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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.
- Source :
-
Circulation research [Circ Res] 2017 Feb 17; Vol. 120 (4), pp. 670-680. Date of Electronic Publication: 2016 Nov 30. - Publication Year :
- 2017
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Abstract
- Rationale: New therapies for refractory angina are needed.<br />Objective: Assessment of transendocardial delivery of bone marrow CD133 <superscript>+</superscript> cells in patients with refractory angina.<br />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.<br />Conclusion: Transendocardial CD133 <superscript>+</superscript> 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.<br />Clinical Trial Registration: URL: http://www.clinicaltrials.gov. Unique identifier: NCT01660581.<br /> (© 2016 American Heart Association, Inc.)
- Subjects :
- Aged
Angina Pectoris epidemiology
Bone Marrow Cells physiology
Canada epidemiology
Double-Blind Method
Endocardium cytology
Female
Follow-Up Studies
Humans
Magnetic Resonance Imaging methods
Male
Middle Aged
Prospective Studies
Tomography, Emission-Computed, Single-Photon methods
Transplantation, Autologous methods
Treatment Outcome
AC133 Antigen administration & dosage
Angina Pectoris diagnostic imaging
Angina Pectoris therapy
Bone Marrow Transplantation methods
Endocardium physiology
Ventricular Function, Left physiology
Subjects
Details
- Language :
- English
- ISSN :
- 1524-4571
- Volume :
- 120
- Issue :
- 4
- Database :
- MEDLINE
- Journal :
- Circulation research
- Publication Type :
- Academic Journal
- Accession number :
- 27903568
- Full Text :
- https://doi.org/10.1161/CIRCRESAHA.116.309009