NCT04515537

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

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 15 (estimated)
• Sponsor: Sociedad Española de Medicina Regenerativa y Terapia Celular · Academic / Other
• Sex: All
• Age: 35 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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

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.

Conditions

• Congestive Heart Failure Chronic

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),	Patient use 2 capsules 3 time a day by oral.
PROCEDURE	Infiltrtion of SVf	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

Timeline

• Start date: 2021-05-20
• Primary completion: 2022-12-15
• Completion: 2023-09-30
• First posted: 2020-08-17
• Last updated: 2023-01-03

Locations

1 site across 1 country: Spain