Combined delivery approach of bone marrow mononuclear stem cells early and late after myocardial infarction: the MYSTAR prospective, randomized study.
BACKGROUND
Combined intracoronary and intramyocardial administration might improve outcomes for bone-marrow-derived stem cell therapy for acute myocardial infarction (AMI). We compared the safety and feasibility of early and late delivery of stem cells with combined therapy approaches.


METHODS
Patients with left ventricular ejection fraction less than 45% after AMI were randomly assigned stem cell delivery via intramyocardial injection and intracoronary infusion 3-6 weeks or 3-4 months after AMI. Primary end points were changes in infarct size and left ventricular ejection fraction 3 months after therapy.


RESULTS
A total of 60 patients were treated. The mean changes in infarct size at 3 months were -3.5 +/- 5.1% (95% CI -5.5% to -1.5%, P = 0.001) in the early group and -3.9 +/- 5.6% (95% CI -6.1% to -1.6%, P = 0.002) in the late group, and changes in ejection fraction were 3.5 +/- 5.6% (95% CI 1.3-5.6%, P = 0.003) and 3.4 +/- 7.0% (95% CI 0.7-6.1%, P = 0.017), respectively. At 9-12 months after AMI, ejection fraction remained significantly higher than at baseline in both groups. In the early and late groups, a mean of 200.3 +/- 68.7 x 10(6) and 194.8 +/- 60.4 x 10(6) stem cells, respectively, were delivered to the myocardium, and 1.30 +/- 0.68 x 10(9) and 1.29 +/- 0.41 x 10(9) cells, respectively, were delivered into the artery. A high number of cells was required for significant improvements in the primary end points.


CONCLUSIONS
Combined cardiac stem cell delivery induces a moderate but significant improvement in myocardial infarct size and left ventricular function.
Gyöngyösi
Mariann
M
Department of Cardiology, Medical University of Vienna, Austria. mariann.gyongyosi@meduniwien.ac.at
Lang
Irene
I
Dettke
Markus
M
Beran
Gilbert
G
Graf
Senta
S
Sochor
Heinz
H
Nyolczas
Noémi
N
Charwat
Silvia
S
Hemetsberger
Rayyan
R
Christ
Günter
G
Edes
István
I
Balogh
László
L
Krause
Korff Thomas
KT
Jaquet
Kai
K
Kuck
Karl-Heinz
KH
Benedek
Imre
I
Hintea
Theodora
T
Kiss
Róbert
R
Préda
István
I
Kotevski
Vladimir
V
Pejkov
Hristo
H
Zamini
Sholeh
S
Khorsand
Aliasghar
A
Sodeck
Gottfried
G
Kaider
Alexandra
A
Maurer
Gerald
G
Glogar
Dietmar
D
D000328:Adult; D000368:Aged; D016026:Bone Marrow Transplantation; D005060:Europe; D005240:Feasibility Studies; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009203:Myocardial Infarction / Q000473:pathology / Q000503:physiopathology / Q000601:surgery*; D009206:Myocardium / Q000473:pathology*; D011446:Prospective Studies; D016037:Single-Blind Method; D033581:Stem Cell Transplantation; D013318:Stroke Volume; D013997:Time Factors; D015899:Tomography, Emission-Computed, Single-Photon; D016896:Treatment Outcome; D016277:Ventricular Function, Left