Sustained effect of autologous bone marrow mononuclear cell injection in patients with refractory angina pectoris and chronic myocardial ischemia: twelve-month follow-up results.

BACKGROUND: Cell therapy has recently been introduced to treat patients with refractory angina. Because most studies have only included short-term follow-up, the effects of cell therapy over a longer period are unknown.

METHODS: In 25 patients (mean age 64 +/- 10 years, 21 men) with refractory angina, a total of 84 +/- 29 x 10(6) bone marrow-derived mononuclear cells was injected intramyocardially in regions with ischemia on technetium-99m tetrofosmin single-photon emission computed tomography. Anginal symptoms and quality of life were evaluated at baseline and at 3, 6, and 12 months. Gated single-photon emission computed tomography was performed at baseline and at 3 and 12 months to assess myocardial perfusion and left ventricular function.

RESULTS: Bone marrow cell injection was performed without any complication. At 7 months, one patient died of intracranial hemorrhage. Canadian Cardiovascular Society class improved from 3.4 +/- 0.5 to 2.3 +/- 0.6 at 3 months, 2.4 +/- 0.6 at 6 months, and 2.7 +/- 0.8 at 12 months (P < .01). Quality of life improved from 53% +/- 10% to 71% +/- 11% at 3 months, 72% +/- 14% at 6 months, and 68% +/- 14% at 12 months (P < .01). The number of segments with ischemia per patient decreased from 4.7 +/- 3.3 to 2.1 +/- 2.6 at 3 months and 1.6 +/- 2.5 at 12 months (P < .01). Left ventricular ejection fraction increased from 47% +/- 13% to 53% +/- 17% at 3 months and 51% +/- 17% at 12 months (P < .01). Regional wall motion improved from 5.9 +/- 1.7 to 6.6 +/- 2.2 mm at 3 months and 6.4 +/- 2.0 mm at 12 months (P = .01).

CONCLUSIONS: Autologous bone marrow cell injection in patients with ischemia is safe and results in a sustained beneficial effect on anginal symptoms, myocardial perfusion, and left ventricular function.