Intracoronary Cardiac Progenitor Cells in Single Ventricle Physiology
| Autor: | Junko Kobayashi, Yosuke Kuroko, Daiki Ousaka, Hidemasa Oh, Maiko Kondo, Takahiro Eitoku, Shuhei Sato, Kenji Baba, Sadahiko Arai, Shuta Ishigami, Shunji Sano, Yasuhiro Kotani, Shinichi Ohtsuki, Takuya Goto, Shingo Kasahara, Tatsuo Iwasaki, Kenta Hirai, Naohiro Horio, Yoshihiko Kurita, Yosuke Fukushima |
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| Rok vydání: | 2017 |
| Předmět: |
0301 basic medicine
Cardiac function curve medicine.medical_specialty Heart disease Physiology business.industry 030204 cardiovascular system & hematology medicine.disease Hypoplastic left heart syndrome law.invention Clinical trial 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Randomized controlled trial Quality of life law Heart failure Internal medicine medicine Cardiology Risk of mortality Cardiology and Cardiovascular Medicine business |
| Zdroj: | Circulation Research. 120:1162-1173 |
| ISSN: | 1524-4571 0009-7330 0182-9750 |
| DOI: | 10.1161/circresaha.116.310253 |
| Popis: | Rationale: Patients with single ventricle physiology are at high risk of mortality resulting from ventricular dysfunction. The preliminary results of the phase 1 trial showed that cardiosphere-derived cells (CDCs) may be effective against congenital heart failure. Objective: To determine whether intracoronary delivery of autologous CDCs improves cardiac function in patients with single ventricle physiology. Methods and Results: We conducted a phase 2 randomized controlled study to assign in a 1:1 ratio 41 patients who had single ventricle physiology undergoing stage 2 or 3 palliation to receive intracoronary infusion of CDCs 4 to 9 weeks after surgery or staged reconstruction alone (study A). The primary outcome measure was to assess improvement in cardiac function at 3-month follow-up. Four months after palliation, controls had an alternative option to receive late CDC infusion on request (study B). Secondary outcomes included ventricular function, heart failure status, somatic growth, and health-related quality of life after a 12-month observation. At 3 months, the absolute changes in ventricular function were significantly greater in the CDC-treated group than in the controls (+6.4% [SD, 5.5] versus +1.3% [SD, 3.7]; P =0.003). In study B, a late CDC infusion in 17 controls increased the ventricular function at 3 months compared with that at baseline (38.8% [SD, 7.7] versus 34.8% [SD, 7.4]; P P P P P P =0.014) relative to baseline. Conclusions: Intracoronary infusion of CDCs after staged palliation favorably affected cardiac function by reverse remodeling in patients with single ventricle physiology. This impact may improve heart failure status, somatic growth, and quality of life in patients and reduce parenting stress for their families. Clinical Trial Registration: URL: http://www.clinicaltrials.gov . Unique identifier: NCT01829750. |
| Databáze: | OpenAIRE |
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