This study is a prospective, randomized, controlled trial to assess the efficacy of transplantation of autologous stroma vauscultar fraction and/or AFA in 15 patients with ischemic heart failure
Stem cells therapy may be a choice therapy for advanced heart failure patients refractory to medical therapy, and a previous history of coronary artery diseases. In this study the investigators have evaluated consecutive 15 selected patients, the amelioration in failing heart NYHA class, hospitalization rate, echocardiographic left ventricle functionality, serum of Natriuretic peptide level and associated to reduction of angina after a treatment with stroma vascular fraction infusion y/or Stemregen capsule per oral.
Study Type
OBSERVATIONAL
Enrollment
15
Patient use 2 capsules 3 time a day by oral.
After filling up the informed consent Mini liposuction is performed under local anesthesia with klein solution, about 70 cc of dry fat tissue is suctioned and collagenase digestion is done with final centrifugation to obtain the SVF
Clinca Castello 68
Madrid, Spain
RECRUITINGChange NYHA functional class assessed with SAQ-7 -questionnaire
The improvement in patient's quality of life after 6 months of trial admission. The quality of life will be determined with Seattle Angina Questionnaire 7 (SAQ-7). Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality)
Time frame: 6 month
Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]
Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension. \[ Time Frame: 6 months from trial admission\]
Time frame: 6 months
Change NYHA functional class assessed with SAQ-7 -questionnaire
The improvement in patient's quality of life after 12 months of trial admission. The quality of life will be determined with Seattle Angina Questionnaire 7 (SAQ-7). Each domain has a score calculated on a scale of 0 (= worst health quality) to 100 (= best health quality).
Time frame: 12 months
Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ]
Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension, \[ Time Frame: 12 months from trial admission\]
Time frame: 12 months
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