2025-520837-22-00招募中2 期
A Danish, double-blind, randomized placebo-controlled clinical trial evaluating allogeneic adipose tissue derived mesenchymal stromal cell therapy in patients with recently diagnosed non-ischemic heart failure with reduced ejection fraction.
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 4
- 主要终点
- The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion.
研究概览
简要总结
To investigate efficacy and safety of intravenous infusion of allogeneic adipose tissue-derived mesenchymal stromal stem cells (C2C_ASC110) in patients with recently diagnosed non-ischemic heart failure in restoring cardiac function compared to placebo (CryoStor CS10).
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •> 18 years of age
- •Diagnosed with non-ischemic heart failure with initial LVEF (left ventricular ejection fraction) ≤ 40% and then up-titrated to maximal tolerable heart failure medication within the last 12 months
- •Symptomatic heart failure (NYHA II-III)
- •LVEF ≤ 45% documented by echocardiography, CT or MRI performed after up-titration of heart failure medication (documentation of reduced LVEF at least after 1 and 3 months if implantation of a device either an Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronisation Therapy (CRT), respectively)
- •Plasma Pro-BNP > 300 pg/ml (> 35 pmol/L) in patients with sinus rhyth and plasma Pro BNP > 422 pg/ml (> 49 pmol/L) in patients with atrial fibrillation
排除标准
- •NYHA I or IV heart failure
- •Diminished functional capacity for other reasons such as: chronic obstructive pulmonary disease (COPD) with forced expiratory volume (FEV) < 1 L/min or body mass index > 35kg/m^2
- •Clinically significant anaemia (haemoglobin < 6 mmol/L), leukopenia (leucocytes < 2x10^9/L), leucocytosis (leucocytes >14x10^9/L) or thrombocytopenia (thrombocytes < 50x10^9/L)
- •History with malignant disease within five years of inclusion or current suspected malignancy – except treated skin cancer other than melanoma
- •Patients with known hypersensitivity to DMSO and Dextran-40
- •Pregnant women
- •Documented ischemic heart failure
- •Ongoing alcohol abuse
- •Implantation of CRT within 3 months or ICD within 1 month
- •Acute coronary syndrome with elevation of CKMB (Creatine Phosphatase-Myocardial Band) or troponins, stroke or transitory cerebral ischemia within six weeks of inclusion
- •Expected to undergo screening for heart transplantation during the study time
- •Listed for heart transplantation
- •Other cardiac revascularization treatments to be performed
- •Moderate to severe aortic stenosis (valve area < 1.1 cm2) or clinically significant mitral valve disease
结局指标
主要结局
The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion.
The primary efficacy endpoint is change in LVEF 6 months after last C2C_ASC110 infusion compared to the patient group treated with placebo (CryoStor CS10) infusion.
次要结局
- The secondary efficacy endpoint are changes in LVESV (left ventricular end-systolic volume), LVEF and LVEDV (left ventricular end-diastolic volume) at 7 and 12 months follow-up.
- Other secondary efficacy endpoints: changes in; NYHA classification; 6-minute walking test; KCCQ and EQ5D5L questionnaire; additional echocardiographic measures and Pro-BNP
- Safety endpoints are: incidence and severity of SARs (serious adverse reactions) and SUSARs (suspected unexpected serious adverse reactions) evaluated at 12 months follow-up
研究者
Jens Kastrup
Scientific
Cell2Cure ApS
研究点 (4)
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