Aleksandra; Parma, Zofia; Markiewicz, Miroslaw; Rychlik, Wojciech; Kostkiewicz, Magdalena; Gruszczynska, Katarzyna; Blach, Anna; Dzier Zak-Mietla, Monika; Wanha, Wojciech; Ciosek, Joanna; Ochala, Beata; Rzeszutko, Lukasz; Cybulski, Wieslaw; Partyka, Lukasz; Zasada, Wojciech; Wludarczyk, Witold; Dworowy, Sebastian; Kuczmik, Waclaw; Smolka, Grzegorz; Pawlowski, Tomasz; Ochala, Andrzej; Tendera, Michal.
Affiliation
  • Wojakowski W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Jadczyk T; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Michalewska-Wludarczyk A; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Parma Z; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Markiewicz M; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Rychlik W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Kostkiewicz M; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Gruszczynska K; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Blach A; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Dzier Zak-Mietla M; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Wanha W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Ciosek J; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Ochala B; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Rzeszutko L; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Cybulski W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Partyka L; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Zasada W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Wludarczyk W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Dworowy S; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Kuczmik W; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Smolka G; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Pawlowski T; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Ochala A; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
  • Tendera M; From the Third Division of Cardiology (W.W., T.J., A.M.-W., Z.P., W.R., A.B., W.W., J.C., B.O., W.C., W.W., S.D., G.S., T.P., A.O., M.T.), Department of Hematology and Bone Marrow Transplantation (M.M., M.D.-M.), and Division of Diagnostic Imaging (K.G.), Medical University of Silesia, Katowice, Pol
Circ Res ; 120(4): 670-680, 2017 Feb 17.
Article in En | MEDLINE | ID: mdl-27903568
ABSTRACT
RATIONALE New therapies for refractory angina are needed.

OBJECTIVE:

Assessment of transendocardial delivery of bone marrow CD133+ cells in patients with refractory angina. METHODS AND

RESULTS:

Randomized, double-blinded, placebo-controlled trial enrolled 31 patients with recurrent Canadian Cardiovascular Society II-IV angina, despite optimal medical therapy, ≥1 myocardial segment with inducible ischemia in Tc-99m SPECT who underwent bone marrow biopsy and were allocated to cells (n=16) or placebo (n=15). Primary end point was absolute change in myocardial ischemia by SPECT. Secondary end points were left ventricular function and volumes by magnetic resonance imaging and angina severity. After 4 months, there were no significant differences in extent of inducible ischemia between groups (summed difference score mean [±SD] 2.60 [2.6] versus 3.63 [3.6], P=0.52; total perfusion deficit 3.60 [3.6] versus 5.01 [4.3], P=0.32; absolute changes of summed difference score -1.38 [5.2] versus -0.73 [1.9], P=0.65; and total perfusion deficit -1.33 [3.3] versus -2.19 [6.6], P=0.65). There was a significant reduction of left ventricular volumes (end-systolic volume -4.3 [11.3] versus 7.4 [11.8], P=0.02; end-diastolic volume -9.1 [14.9] versus 7.4 [15.8], P=0.02) and no significant change of left ventricular ejection fraction in the cell group. There was no difference in number of patients showing improvement of ≥1 Canadian Cardiovascular Society class after 1 (41.7% versus 58.3%; P=0.68), 4 (50% versus 33.3%; P=0.63), 6 (70% versus 50.0%; P=0.42), and 12 months (55.6% versus 81.8%; P=0.33) and use of nitrates after 12 months.

CONCLUSION:

Transendocardial CD133+ cell therapy was safe. Study was underpowered to conclusively validate the efficacy, but it did not show a significant reduction of myocardial ischemia and angina versus placebo. CLINICAL TRIAL REGISTRATION URL http//www.clinicaltrials.gov. Unique identifier NCT01660581.
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Full text: 1 Database: MEDLINE Main subject: Ventricular Function, Left / Bone Marrow Transplantation / Endocardium / AC133 Antigen / Angina Pectoris Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Circ Res Year: 2017 Type: Article
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Full text: 1 Database: MEDLINE Main subject: Ventricular Function, Left / Bone Marrow Transplantation / Endocardium / AC133 Antigen / Angina Pectoris Type of study: Clinical_trials / Observational_studies / Prognostic_studies / Risk_factors_studies Limits: Aged / Female / Humans / Male / Middle aged Country/Region as subject: America do norte Language: En Journal: Circ Res Year: 2017 Type: Article