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Coronary artery disease (CAD) is the most common cause of death and a major cause of hospital admissions for acute chest pain. In spite of improved treatments still many patients with CAD have daily attacks of severe chest pain and severely reduced life quality.
The investigators have established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with adipose derived stem cells to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
In an open single centre pilot study we have evaluated the safety and efficacy of MSC treatment to improve heart muscle perfusion in patients with chronic CAD. Patients treated with MSCs had significant increased exercise capacity, reduction in angina, angina attacks and medication and in life quality at 6 months follow-up. For all the parameters there was a tendency towards improved outcome with increasing number of cells. The treatment with MSCs was safe.
The investigators have now established a double-blind placebo-controlled trial in patients with CAD to test efficacy and safety of treatment with MSCs to improve perfusion in the heart muscle and exercise capacity, and reduce the patient's symptoms.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MSC | Active Comparator | Adipose derived stem cells |
|
| Saline | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MSC | Biological | No of cells after culture expansion |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| Exercise test | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Clinical evaluation | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jens Kastrup, MD Professor | Department of Cardiology, Rigshospitalet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rigshospitalet University Hospital Copenhagen | Copenhagen | 210 | Denmark |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31711513 | Derived | Qayyum AA, Mathiasen AB, Helqvist S, Jorgensen E, Haack-Sorensen M, Ekblond A, Kastrup J. Autologous adipose-derived stromal cell treatment for patients with refractory angina (MyStromalCell Trial): 3-years follow-up results. J Transl Med. 2019 Nov 12;17(1):360. doi: 10.1186/s12967-019-2110-1. | |
| 29333165 | Derived |
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| ID | Term |
|---|---|
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
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| Saline | Biological | 3 cc saline |
|
| Qayyum AA, Mathiasen AB, Mygind ND, Kuhl JT, Jorgensen E, Helqvist S, Elberg JJ, Kofoed KF, Vejlstrup NG, Fischer-Nielsen A, Haack-Sorensen M, Ekblond A, Kastrup J. Adipose-Derived Stromal Cells for Treatment of Patients with Chronic Ischemic Heart Disease (MyStromalCell Trial): A Randomized Placebo-Controlled Study. Stem Cells Int. 2017;2017:5237063. doi: 10.1155/2017/5237063. Epub 2017 Dec 3. |
| D017670 |
| Sodium Compounds |