Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure:A Phase II Danish Multicentre Study

Background. Ischemic heart failure (IHF) has a poor prognosis in spite of optimal therapy. We have established a new allogeneic Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors. It is produced without animal products, in closed bioreactor systems and cryopreserved as an off-the-shelf product ready to use. Study Design. A multicentre, double-blind, placebo-controlled phase II study with direct intramyocardial injections of allogeneic CSCC_ASC in patients with chronic IHF. A total of 81 patients will be randomised at 2 : 1 to CSCC_ASC or placebo. There is no HLA tissue type matching needed between the patients and the donors. Methods. The treatment will be delivered by direct injections into the myocardium. The primary endpoint is change in the left ventricle endsystolic volume at 6-month follow-up. Secondary endpoints are safety and changes in left ventricle ejection fraction, myocardial mass, stroke volume, and cardiac output. Other secondary endpoints are change in clinical symptoms, 6-minute walking test, and the quality of life after 6 and 12 months. Conclusion. The aim of the present study is to demonstrate safety and the regenerative efficacy of the allogeneic CSCC_ASC product from healthy donors in a double-blind, placebo-controlled, multicentre study in patients with IHF

Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study

Background. Ischemic heart failure (IHF) has a poor prognosis in spite of optimal therapy. We have established a new allogeneic Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors. It is produced without animal products, in closed bioreactor systems and cryopreserved as an off-the-shelf product ready to use. Study Design. A multicentre, double-blind, placebo-controlled phase II study with direct intramyocardial injections of allogeneic CSCC_ASC in patients with chronic IHF. A total of 81 patients will be randomised at 2 : 1 to CSCC_ASC or placebo. There is no HLA tissue type matching needed between the patients and the donors. Methods. The treatment will be delivered by direct injections into the myocardium. The primary endpoint is change in the left ventricle endsystolic volume at 6-month follow-up. Secondary endpoints are safety and changes in left ventricle ejection fraction, myocardial mass, stroke volume, and cardiac output. Other secondary endpoints are change in clinical symptoms, 6-minute walking test, and the quality of life after 6 and 12 months. Conclusion. The aim of the present study is to demonstrate safety and the regenerative efficacy of the allogeneic CSCC_ASC product from healthy donors in a double-blind, placebo-controlled, multicentre study in patients with IHF

Living with Atrial Fibrillation:A Family Perspective

AIM: The aim of this study was to obtain insights from patients and their family members on how families are living with atrial fibrillation. BACKGROUND: Atrial fibrillation is the most common cardiac arrhythmia and is often described as an emerging global epidemic affecting an estimated 33.5 million people worldwide. Living with atrial fibrillation not only affects the patient but also may negatively influence family members' perceived health. The perspective of the family has previously been understudied, and more knowledge on how patients and their family members cope and adjust to life with atrial fibrillation may be helpful when developing future support for patients and their family members when coping with atrial fibrillation. METHODS: A qualitative phenomenological study with an inductive, descriptive research approach based on Giorgi's descriptive method was used. Data were gathered through 12 dyadic family interviews. The COnsolidated criteria for REporting Qualitative research checklist was followed while conducting the study. RESULTS: Three major themes emerged: emotional differences, changes in family life, and uncertainty about the future. Atrial fibrillation had multiple effects on the family. Frequently, several adjustments and adaptations had to be made to accommodate life with atrial fibrillation. CONCLUSION: Patients with atrial fibrillation and their family members feel a need to talk about their emotions and worries. They required support and guidance to manage the challenges of living with atrial fibrillation. These results will be used in a family-focused intervention designed to support families in adjusting and managing their everyday lives with atrial fibrillation