Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting
Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells...
Ausführliche Beschreibung
Gespeichert in:
| Autor*in: |
Can, Alp [verfasserIn] Ulus, Ahmet Tulga [verfasserIn] Cinar, Ozgur [verfasserIn] Topal Celikkan, Ferda [verfasserIn] Simsek, Erdal [verfasserIn] Akyol, Mesut [verfasserIn] Canpolat, Ugur [verfasserIn] Erturk, Murat [verfasserIn] Kara, Fadil [verfasserIn] Ilhan, Osman [verfasserIn] |
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| Format: |
E-Artikel |
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| Sprache: |
Englisch |
| Erschienen: |
2015 |
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| Schlagwörter: |
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| Übergeordnetes Werk: |
Enthalten in: Stem cell reviews - New York, NY : Springer, 2005, 11(2015), 5 vom: 28. Juni, Seite 752-760 |
|---|---|
| Übergeordnetes Werk: |
volume:11 ; year:2015 ; number:5 ; day:28 ; month:06 ; pages:752-760 |
| Links: |
|---|
| DOI / URN: |
10.1007/s12015-015-9601-0 |
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| Katalog-ID: |
SPR023689374 |
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| 520 | |a Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. | ||
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| 650 | 4 | |a Regenerative medicine |7 (dpeaa)DE-He213 | |
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| 700 | 1 | |a Simsek, Erdal |e verfasserin |4 aut | |
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| 700 | 1 | |a Erturk, Murat |e verfasserin |4 aut | |
| 700 | 1 | |a Kara, Fadil |e verfasserin |4 aut | |
| 700 | 1 | |a Ilhan, Osman |e verfasserin |4 aut | |
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10.1007/s12015-015-9601-0 doi (DE-627)SPR023689374 (SPR)s12015-015-9601-0-e DE-627 ger DE-627 rakwb eng 570 610 ASE 42.15 bkl Can, Alp verfasserin aut Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. Umbilical cord MSC (dpeaa)DE-He213 Bone marrow MNC (dpeaa)DE-He213 Ischemic cardiomyopathy (dpeaa)DE-He213 Regenerative medicine (dpeaa)DE-He213 Stem cell therapy (dpeaa)DE-He213 Clinical trial (dpeaa)DE-He213 Ulus, Ahmet Tulga verfasserin aut Cinar, Ozgur verfasserin aut Topal Celikkan, Ferda verfasserin aut Simsek, Erdal verfasserin aut Akyol, Mesut verfasserin aut Canpolat, Ugur verfasserin aut Erturk, Murat verfasserin aut Kara, Fadil verfasserin aut Ilhan, Osman verfasserin aut Enthalten in Stem cell reviews New York, NY : Springer, 2005 11(2015), 5 vom: 28. Juni, Seite 752-760 (DE-627)494833777 (DE-600)2197218-7 1558-6804 nnns volume:11 year:2015 number:5 day:28 month:06 pages:752-760 https://dx.doi.org/10.1007/s12015-015-9601-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 42.15 ASE AR 11 2015 5 28 06 752-760 |
| spelling |
10.1007/s12015-015-9601-0 doi (DE-627)SPR023689374 (SPR)s12015-015-9601-0-e DE-627 ger DE-627 rakwb eng 570 610 ASE 42.15 bkl Can, Alp verfasserin aut Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. Umbilical cord MSC (dpeaa)DE-He213 Bone marrow MNC (dpeaa)DE-He213 Ischemic cardiomyopathy (dpeaa)DE-He213 Regenerative medicine (dpeaa)DE-He213 Stem cell therapy (dpeaa)DE-He213 Clinical trial (dpeaa)DE-He213 Ulus, Ahmet Tulga verfasserin aut Cinar, Ozgur verfasserin aut Topal Celikkan, Ferda verfasserin aut Simsek, Erdal verfasserin aut Akyol, Mesut verfasserin aut Canpolat, Ugur verfasserin aut Erturk, Murat verfasserin aut Kara, Fadil verfasserin aut Ilhan, Osman verfasserin aut Enthalten in Stem cell reviews New York, NY : Springer, 2005 11(2015), 5 vom: 28. Juni, Seite 752-760 (DE-627)494833777 (DE-600)2197218-7 1558-6804 nnns volume:11 year:2015 number:5 day:28 month:06 pages:752-760 https://dx.doi.org/10.1007/s12015-015-9601-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 42.15 ASE AR 11 2015 5 28 06 752-760 |
| allfields_unstemmed |
10.1007/s12015-015-9601-0 doi (DE-627)SPR023689374 (SPR)s12015-015-9601-0-e DE-627 ger DE-627 rakwb eng 570 610 ASE 42.15 bkl Can, Alp verfasserin aut Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. Umbilical cord MSC (dpeaa)DE-He213 Bone marrow MNC (dpeaa)DE-He213 Ischemic cardiomyopathy (dpeaa)DE-He213 Regenerative medicine (dpeaa)DE-He213 Stem cell therapy (dpeaa)DE-He213 Clinical trial (dpeaa)DE-He213 Ulus, Ahmet Tulga verfasserin aut Cinar, Ozgur verfasserin aut Topal Celikkan, Ferda verfasserin aut Simsek, Erdal verfasserin aut Akyol, Mesut verfasserin aut Canpolat, Ugur verfasserin aut Erturk, Murat verfasserin aut Kara, Fadil verfasserin aut Ilhan, Osman verfasserin aut Enthalten in Stem cell reviews New York, NY : Springer, 2005 11(2015), 5 vom: 28. Juni, Seite 752-760 (DE-627)494833777 (DE-600)2197218-7 1558-6804 nnns volume:11 year:2015 number:5 day:28 month:06 pages:752-760 https://dx.doi.org/10.1007/s12015-015-9601-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 42.15 ASE AR 11 2015 5 28 06 752-760 |
| allfieldsGer |
10.1007/s12015-015-9601-0 doi (DE-627)SPR023689374 (SPR)s12015-015-9601-0-e DE-627 ger DE-627 rakwb eng 570 610 ASE 42.15 bkl Can, Alp verfasserin aut Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. Umbilical cord MSC (dpeaa)DE-He213 Bone marrow MNC (dpeaa)DE-He213 Ischemic cardiomyopathy (dpeaa)DE-He213 Regenerative medicine (dpeaa)DE-He213 Stem cell therapy (dpeaa)DE-He213 Clinical trial (dpeaa)DE-He213 Ulus, Ahmet Tulga verfasserin aut Cinar, Ozgur verfasserin aut Topal Celikkan, Ferda verfasserin aut Simsek, Erdal verfasserin aut Akyol, Mesut verfasserin aut Canpolat, Ugur verfasserin aut Erturk, Murat verfasserin aut Kara, Fadil verfasserin aut Ilhan, Osman verfasserin aut Enthalten in Stem cell reviews New York, NY : Springer, 2005 11(2015), 5 vom: 28. Juni, Seite 752-760 (DE-627)494833777 (DE-600)2197218-7 1558-6804 nnns volume:11 year:2015 number:5 day:28 month:06 pages:752-760 https://dx.doi.org/10.1007/s12015-015-9601-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 42.15 ASE AR 11 2015 5 28 06 752-760 |
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10.1007/s12015-015-9601-0 doi (DE-627)SPR023689374 (SPR)s12015-015-9601-0-e DE-627 ger DE-627 rakwb eng 570 610 ASE 42.15 bkl Can, Alp verfasserin aut Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting 2015 Text txt rdacontent Computermedien c rdamedia Online-Ressource cr rdacarrier Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. Umbilical cord MSC (dpeaa)DE-He213 Bone marrow MNC (dpeaa)DE-He213 Ischemic cardiomyopathy (dpeaa)DE-He213 Regenerative medicine (dpeaa)DE-He213 Stem cell therapy (dpeaa)DE-He213 Clinical trial (dpeaa)DE-He213 Ulus, Ahmet Tulga verfasserin aut Cinar, Ozgur verfasserin aut Topal Celikkan, Ferda verfasserin aut Simsek, Erdal verfasserin aut Akyol, Mesut verfasserin aut Canpolat, Ugur verfasserin aut Erturk, Murat verfasserin aut Kara, Fadil verfasserin aut Ilhan, Osman verfasserin aut Enthalten in Stem cell reviews New York, NY : Springer, 2005 11(2015), 5 vom: 28. Juni, Seite 752-760 (DE-627)494833777 (DE-600)2197218-7 1558-6804 nnns volume:11 year:2015 number:5 day:28 month:06 pages:752-760 https://dx.doi.org/10.1007/s12015-015-9601-0 lizenzpflichtig Volltext GBV_USEFLAG_A SYSFLAG_A GBV_SPRINGER SSG-OLC-PHA GBV_ILN_20 GBV_ILN_22 GBV_ILN_23 GBV_ILN_24 GBV_ILN_31 GBV_ILN_32 GBV_ILN_39 GBV_ILN_40 GBV_ILN_60 GBV_ILN_62 GBV_ILN_65 GBV_ILN_69 GBV_ILN_70 GBV_ILN_73 GBV_ILN_74 GBV_ILN_90 GBV_ILN_95 GBV_ILN_100 GBV_ILN_105 GBV_ILN_120 GBV_ILN_138 GBV_ILN_152 GBV_ILN_161 GBV_ILN_171 GBV_ILN_187 GBV_ILN_224 GBV_ILN_250 GBV_ILN_281 GBV_ILN_285 GBV_ILN_293 GBV_ILN_370 GBV_ILN_602 GBV_ILN_702 GBV_ILN_2005 42.15 ASE AR 11 2015 5 28 06 752-760 |
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Enthalten in Stem cell reviews 11(2015), 5 vom: 28. Juni, Seite 752-760 volume:11 year:2015 number:5 day:28 month:06 pages:752-760 |
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Enthalten in Stem cell reviews 11(2015), 5 vom: 28. Juni, Seite 752-760 volume:11 year:2015 number:5 day:28 month:06 pages:752-760 |
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human umbilical cord mesenchymal stromal cell transplantation in myocardial ischemia (huc-heart trial). a study protocol of a phase 1/2, controlled and randomized trial in combination with coronary artery bypass grafting |
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Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting |
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Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. |
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Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. |
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Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. Baseline and post-transplantation outcome measures will be primarily utilized to test both the safety and the efficacy of the administered cells for up to 12 months. |
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<?xml version="1.0" encoding="UTF-8"?><collection xmlns="http://www.loc.gov/MARC21/slim"><record><leader>01000caa a22002652 4500</leader><controlfield tag="001">SPR023689374</controlfield><controlfield tag="003">DE-627</controlfield><controlfield tag="005">20230519163818.0</controlfield><controlfield tag="007">cr uuu---uuuuu</controlfield><controlfield tag="008">201006s2015 xx |||||o 00| ||eng c</controlfield><datafield tag="024" ind1="7" ind2=" "><subfield code="a">10.1007/s12015-015-9601-0</subfield><subfield code="2">doi</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(DE-627)SPR023689374</subfield></datafield><datafield tag="035" ind1=" " ind2=" "><subfield code="a">(SPR)s12015-015-9601-0-e</subfield></datafield><datafield tag="040" ind1=" " ind2=" "><subfield code="a">DE-627</subfield><subfield code="b">ger</subfield><subfield code="c">DE-627</subfield><subfield code="e">rakwb</subfield></datafield><datafield tag="041" ind1=" " ind2=" "><subfield code="a">eng</subfield></datafield><datafield tag="082" ind1="0" ind2="4"><subfield code="a">570</subfield><subfield code="a">610</subfield><subfield code="q">ASE</subfield></datafield><datafield tag="084" ind1=" " ind2=" "><subfield code="a">42.15</subfield><subfield code="2">bkl</subfield></datafield><datafield tag="100" ind1="1" ind2=" "><subfield code="a">Can, Alp</subfield><subfield code="e">verfasserin</subfield><subfield code="4">aut</subfield></datafield><datafield tag="245" ind1="1" ind2="0"><subfield code="a">Human Umbilical Cord Mesenchymal Stromal Cell Transplantation in Myocardial Ischemia (HUC-HEART Trial). A Study Protocol of a Phase 1/2, Controlled and Randomized Trial in Combination with Coronary Artery Bypass Grafting</subfield></datafield><datafield tag="264" ind1=" " ind2="1"><subfield code="c">2015</subfield></datafield><datafield tag="336" ind1=" " ind2=" "><subfield code="a">Text</subfield><subfield code="b">txt</subfield><subfield code="2">rdacontent</subfield></datafield><datafield tag="337" ind1=" " ind2=" "><subfield code="a">Computermedien</subfield><subfield code="b">c</subfield><subfield code="2">rdamedia</subfield></datafield><datafield tag="338" ind1=" " ind2=" "><subfield code="a">Online-Ressource</subfield><subfield code="b">cr</subfield><subfield code="2">rdacarrier</subfield></datafield><datafield tag="520" ind1=" " ind2=" "><subfield code="a">Abstract Mesenchymal stem cells (MSCs), which may be obtained from the bone marrow, have been studied for more than a decade in the setting of coronary artery disease (CAD). Adipose tissue-derived MSCs have recently come into focus and are being tested in a series of clinical trials. MSC-like cells have also been derived from a variety of sources, including umbilical cord stroma, or HUC-MSCs. The HUC-HEART trail (ClinicalTrials.gov Identifier: NCT02323477) is a phase 1/2, controlled, multicenter, randomized clinical study of the intramyocardial delivery of allogeneic HUC-MSCs in patients with chronic ischemic cardiomyopathy. A total of 79 patients (ages 30–80) with left ventricle ejection fractions ranging between 25 and 45 % will be randomized in a 2:1:1 pattern in order to receive an intramyocardial injection of either HUC-MSCs or autologous bone marrow-derived mononuclear cells (BM-MNCs) in combination with coronary arterial bypass grafting (CABG) surgery. The control group of patients will receive no cells and undergo CABG alone. Human HUC-MSCs will be isolated, propagated and banked in accordance with a cGMP protocol, whereas the autologous BM-MNCs will be isolated via aspiration from the iliac crest and subsequently process in a closed-circuit cell purification system shortly before cell transplantation. The cell injections will be implemented in 10 peri-infarct areas. 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