No registrations found.
ID
Source
Health condition
bone marrow cells, stem cell therapy, refractory angina, intramyocardial injection
Sponsors and support
Intervention
Outcome measures
Primary outcome
The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.
Secondary outcome
EFFICACY:
Clinical end points:
1. Angina frequency;
2. Canadian cardiovascular society score;
3. Quality of life;
4. Exercise capacity.
Functional end points:
5. Change in LV ejection fraction at 3 monhts follow-up;
6. Regional myocardial function on a segmental base at 3 monhts follow-up.
Safety:
7. Occurence of ahrrythmias;
8. Pericardial effusion > 5 mm (echo);
9. Myocardial damage;
10. Severe inflammation.
Background summary
After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial function and perfusion will be documented.
Bone marrow will be aspired from the iliac crest under local anesthesia.
In patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells.
Quality of life and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
Study objective
The aim of this study is to provide more insight in the therapeutic effect and mechanism of action of intramyocardial bone marrow cell injection in patients with refractionary angina pectoris and documented ischemia.
Study design
At 3 and 6 months follow-up.
Intervention
After written informed consent has been obtained, quality of life and exercise capacity will be investigated. In addition myocardial function and perfusion will be documented.
Bone marrow will be aspired from the iliac crest under local anesthesia.
In patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells.
Quality of life and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function and perfusion will be evaluated at 3 months follow-up.
Department of Cardiology<br>
Postbus 9600
D.E. Atsma
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
cardio@lumc.nl
Department of Cardiology<br>
Postbus 9600
D.E. Atsma
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
cardio@lumc.nl
Inclusion criteria
1. Severe refractory angina despite optimal medical therapy;
2. Reversible ischemia on GATED-SPECT;
3. No candidate for (repeat) revascularization (CABG or PCI);
4. Male or female, > 18 years old;
5. Patients must be stable (e.g. not be in a setting of life-threatening heart failure);
6. Written informed consent.
Exclusion criteria
1. Acute myocardial infarction, PCI or CABG within 6 months of enrolment in the study;
2. History of malignancy (except low grade and fully resolved non-melanoma skin malignancy);
3. Unexplained haematological or biochemical abnormalities;
4. Concurrent participation in a study using an experimental drug or an experimental procedure within 6 months before the injection procedure;
5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure);
6. Bleeding diathesis or HIV infection;
7. Inability to follow the protocol and comply with follow-up requirements.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL2821 |
| NTR-old | NTR2962 |
| Other | MEC LUMC : P05.025 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |