The aim of this study is determining whether repeat intramyocardial injection of bone marrow cells is safe and effective in the treatment of refractionary angina pectoris.
ID
Bron
Verkorte titel
Aandoening
refractory angina pectoris
bone marrow cell
intramyocardial injection
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
The change in myocardial perfusion at 3 months follow-up relative to baseline.
Achtergrond van het onderzoek
N/A
Doel van het onderzoek
The aim of this study is determining whether repeat intramyocardial injection of bone marrow cells is safe and effective in the treatment of refractionary angina pectoris.
Onderzoeksopzet
At 3 and 6 months follow-up.
Onderzoeksproduct en/of interventie
1. After written informed consent has been obtained, quality of life and exercise capacity will be investigated. Myocardial perfusion and function will be documented;
2. Bone marrow will be aspired from the iliac crest under local or general anesthesia;
3. In all patients NOGA mapping will be performed with subsequent intramyocardial injection of autologous bone marrow-derived mononuclear cells;
4. Quality of life, ccs class and exercise capacity will be reassessed at 3 and 6 monhts follow-up. In addition, changes in myocardial function perfusion and function will be evaluated at 3 months follow-up.
Publiek
Department of Cardiology<br>
Postbus 9600
D.E. Atsma
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
cardio@lumc.nl
Wetenschappelijk
Department of Cardiology<br>
Postbus 9600
D.E. Atsma
Albinusdreef 2
Leiden 2300 RC
The Netherlands
+31 (0)71 5262020
cardio@lumc.nl
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
1. Having received intramyocardial bone marrow cell injection in study P02.051 (Injection of Autologous Bone Marrow Cells into Damaged Myocardium of No-option Patients with Refractory Angina Pectoris and Ischemia, a two-phased study of safety, feasibility and efficacy) or P05.025 (Efficacy assessment of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia, a randomized, double blind, placebo controlled study);
2. Disabling refractory angina pectoris despite optimal medical therapy;
3. Residual reversible ischemia on GATED-SPECT imaging;
4. No candidate for (repeat) revascularization;
5. Male or female, > 18 years old;
6. Patients must be stable and not be in a setting of life-threatening heart failure (LVEF>35%);
7. Able to perform an exercise tolerance test prior to therapy;
8. Able and willing to undergo all the tests used in this protocol including the traveling involved;
9. Written informed consent.
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
1. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) as bone marrow cell infusion might promote tumor growth through induction of angiogenesis in the tumor;
2. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before the injection procedure;
3. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure);
4. Bleeding diathesis or HIV infection;
5. Any other condition that, in the opinion of the investigator, could pose a significant threat to the subject if the investigational therapy was to be initiated;
6. Inability to undergo cardiac catheterization or nuclear testing;
7. Inability to follow the protocol and comply with follow-up requirements;
8. Candidates for surgical of percutaneous intervention;
9. Mechanical aortic valve prosthesis.
Opzet
Deelname
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Geen registraties gevonden.
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL2546 |
| NTR-old | NTR2664 |
| CCMO | NL30970.000.10 |
| ISRCTN | ISRCTN wordt niet meer aangevraagd. |