Objectives: Short-term follow-up after autologous skeletal myoblasts (ASM) transplantation (Tx) (Myoblast Autologous Grafting in Ischaemic Cardiomyopathy (MAGIC) Phase II Study) for the treatment of ischaemic cardiomyopathy revealed improved left ventricular (LV) remodelling. Our study reports the longest long-term worldwide follow-up of a single-centre cohort, focusing on the safety and efficacy of ASM-Tx.
Methods: The multicentre MAGIC Phase II Study involved 120 patients and was conducted between 2004 and 2006. Out of the 120 patients involved in the entire study, the cohort treated at our institution contained 7 patients only. These 7 patients received ASM-Tx (injection volume: 400 million cells, n = 2 low dosage; 800 million cells, n = 2 high dosage) or placebo (n = 3) injections, in addition to coronary artery bypass grafting (CABG). After closure of the MAGIC registry, we conducted a long-term follow-up for our 7-patient cohort. The mean follow-up was 72.0 ± 5.3 months. The follow-up was complete for echo data, implanted cardioverter defibrillator (ICD) report, clinical investigation and New York Heart Association (NYHA) class.
Results: At final follow-up, all the patients were alive, and 5 were in NYHA class 1 or 2. There were 6 hospitalizations for congestive heart failure during the follow-up (1 patient from each group). One patient (placebo group) was treated twice for ventricular fibrillation by the ICD. The LV ejection fraction remained stable in all the three groups (31.1 ± 3.9% preoperative vs 29.4 ± 4.4% at final follow-up). The LV volumes were reduced in the high-dosage group, remained unchanged in the low-dosage group and deteriorated in the placebo group.
Conclusions: Our long-term data confirm the findings of the MAGIC study. The LV function did not improve, but the long-term LV volumes in the high-dosage group were reduced. During the follow-up, there were also no additional arrhythmogenic incidences. Our data could imply that CABG in combination with ASM-Tx is safe and has beneficial therapeutic effects in the long-term. However, due to the small patient number, the clinical impact is limited.
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http://dx.doi.org/10.1093/icvts/ivt434 | DOI Listing |
Clin Trials
January 2025
Department of Biostatistics, University of Florida, Gainesville, FL, USA.
Introduction: The sequential parallel comparison design has emerged as a valuable tool in clinical trials with high placebo response rates. To further enhance its efficiency and effectiveness, adaptive strategies, such as sample size adjustment and allocation ratio modification can be employed.
Methods: We compared the performance of Jennison and Turnbull's method and the Promising Zone approach for sample size adjustment in a two-phase sequential parallel comparison design study.
Ocul Immunol Inflamm
January 2025
Ocular Oncology Service, Institute of Oncology, Tecnologico de Monterrey, Monterrey, Mexico.
Purpose: To present the case of a young patient with BRAF V600E-mutant cutaneous melanoma who developed bilateral choroidal metastases complicated by neovascular glaucoma (NVG) in both eyes following the interruption of nivolumab therapy.
Methods: A 28-year-old female with primary cutaneous melanoma of the left hand underwent surgical resection and adjuvant nivolumab. Immunotherapy was discontinued due to immune-related acute interstitial nephritis.
Br J Hosp Med (Lond)
January 2025
Nursing Department, Zhang Ye People's Hospital Affiliated to Hexi University, Zhangye, Gansu, China.
Diabetes is a chronic lifelong condition that requires consistent self-care and daily lifestyle adjustments. Effective disease management involves regular blood glucose monitoring and ongoing nursing support. Inadequate education and poor self-management are key factors contributing to increased mortality among diabetic individuals.
View Article and Find Full Text PDFInt J Gynaecol Obstet
January 2025
Department of Obstetrics and Gynaecology, Aga-Khan University of Hospital, Nairobi, Kenya.
Placenta accreta spectrum (PAS) poses a significant risk for maternal morbidity and mortality. There is a global rise in incidence of PAS in tandem with an increase in rates of cesarian section. Previous cesarian section and presence of placenta previa are two independent risk factors for development of PAS.
View Article and Find Full Text PDFInt J Gynaecol Obstet
January 2025
Division of Gynecologic Oncology, Jewish General Hospital, McGill University, Montreal, Quebec, Canada.
Objective: The objective of this paper is to study the association between obesity and tumor recurrence in patients with vulvar cancer.
Methods: This is a retrospective study including vulvar cancer patients from 2003 to 2022. Our primary outcome was progression-free survival (PFS) stratified by status of obesity, defined as body mass index (BMI) >30.
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