Cyanophyta Aphanizomenon Flos-aquae, and Adipose Stroma Vascular Fraction, in Heart Failure Patient

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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The Effect of Cyanophyta Aphanizomenon Flos-aquae (Stemregen), and Adipose Stroma Vascular Fraction (SVF) Either Individual or in Combination in Patient With Heart Failure

Conditions
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Congestive Heart Failure Chronic

Intervention / Treatment
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* Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),
* Procedure: Infiltrtion of SVf


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: EF < 45 % NYHA 2 - 3 Exclusion Criteria: Acute coronary syndrome within last 6 weeks. Pregnancy FEV1 <20 % Cancer Any severe disease which could interfere with the treatment or the outcome Patient with immunodeficiency Candidate who are judged to be not applicable to this study by doctors.

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| conventional therapy plus AFA<br>Patient using conventional therapy plus Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), for a period of 6 months | Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),<br>* Patient use 2 capsules 3 time a day by oral.<br>|
| conventional therapy plus SVF<br>Patient using conventional therapy plus aplication of stroma vascular fraction (SVF) from the adipose tissue, evaluted for period of 6 months | Procedure: Infiltrtion of SVf<br>* 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<br>|
| conventional therapy plus SVF and AFA<br>Patient using conventional therapy plus aplication of stroma vascular fraction (SVF) from the adipose tissue plus Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), for a period of 6 months | Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),<br>* Patient use 2 capsules 3 time a day by oral.<br>Procedure: Infiltrtion of SVf<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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) | 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] | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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). | 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] | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem Cell, AFA, Heart Failure, Stroma vascular fraction