Abstract
Background: Although pre-clinical researches proved that cardiac regenerative therapy with autologous skeletal stem cell (SSC) patch implantation healed non-ischemic dilated cardiomyopathy (NIDCM) animal model by anti-fibrotic effect and preservation of cytoskeletal proteins in distressed myocytes, its clinical effectiveness for NIDCM has not been clearly elucidated. We hypotheses SSC patch implantation for NIDCM is feasible, safe and have therapeutic efficacy and we aim to identify the predictor of responder of this treatment in NIDCM patients Methods: Twenty-four NIDCM patients with ejection fraction less than 35% underwent SSC patch transplantation (average: 3.9±0.4х10 8 cells) via the left thoracotomy without concomitant procedures. We identified thirteen responders (Group RP) and eleven non-responders (Group NR) using the combined indicator of major cardiac adverse event and incidence of heart failure event. Results: In Group RP, symptoms, exercise capacity and cardiac performance were improved postoperatively (NYHA functional class; 2.5±0.5 to 1.9±0.3, p<0.05, six-minute walk test; 471(370-541) to 525(425-555)m, p<0.05, LVSWI; 31.1(22.7-35.5) to 32.8(28-38.5)g/m 2 /beat, p=0.21). However, such improvement was not observed in Group NR. Overall survival rate was 90.9±8.7% at 5 years, which was superior to estimated survival rate using Seattle heart failure model (SHFM) of 70.9±5.4% in Group RP. However overall and estimated survival rate using SHFM was similar in Group NR (47.7±21.6% and 56.3±8.1%). Preoperative histological analysis demonstrated significant low level of hypertrophy of myocyte and interstitial fibrosis and high expression of histone methylation-related molecules in Group RP compared with Group NR. Multivariate regression model with BNP, PCWP and expression of histone H3 lysine 4 trimethylation (H3K4me3) strongly predicted the responder (BNP: OR 0.96, PCWP: OR, 0.58, H3K4me3; OR, 1.35, AUC in ROC, 0.96, p<0.001). Conclusions: This clinical trial demonstrated that SSC patch implantation might promise functional recovery and good clinical outcome in selected NIDCM patients with preoperatively preserved diastolic function and ability of protein synthesis in myocytes.
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