Study to Assess Safety and Efficacy of Treating Symptomatic, Ischemic, Chronic Congestive Heart Failure Patients with an LVEF of ≤40% with Fresh, Uncultured, Autologous, Adipose-derived Regenerative Cells Isolated from Lipoaspirate.

Summary

To investigate patients suffering from iHF and a LVEF of equal or less than 40% despite best medical treatment safety and efficacy of a single retrograde intra-cardiac venous (i.cv.) injection of UA-ADRCs isolated from lipoaspirate at the point of care, using the Transpose® RT / Matrase System (InGeneron, Houston, TX, USA) through an over-the- wire, small balloon catheter, advanced through the coronary si-nus and located within a coronary vein at the site of inter-est, versus patients on best medical treatment.

Timeline

Start

2024-11-18

Primary completion

2025-10-31

Completion

2025-12-31

Publications

• Background Anderson JL, Morrow DA. Acute Myocardial Infarction. N Engl J Med. 2017 May 25;376(21):2053-2064. doi: 10.1056/NEJMra1606915. No abstract available.
• Background Ma T, Sun J, Zhao Z, Lei W, Chen Y, Wang X, Yang J, Shen Z. A brief review: adipose-derived stem cells and their therapeutic potential in cardiovascular diseases. Stem Cell Res Ther. 2017 Jun 5;8(1):124. doi: 10.1186/s13287-017-0585-3.
• Background Yu H, Lu K, Zhu J, Wang J. Stem cell therapy for ischemic heart diseases. Br Med Bull. 2017 Jan 1;121(1):135-154. doi: 10.1093/bmb/ldw059.
• Background Alt E, Pinkernell K, Scharlau M, Coleman M, Fotuhi P, Nabzdyk C, Matthias N, Gehmert S, Song YH. Effect of freshly isolated autologous tissue resident stromal cells on cardiac function and perfusion following acute myocardial infarction. Int J Cardiol. 2010 Sep 24;144(1):26-35. doi: 10.1016/j.ijcard.2009.03.124. Epub 2009 May 13.
• Background van Dijk A, Naaijkens BA, Jurgens WJ, Nalliah K, Sairras S, van der Pijl RJ, Vo K, Vonk AB, van Rossum AC, Paulus WJ, van Milligen FJ, Niessen HW. Reduction of infarct size by intravenous injection of uncultured adipose derived stromal cells in a rat model is dependent on the time point of application. Stem Cell Res. 2011 Nov;7(3):219-29. doi: 10.1016/j.scr.2011.06.003. Epub 2011 Jun 25.
• Background Houtgraaf JH, den Dekker WK, van Dalen BM, Springeling T, de Jong R, van Geuns RJ, Geleijnse ML, Fernandez-Aviles F, Zijlsta F, Serruys PW, Duckers HJ. First experience in humans using adipose tissue-derived regenerative cells in the treatment of patients with ST-segment elevation myocardial infarction. J Am Coll Cardiol. 2012 Jan 31;59(5):539-40. doi: 10.1016/j.jacc.2011.09.065. No abstract available.
• Background Comella K, Parcero J, Bansal H, Perez J, Lopez J, Agrawal A, Ichim T. Effects of the intramyocardial implantation of stromal vascular fraction in patients with chronic ischemic cardiomyopathy. J Transl Med. 2016 Jun 2;14(1):158. doi: 10.1186/s12967-016-0918-5.
• Background Swijnenburg RJ, Tanaka M, Vogel H, Baker J, Kofidis T, Gunawan F, Lebl DR, Caffarelli AD, de Bruin JL, Fedoseyeva EV, Robbins RC. Embryonic stem cell immunogenicity increases upon differentiation after transplantation into ischemic myocardium. Circulation. 2005 Aug 30;112(9 Suppl):I166-72. doi: 10.1161/CIRCULATIONAHA.104.525824.
• Background Zhang Y, Wang D, Chen M, Yang B, Zhang F, Cao K. Intramyocardial transplantation of undifferentiated rat induced pluripotent stem cells causes tumorigenesis in the heart. PLoS One. 2011 Apr 28;6(4):e19012. doi: 10.1371/journal.pone.0019012.
• Background Trounson A. Potential Pitfall of Pluripotent Stem Cells. N Engl J Med. 2017 Aug 3;377(5):490-491. doi: 10.1056/NEJMcibr1706906. No abstract available.
• Background Fraser JK, Wulur I, Alfonso Z, Hedrick MH. Fat tissue: an underappreciated source of stem cells for biotechnology. Trends Biotechnol. 2006 Apr;24(4):150-4. doi: 10.1016/j.tibtech.2006.01.010. Epub 2006 Feb 20.
• Background Ong WK, Sugii S. Adipose-derived stem cells: fatty potentials for therapy. Int J Biochem Cell Biol. 2013 Jun;45(6):1083-6. doi: 10.1016/j.biocel.2013.02.013. Epub 2013 Mar 1.
• Background Klein SM, Vykoukal J, Li DP, Pan HL, Zeitler K, Alt E, Geis S, Felthaus O, Prantl L. Peripheral Motor and Sensory Nerve Conduction following Transplantation of Undifferentiated Autologous Adipose Tissue-Derived Stem Cells in a Biodegradable U.S. Food and Drug Administration-Approved Nerve Conduit. Plast Reconstr Surg. 2016 Jul;138(1):132-139. doi: 10.1097/PRS.0000000000002291.
• Background Jiang T, Xu G, Wang Q, Yang L, Zheng L, Zhao J, Zhang X. In vitro expansion impaired the stemness of early passage mesenchymal stem cells for treatment of cartilage defects. Cell Death Dis. 2017 Jun 1;8(6):e2851. doi: 10.1038/cddis.2017.215.
• 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.
• Background Nyberg E, Farris A, O'Sullivan A, Rodriguez R, Grayson W. Comparison of Stromal Vascular Fraction and Passaged Adipose-Derived Stromal/Stem Cells as Point-of-Care Agents for Bone Regeneration. Tissue Eng Part A. 2019 Nov;25(21-22):1459-1469. doi: 10.1089/ten.TEA.2018.0341. Epub 2019 Jun 14.
• Background Polly SS, Nichols AEC, Donnini E, Inman DJ, Scott TJ, Apple SM, Werre SR, Dahlgren LA. Adipose-Derived Stromal Vascular Fraction and Cultured Stromal Cells as Trophic Mediators for Tendon Healing. J Orthop Res. 2019 Jun;37(6):1429-1439. doi: 10.1002/jor.24307. Epub 2019 Apr 29.

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