Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Clinica Castello 68 | OTHER |
Not provided
Not provided
Not provided
Not provided
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
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| conventional therapy plus AFA | Patient using conventional therapy plus Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), for a period of 6 months |
| |
| 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 |
| |
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Water-soluble Extract of the Cyanophyta Aphanizomenon Flos-aquae (AFA), | Dietary Supplement | Patient use 2 capsules 3 time a day by oral. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
15 patients age from 35 to 80 yers old
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Miguel G Garber, MD | Contact | 34 628766753 | mggarber@gmail.com | |
| Felix Pedrero, MD | Contact | 34 622411766 | consulta@doctorpedrero.com |
| Name | Affiliation | Role |
|---|---|---|
| Miguel G Garber, MD | Healthy Longevity Clinic | Principal Investigator |
| Christian Drapeau, PhD | Kalyagen | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinca Castello 68 | Recruiting | Madrid | 28001 | Spain |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30787970 | Background | 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. | |
| 21453457 |
Not provided
Not provided
all collected IPD, all IPD that underlie results in a publication
15 months to 3 years
Undecided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Aug 11, 2024 | |
| Reset | Nov 1, 2024 |
Not provided
Not provided
Not provided
Not provided
| 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 |
|
| 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 |
| 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. |
| 30142193 | 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. |
| 24106337 | 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. |
| 17765649 | 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. |
| 17887936 | 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. |
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Aug 11, 2024 | Nov 1, 2024 |
| ID | Term |
|---|---|
| D006333 | Heart Failure |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided