Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
Mesenchymal stem cells from the bone marrow can be stimulated to differentiate into endothelial cells and participate in the development of new blood vessels in ischemic tissue.
The aim of the study is in a phase I/II safety and efficacy study to evaluate the clinical effect of autologous mesenchymal stem cell therapy in patients with severe chronic myocardial ischemia.
4o patients with reversible ischemia on a SPECT will be treated with direct intramyocardial injections of autologous isolated and expanded mesenchymal stem cells.Clinical and objective evaluations will be performed at baseline and during 12 months follow-up.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mesenchymal stromal cell | Active Comparator | Mesenchymal stromal cell |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| stem cell | Biological | mesenchymal stromal cell |
|
| Measure | Description | Time Frame |
|---|---|---|
| Improvement in myocardial perfusion measured by SPECT | 6 months after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Safety | 6 months after treatment | |
| Improvement in myocardial perfusion and function measured by PET and MR | 6 months after treatment | |
| Exercise time |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jens Kastrup, MD DMSc | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cardiovascular Lab. 2014, The Heart Centre, Rigshospitalet, Blegdamcvej 9 | Copenhagen | 2100 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24211066 | Derived | Mathiasen AB, Haack-Sorensen M, Jorgensen E, Kastrup J. Autotransplantation of mesenchymal stromal cells from bone-marrow to heart in patients with severe stable coronary artery disease and refractory angina--final 3-year follow-up. Int J Cardiol. 2013 Dec 10;170(2):246-51. doi: 10.1016/j.ijcard.2013.10.079. Epub 2013 Oct 28. |
Not provided
Not provided
| Type | Date | Date Unknown |
|---|---|---|
| Release | Nov 18, 2013 | |
| Reset | Jan 6, 2014 | |
| Release | Jun 7, 2014 | |
| Unrelease | Yes | |
| Release | Nov 4, 2014 | |
| Reset | Nov 20, 2014 | |
| Release | Dec 29, 2014 | |
| Reset | Jan 16, 2015 | |
| Release | Jul 20, 2015 | |
| Reset | Jul 27, 2015 | |
| Release | Feb 1, 2016 | |
| Reset | Feb 29, 2016 | |
| Release | Sep 30, 2016 | |
| Reset | Nov 21, 2016 | |
| Release | Apr 20, 2020 | |
| Reset | Apr 28, 2020 | |
| Release | May 25, 2020 | |
| Reset | Jun 9, 2020 | |
| Release | Oct 16, 2020 | |
| Reset | Nov 9, 2020 | |
| Release | Jul 12, 2021 | |
| Reset | Aug 3, 2021 |
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Nov 18, 2013 | Jan 6, 2014 | |||
| Jun 7, 2014 |
| ID | Term |
|---|---|
| D017202 | Myocardial Ischemia |
| D003327 | Coronary Disease |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 6 months after treatment |
| Clinical angina status | 6 months after treatment |
| Yes |
| Nov 4, 2014 | Nov 20, 2014 |
| Dec 29, 2014 | Jan 16, 2015 |
| Jul 20, 2015 | Jul 27, 2015 |
| Feb 1, 2016 | Feb 29, 2016 |
| Sep 30, 2016 | Nov 21, 2016 |
| Apr 20, 2020 | Apr 28, 2020 |
| May 25, 2020 | Jun 9, 2020 |
| Oct 16, 2020 | Nov 9, 2020 |
| Jul 12, 2021 | Aug 3, 2021 |