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

Congestive Heart Failure Chronic Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04515537
• Other study ID #: 13245
• Status: Recruiting
• Start date: May 20, 2021
• Est. completion date: September 30, 2023

Study information

• Verified date: December 2022
• Source: Sociedad Española de Medicina Regenerativa y Terapia Celular
• Contact: Miguel G Garber, MD
• Phone: 34 628766753
• Email: mggarber[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 15
• Est. completion date: September 30, 2023
• Est. primary completion date: December 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Congestive Heart Failure Chronic
• Heart Failure

Intervention

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

Locations

Country	Name	City	State
Spain	Clinca Castello 68	Madrid

Sponsors (2)

Lead Sponsor	Collaborator
Sociedad Española de Medicina Regenerativa y Terapia Celular	Clinica Castello 68

Country where clinical trial is conducted

Spain, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Change NYHA functional class assessed with SAQ-7 -questionnaire	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
Secondary	Change of echocardiographic Parameters [ Time Frame: 0 and 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