Transcoronary sinus administration of autologous bone marrow in patients with chronic refractory stable angina Phase 1.
OBJECTIVE
Based on our preclinic studies with autologous unfractionated bone marrow (AUBM) via coronary sinus with transitory occlusion, a clinic study in patients with chronic stable angina was designed. The objectives were to evaluate safety, tolerance and feasibility.


METHODS
A multicenter prospective study with inclusion and exclusion criteria defined by an Independent Clinical Committee was carried out. Fourteen patients underwent transcoronary sinus administration of freshly aspirated and filtered AUBM (60-120 ml). Safety and tolerance were evaluated. Feasibility was evaluated with Seattle Angina Questionnaire (SAQ), Canadian Cardiovascular Society (CCS) angina classification (baseline-Day 180), myocardial perfusion (baseline-Day 90) with independent core laboratory and coronary angiography (baseline and Day 30).


RESULTS
There were no changes in the safety and tolerance parameters. Preliminary clinical efficacy at Day 180 disclosed a significant improvement of 38%, evaluated by the SAQ. The CCS angina classification shows that the mean angina class was 3.0+/-0.55 at baseline and improved to 2.0+/-0.00 at Day 180 (P <.001). Semiquantitative radionuclide perfusion imaging (core lab) showed a significant improvement at Day 90 in 13/14 patients, with a mean improvement of 24% at rest (P <.01) and 33% at stress (P <.05). Coronary angiography showed more collateral vessels in 9/14 patients.


CONCLUSIONS
We can conclude that AUBM via coronary sinus with transitory occlusion is tolerable and safe. Significant improvement in the myocardial perfusion at Day 90 and in the quality of life at Day 180 was observed.
J.B. Iturraspe Hospital, Santa Fe 3000, Argentina. josevicario@hotmail.com
J
J
Vicario
C
C
Campos
J
J
Piva
F
F
Faccio
L
L
Gerardo
C
C
Becker
H H
HH
Ortega
A
A
Pierini
C
C
Lofeudo
R
R
Novero
A
A
Licheri
R
R
Milesi
N
N
Perez Baliño
A
A
Monti
A
A
Amin
H
H
Pfeiffer
E
E
De Giovanni
I
I
Fendrich
D000787:Angina Pectoris / Q000150:complications / Q000628:therapy*; D016026:Bone Marrow Transplantation / Q000009:adverse effects / Q000379:methods*; D002908:Chronic Disease; D017023:Coronary Angiography / Q000379:methods; D003324:Coronary Artery Disease / Q000150:complications; D003326:Coronary Circulation; D003331:Coronary Vessels; D005240:Feasibility Studies; D005260:Female; D006321:Heart / Q000000981:diagnostic imaging; D006801:Humans; D008297:Male; D008875:Middle Aged; D010865:Pilot Projects; D011446:Prospective Studies; D015899:Tomography, Emission-Computed, Single-Photon / Q000379:methods; D014182:Transplantation, Autologous; D016896:Treatment Outcome