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

NCT04515537 | Unknown DMC

• 1 other identifier: 13245
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

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

Conditions

Congestive Heart Failure Chronic

Keywords

Heart Failure; Stem Cell; Stroma vascular fraction; AFA

Outcome Measures

Primary Outcomes (2)

• Change NYHA functional class assessed with SAQ-7 -questionnaire

  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 ]

  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 Outcomes (2)

• Change NYHA functional class assessed with SAQ-7 -questionnaire

  12 months

• Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ]

  12 months

Study Arms (3)

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),

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

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),; Procedure: Infiltrtion of SVf

Interventions

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

Patient use 2 capsules 3 time a day by oral.

conventional therapy plus AFA; conventional therapy plus SVF and AFA

Infiltrtion of SVf PROCEDURE

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; conventional therapy plus SVF and AFA

Eligibility Criteria

• Age: 35 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

15 patients age from 35 to 80 yers old

You may qualify if:

• EF \< 45 %
• NYHA 2 - 3

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sociedad Española de Medicina Regenerativa y Terapia Celular: lead
• Clinica Castello 68: collaborator

Study Sites (1)

Clinca Castello 68

Madrid, 28001, Spain

RECRUITING

Related Publications (6)

• Sheu JJ, Lee MS, Wallace CG, Chen KH, Sung PH, Chua S, Lee FY, Chung SY, Chen YL, Li YC, Yip HK. Therapeutic effects of adipose derived fresh stromal vascular fraction-containing stem cells versus cultured adipose derived mesenchymal stem cells on rescuing heart function in rat after acute myocardial infarction. Am J Transl Res. 2019 Jan 15;11(1):67-86. eCollection 2019.

  PMID: 30787970 BACKGROUND

• Premaratne GU, Ma LP, Fujita M, Lin X, Bollano E, Fu M. Stromal vascular fraction transplantation as an alternative therapy for ischemic heart failure: anti-inflammatory role. J Cardiothorac Surg. 2011 Mar 31;6:43. doi: 10.1186/1749-8090-6-43.

  PMID: 21453457 BACKGROUND

• Kelm NQ, Beare JE, Yuan F, George M, Shofner CM, Keller BB, Hoying JB, LeBlanc AJ. Adipose-derived cells improve left ventricular diastolic function and increase microvascular perfusion in advanced age. PLoS One. 2018 Aug 24;13(8):e0202934. doi: 10.1371/journal.pone.0202934. eCollection 2018.

  PMID: 30142193 BACKGROUND

• Leblanc AJ, Nguyen QT, Touroo JS, Aird AL, Chang RC, Ng CK, Hoying JB, Williams SK. Adipose-derived cell construct stabilizes heart function and increases microvascular perfusion in an established infarct. Stem Cells Transl Med. 2013 Nov;2(11):896-905. doi: 10.5966/sctm.2013-0046. Epub 2013 Oct 8.

  PMID: 24106337 BACKGROUND

• Jensen GS, Hart AN, Zaske LA, Drapeau C, Gupta N, Schaeffer DJ, Cruickshank JA. Mobilization of human CD34+ CD133+ and CD34+ CD133(-) stem cells in vivo by consumption of an extract from Aphanizomenon flos-aquae--related to modulation of CXCR4 expression by an L-selectin ligand? Cardiovasc Revasc Med. 2007 Jul-Sep;8(3):189-202. doi: 10.1016/j.carrev.2007.03.004.

  PMID: 17765649 BACKGROUND

• Hart AN, Zaske LA, Patterson KM, Drapeau C, Jensen GS. Natural killer cell activation and modulation of chemokine receptor profile in vitro by an extract from the cyanophyta Aphanizomenon flos-aquae. J Med Food. 2007 Sep;10(3):435-41. doi: 10.1089/jmf.2007.401.

  PMID: 17887936 BACKGROUND

MeSH Terms

Conditions

Heart Failure

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Miguel G Garber, MD

  Healthy Longevity Clinic

  PRINCIPAL INVESTIGATOR

• Christian Drapeau, PhD

  Kalyagen

  STUDY DIRECTOR

Central Study Contacts

Miguel G Garber, MD

CONTACT

34 628766753; mggarber@gmail.com

Felix Pedrero, MD

CONTACT

34 622411766; consulta@doctorpedrero.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2020
• First Posted: August 17, 2020
• Study Start: May 20, 2021
• Primary Completion: December 15, 2022
• Study Completion: September 30, 2023
• Last Updated: January 3, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: 15 months to 3 years
• Access Criteria: Undecided

Locations

ES (1)