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
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 cr...
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Wiley
2017-01-01
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| Series: | Stem Cells International |
| Online Access: | http://dx.doi.org/10.1155/2017/8506370 |
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| author | 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 |
| author_facet | 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 |
| author_sort | Jens Kastrup |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-559ab98e8a3141588fdfd159d1ac88e2 |
| institution | Kabale University |
| issn | 1687-966X 1687-9678 |
| language | English |
| publishDate | 2017-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Stem Cells International |
| spelling | doaj-art-559ab98e8a3141588fdfd159d1ac88e22025-02-03T06:11:02ZengWileyStem Cells International1687-966X1687-96782017-01-01201710.1155/2017/85063708506370Rationale 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 StudyJens Kastrup0Morten Schou1Ida Gustafsson2Olav W. Nielsen3Rasmus Møgelvang4Klaus F. Kofoed5Charlotte Kragelund6Jens Dahlgaard Hove7Andreas Fabricius-Bjerre8Merete Heitman9Mandana Haack-Sørensen10Lisbeth Drozd Lund11Ellen Mønsted Johansen12Abbas Ali Qayyum13Anders Bruun Mathiasen14Annette Ekblond15Department of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Herlev Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Herlev Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Hvidovre Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, Bispebjerg Hospital, University of Copenhagen, Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkDepartment of Cardiology, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkCardiology Stem Cell Centre, The Heart Centre, Rigshospitalet, University of Copenhagen, Copenhagen, DenmarkBackground. 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.http://dx.doi.org/10.1155/2017/8506370 |
| spellingShingle | 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 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 |
| title | 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 |
| title_full | 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 |
| title_fullStr | 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 |
| title_full_unstemmed | 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 |
| title_short | 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 |
| title_sort | 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 |
| url | http://dx.doi.org/10.1155/2017/8506370 |
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