Clinical trial NCT04515537: Cyanophyta Aphanizomenon Flos-aquae, and Adipose Stroma Vascular Fraction, in Heart Failure Patient
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Congestive Heart Failure Chronic
Keywords: Heart Failure
Stem Cell
Stroma vascular fraction
AFA
Lead sponsor: Sociedad Española de Medicina Regenerativa y Terapia Celular
Sponsor class: OTHER
Collaborators: name: Clinica Castello 68
First posted: 2020-08-17
Enrollment: 15
Sex: ALL
Minimum age (years): 35
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 15 patients age from 35 to 80 yers old

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.

Eligibility 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.

Primary outcomes:
measure: Change NYHA functional class assessed with SAQ-7 -questionnaire
timeFrame: 6 month
measure: Change of echocardiographic Parameters [ Time Frame: 0 and 6 months ]
timeFrame: 6 months
Secondary outcomes:
measure: Change NYHA functional class assessed with SAQ-7 -questionnaire
timeFrame: 12 months
measure: Change of echocardiographic Parameters [ Time Frame: 0 and 12 months ]
timeFrame: 12 months
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Clinca Castello 68
Study officials:
affiliation: Healthy Longevity Clinic
name: Miguel G Garber, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kalyagen
name: Christian Drapeau, PhD
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.
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.
citation: 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.