Cyanophyta Aphanizomenon Flos-aquae, and Adipose Stroma Vascular Fraction, in Heart Failure Patient
NCT ID: NCT04515537
Last Updated: 2023-01-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
15 participants
OBSERVATIONAL
2021-05-20
2023-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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conventional therapy plus AFA
Patient using conventional therapy plus Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), for a period of 6 months
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
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
Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),
Patient use 2 capsules 3 time a day by oral.
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
Interventions
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Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA),
Patient use 2 capsules 3 time a day by oral.
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
Eligibility Criteria
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Inclusion Criteria
* NYHA 2 - 3
Exclusion Criteria
* 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.
35 Years
80 Years
ALL
No
Sponsors
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Clinica Castello 68
OTHER
Sociedad Española de Medicina Regenerativa y Terapia Celular
OTHER
Responsible Party
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Principal Investigators
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Miguel G Garber, MD
Role: PRINCIPAL_INVESTIGATOR
Healthy Longevity Clinic
Christian Drapeau, PhD
Role: STUDY_DIRECTOR
Kalyagen
Locations
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Clinca Castello 68
Madrid, , Spain
Countries
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Central Contacts
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Facility Contacts
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Felix Pedrero, MD
Role: backup
References
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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.
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.
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.
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.
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.
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.
Other Identifiers
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13245
Identifier Type: -
Identifier Source: org_study_id
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