Randomised trial of combination cytokine and adult autologous bone marrow progenitor cell administration in patients with non-ischaemic dilated cardiomyopathy - the regenerate-dcm randomized phase II
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Volume
36
Pagination
1190 - 1190
Publisher
DOI
10.1093/eurheartj/ehv390
Journal
EUROPEAN HEART JOURNAL
ISSN
0195-668X
Metadata
Show full item recordAbstract
The REGENERATE-DCM trial is the first phase II randomized, placebo-controlled trial aiming to assess if granulocyte
colony-stimulating factor (G-CSF) administration with or without adjunctive intracoronary (IC) delivery of autologous
bone marrow-derived cells (BMCs) improves global left ventricular (LV) function in patients with dilated cardiomyopathy (DCM) and significant cardiac dysfunction.
Methods
and results
Sixty patients with DCM and left ventricular ejection fraction (LVEF) at referral of ≤45%, New York Heart Association
(NYHA) classification ≥2 and no secondary cause for the cardiomyopathy were randomized equally into four groups:
peripheral placebo (saline), peripheral G-CSF, peripheral G-CSF and IC serum, and peripheral G-CSF and IC BMC. All
patients, except the peripheral placebo group, received 5 days of G-CSF. In the IC groups, this was followed by bone
marrow harvest and IC infusion of cells or serum on Day 6. The primary endpoint was LVEF change from baseline to
3 months, determined by advanced cardiac imaging. At 3 months, peripheral G-CSF combined with IC BMC therapy
was associated with a 5.37% point increase in LVEF (38.30%+12.97 from 32.93%+16.46 P ¼ 0.0138), which was
maintained to 1 year. This was associated with a decrease in NYHA classification, reduced NT-pro BNP, and improved
exercise capacity and quality of life. No significant change in LVEF was seen in the remaining treatment groups.
Conclusion This is the first randomized, placebo-controlled trial with a novel combination of G-CSF and IC cell therapy that
demonstrates an improvement in cardiac function, symptoms, and biochemical parameters in patients with DCM.
Authors
Hamshere, S; Arnous, S; Choudhury, T; Choudry, FA; Jones, D; Agrawal, S; Martin, J; Mathur, ACollections
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