Ignite Creation Date:
2024-05-05 @ 11:54 PM
Last Modification Date:
2024-10-26 @ 10:41 AM
Study NCT ID:
NCT01449032
Status:
COMPLETED
Last Update Posted:
2014-06-10
First Post:
2011-10-06
Brief Title:
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia MyStromalCell Trial
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
MesenchYmal STROMAL CELL Therapy in Patients With Chronic Myocardial Ischemia MyStromalCell Trial
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MyStromalCell
Brief Summary:
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 patients symptoms
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 patients symptoms
Detailed Description:
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 patients symptoms
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 patients symptoms
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None