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

December 29, 2022 updated by: Sociedad Española de Medicina Regenerativa y Terapia Celular

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Madrid, Spain, 28001
        • Recruiting
        • Clinca Castello 68
        • Contact:
        • Contact:
          • Felix Pedrero, MD
          • Phone Number: 34 622411766
        • Principal Investigator:
          • Christian Drapeau, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

35 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

15 patients age from 35 to 80 yers old

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
conventional therapy plus AFA
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),
Patient use 2 capsules 3 time a day by oral.
conventional therapy plus SVF
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
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
conventional therapy plus SVF and AFA
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),
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change NYHA functional class assessed with SAQ-7 -questionnaire
Time Frame: 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)
6 month
Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]
Time Frame: 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
Time Frame: 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).
12 months
Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ]
Time Frame: 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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sociedad Española de Medicina Regenerativa y Terapia Celular

Collaborators

Clinica Castello 68

Investigators

  • Principal Investigator: Miguel G Garber, MD, Healthy Longevity Clinic
  • Study Director: Christian Drapeau, PhD, Kalyagen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 20, 2021

Primary Completion (Actual)

December 15, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

January 3, 2020

First Submitted That Met QC Criteria

August 14, 2020

First Posted (Actual)

August 17, 2020

Study Record Updates

Last Update Posted (Actual)

January 3, 2023

Last Update Submitted That Met QC Criteria

December 29, 2022

Last Verified

December 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD, all IPD that underlie results in a publication

IPD Sharing Time Frame

15 months to 3 years

IPD Sharing Access Criteria

Undecided

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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