Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04515537
Recruitment Status : Recruiting
First Posted : August 17, 2020
Last Update Posted : April 20, 2021
Sponsor:
Information provided by (Responsible Party):
Sociedad Española de Medicina Regenerativa y Terapia Celular

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

Condition or disease Intervention/treatment
Congestive Heart Failure Chronic Dietary Supplement: Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), Procedure: Infiltrtion of SVf

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.

Layout table for study information
Study Type : Observational
Estimated Enrollment : 15 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: The Effect of Cyanophyta Aphanizomenon Flos-aquae (Stemregen), and Adipose Stroma Vascular Fraction (SVF) Either Individual or in Combination in Patient With Heart Failure
Estimated Study Start Date : May 20, 2021
Estimated Primary Completion Date : December 15, 2021
Estimated Study Completion Date : March 30, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

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




Primary Outcome Measures :
  1. 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)

  2. 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]


Secondary Outcome Measures :
  1. 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).

  2. 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]



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   35 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
15 patients age from 35 to 80 yers old
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04515537


Contacts
Layout table for location contacts
Contact: Miguel G Garber, MD 34 628766753 mggarber@gmail.com
Contact: Felix Pedrero, MD 622411766 consulta@doctorpedrero.com

Locations
Layout table for location information
Spain
Clinca Castello 68 Recruiting
Madrid, Spain, 28001
Contact: Miguel G Garber, MD    34 628766753    mggarber@gmail.com   
Contact: Felix Pedrero, MD    34 622411766      
Principal Investigator: Christian Drapeau, PhD         
Sponsors and Collaborators
Sociedad Española de Medicina Regenerativa y Terapia Celular
Investigators
Layout table for investigator information
Principal Investigator: Christian Drapeau, PhD Semeretec
Publications:

Layout table for additonal information
Responsible Party: Sociedad Española de Medicina Regenerativa y Terapia Celular
ClinicalTrials.gov Identifier: NCT04515537    
Other Study ID Numbers: 13245
First Posted: August 17, 2020    Key Record Dates
Last Update Posted: April 20, 2021
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all collected IPD, all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Time Frame: 15 months to 3 years
Access Criteria: Undecided

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sociedad Española de Medicina Regenerativa y Terapia Celular:
Heart Failure
Stem Cell
Stroma vascular fraction
AFA
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases