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

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

doi:10.1155/2017/8506370

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

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

Department of Clinical Medicine

15 Citations (Scopus)

61 Downloads (Pure)

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.

Original language	English
Article number	8506370
Journal	Stem Cells International
Volume	2017
Number of pages	8
ISSN	1687-966X
DOIs	https://doi.org/10.1155/2017/8506370
Publication status	Published - 2017

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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, 2017, [8506370]. https://doi.org/10.1155/2017/8506370

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. / Kastrup, Jens; Schou, Morten; Gustafsson, Ida et al.

In: Stem Cells International, Vol. 2017, 8506370, 2017.

Research output: Contribution to journal › Journal article › Research › peer-review

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 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, vol. 2017, 8506370. https://doi.org/10.1155/2017/8506370

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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",

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.",

author = "Jens Kastrup and Morten Schou and Ida Gustafsson and Nielsen, {Olav W} and Rasmus M{\o}gelvang and Kofoed, {Klaus F} and Charlotte Kragelund and Hove, {Jens Dahlgaard} and Andreas Fabricius-Bjerre and Merete Heitman and Mandana Haack-S{\o}rensen and Lund, {Lisbeth Drozd} and Johansen, {Ellen M{\o}nsted} and Qayyum, {Abbas Ali} and Mathiasen, {Anders Bruun} and Annette Ekblond",

year = "2017",

doi = "10.1155/2017/8506370",

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TY - JOUR

T1 - 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

T2 - A Phase II Danish Multicentre Study

AU - Kastrup, Jens

AU - Schou, Morten

AU - Gustafsson, Ida

AU - Nielsen, Olav W

AU - Møgelvang, Rasmus

AU - Kofoed, Klaus F

AU - Kragelund, Charlotte

AU - Hove, Jens Dahlgaard

AU - Fabricius-Bjerre, Andreas

AU - Heitman, Merete

AU - Haack-Sørensen, Mandana

AU - Lund, Lisbeth Drozd

AU - Johansen, Ellen Mønsted

AU - Qayyum, Abbas Ali

AU - Mathiasen, Anders Bruun

AU - Ekblond, Annette

PY - 2017

Y1 - 2017

N2 - 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.

AB - 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.

U2 - 10.1155/2017/8506370

DO - 10.1155/2017/8506370

M3 - Journal article

C2 - 29056973

SN - 1687-966X

VL - 2017

JO - Stem Cells International

JF - Stem Cells International

M1 - 8506370

ER -