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

Sociedad Española de Medicina Regenerativa y Terapia Celular

Status: Enrolling

Conditions: Congestive Heart Failure Chronic

Treatments: Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),; Procedure: Infiltrtion of SVf

Study type: Observational

Funder types: Other

Identifiers

NCT04515537

13245

Details and patient eligibility

About

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

Full description

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 35 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

15 participants in 3 patient groups

conventional therapy plus AFA

Description:

Patient using conventional therapy plus Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), for a period of 6 months

Treatment:

Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),

conventional therapy plus SVF

Description:

Patient using conventional therapy plus aplication of stroma vascular fraction (SVF) from the adipose tissue, evaluted for period of 6 months

Treatment:

Procedure: Infiltrtion of SVf

conventional therapy plus SVF and AFA

Description:

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

Treatment:

Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),

Procedure: Infiltrtion of SVf