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Kastrup J, Schou M, Gustafsson I, et al. Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study. Stem Cells Int. 2017;2017:8506370doi: 10.1155/2017/8506370.
Kastrup, J., Schou, M., Gustafsson, I., Nielsen, O. W., Møgelvang, R., Kofoed, K. F., Kragelund, C., Hove, J. D., Fabricius-Bjerre, A., Heitman, M., Haack-Sørensen, M., Lund, L. D., Johansen, E. M., Qayyum, A. A., Mathiasen, A. B., & Ekblond, A. (2017). Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study. Stem cells international, 20178506370. https://doi.org/10.1155/2017/8506370
Kastrup, Jens, et al. "Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study." Stem cells international vol. 2017 (2017): 8506370. doi: https://doi.org/10.1155/2017/8506370
Kastrup J, Schou M, Gustafsson I, Nielsen OW, Møgelvang R, Kofoed KF, Kragelund C, Hove JD, Fabricius-Bjerre A, Heitman M, Haack-Sørensen M, Lund LD, Johansen EM, Qayyum AA, Mathiasen AB, Ekblond A. Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study. Stem Cells Int. 2017;2017:8506370. doi: 10.1155/2017/8506370. Epub 2017 Sep 19. PMID: 29056973; PMCID: PMC5625749.
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Stem Cells Int. 2017;2017:8506370. doi: 10.1155/2017/8506370. Epub 2017 Sep 19.

Rationale and Design of the First Double-Blind, Placebo-Controlled Trial with Allogeneic Adipose Tissue-Derived Stromal Cell Therapy in Patients with Ischemic Heart Failure: A Phase II Danish Multicentre Study.

Stem cells international

Jens Kastrup, Morten Schou, Ida Gustafsson, Olav W Nielsen, Rasmus Møgelvang, Klaus F Kofoed, Charlotte Kragelund, Jens Dahlgaard Hove, Andreas Fabricius-Bjerre, Merete Heitman, Mandana Haack-Sørensen, Lisbeth Drozd Lund, Ellen Mønsted Johansen, Abbas Ali Qayyum, Anders Bruun Mathiasen, Annette Ekblond

Affiliations

  1. Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  2. Cardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  3. Department of Cardiology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
  4. Department of Radiology, Herlev Hospital, University of Copenhagen, Copenhagen, Denmark.
  5. Department of Cardiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
  6. Department of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.
  7. Department of Radiology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
  8. Department of Radiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, Denmark.
  9. Department of Radiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, Denmark.

PMID: 29056973 PMCID: PMC5625749 DOI: 10.1155/2017/8506370

Abstract

BACKGROUND: Ischemic heart failure (IHF) has a poor prognosis in spite of optimal therapy. We have established a new allogeneic Cardiology Stem Cell Centre adipose-derived stromal cell (CSCC_ASC) product from healthy donors. It is produced without animal products, in closed bioreactor systems and cryopreserved as an off-the-shelf product ready to use.

STUDY DESIGN: A multicentre, double-blind, placebo-controlled phase II study with direct intramyocardial injections of allogeneic CSCC_ASC in patients with chronic IHF. A total of 81 patients will be randomised at 2 : 1 to CSCC_ASC or placebo. There is no HLA tissue type matching needed between the patients and the donors.

METHODS: The treatment will be delivered by direct injections into the myocardium. The primary endpoint is change in the left ventricle endsystolic volume at 6-month follow-up. Secondary endpoints are safety and changes in left ventricle ejection fraction, myocardial mass, stroke volume, and cardiac output. Other secondary endpoints are change in clinical symptoms, 6-minute walking test, and the quality of life after 6 and 12 months.

CONCLUSION: The aim of the present study is to demonstrate safety and the regenerative efficacy of the allogeneic CSCC_ASC product from healthy donors in a double-blind, placebo-controlled, multicentre study in patients with IHF.

References

  1. Cell Commun Signal. 2011 May 14;9:12 - PubMed
  2. J Invasive Cardiol. 2006 Nov;18(11):552-6 - PubMed
  3. Scand J Clin Lab Invest. 2016;76(2):93-104 - PubMed
  4. J Am Coll Cardiol. 2017 Feb 7;69(5):526-537 - PubMed
  5. Stem Cells Transl Med. 2013 Jun;2(6):455-63 - PubMed
  6. Circulation. 1987 Jul;76(1):44-51 - PubMed
  7. J Am Coll Cardiol. 2000 Dec;36(7):2072-80 - PubMed
  8. J Transl Med. 2013 Sep 18;11:219 - PubMed
  9. Circ Res. 2011 Apr 1;108(7):792-6 - PubMed
  10. J Am Coll Cardiol. 2009 Dec 8;54(24):2277-86 - PubMed
  11. J Am Coll Cardiol. 2012 Jan 31;59(5):539-40 - PubMed
  12. Europace. 2007 Mar;9(3):167-71 - PubMed
  13. Cardiovasc Ther. 2010 Dec;28(6):380-5 - PubMed
  14. Eur Heart J. 2015 Jul 14;36(27):1744-53 - PubMed
  15. Scand Cardiovasc J. 2011 Jun;45(3):161-8 - PubMed
  16. Cardiovasc Revasc Med. 2011 Jan-Feb;12(1):29-34 - PubMed
  17. Scand Cardiovasc J. 2016 Oct - Dec;50(5-6):293-299 - PubMed
  18. Int J Mol Med. 2016 Jan;37(1):115-25 - PubMed
  19. J Am Coll Cardiol. 2014 Apr 1;63(12 ):1123-1133 - PubMed
  20. Regen Med. 2012 May;7(3):421-8 - PubMed
  21. Circ Res. 2015 Aug 28;117(6):576-84 - PubMed
  22. Trends Mol Med. 2012 Feb;18(2):128-34 - PubMed
  23. Blood. 2008 Feb 1;111(3):1327-33 - PubMed
  24. Stem Cells Dev. 2013 Apr 1;22(7):1086-96 - PubMed
  25. Arch Iran Med. 2007 Oct;10(4):467-73 - PubMed
  26. Stem Cells Transl Med. 2017 Nov;6(11):1963-1971 - PubMed
  27. Circ Res. 2015 Apr 10;116(8):1346-60 - PubMed
  28. Int J Cardiol. 2013 Dec 10;170(2):246-51 - PubMed
  29. PLoS One. 2013 Jun 19;8(6):e64669 - PubMed
  30. Cell Transplant. 2013;22(3):521-8 - PubMed
  31. Stem Cells Dev. 2012 Sep 20;21(14):2724-52 - PubMed
  32. Am J Cardiol. 2004 Jul 1;94(1):92-5 - PubMed
  33. JAMA. 2012 Dec 12;308(22):2369-79 - PubMed
  34. J Transl Med. 2016 Nov 16;14 (1):319 - PubMed
  35. J Am Heart Assoc. 2013 Sep 30;2(5):e000253 - PubMed

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