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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04515537

Enrollment

Registered

2020-08-17

Start date

2021-05-20

Completion date

2023-09-30

Last updated

2023-01-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Congestive Heart Failure Chronic

Keywords

Heart Failure, Stem Cell, Stroma vascular fraction, AFA

Brief 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.

Interventions

DIETARY_SUPPLEMENTWater-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),

Patient use 2 capsules 3 time a day by oral.

PROCEDUREInfiltrtion 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

Study design

Observational model

COHORT

Time perspective

CROSS_SECTIONAL

Eligibility

Sex/Gender

ALL

Age

35 Years to 80 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Change NYHA functional class assessed with SAQ-7 -questionnaire	6 month	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)
Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]	6 months	Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension. \[ Time Frame: 6 months from trial admission\]

Secondary

Measure	Time frame	Description
Change NYHA functional class assessed with SAQ-7 -questionnaire	12 months	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).
Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ]	12 months	Left Ventricular end-systolic volume index (LVESVI) Left Ventricular end-systolic dimension Left Ventricular end-diastolic volume Left Ventricular end-diastolic dimension, \[ Time Frame: 12 months from trial admission\]

Countries

Spain

Contacts

Primary ContactMiguel G Garber, MD

mggarber@gmail.com34 628766753

Backup ContactFelix Pedrero, MD

consulta@doctorpedrero.com34 622411766

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026