Randomized, double blind, placebo controlled trial of intramyocardial injection of autologous bone marrow cells in no-option patients with refractory angina pectoris and documented ischemia.

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON29227

Enrollment

Registered

2005-09-13

Start date

2005-05-01

Completion date

Unknown

Last updated

2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Refractory angina pectoris and documented myocardial ischemia.

Interventions

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 asp

Eligibility

Inclusion criteria

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

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 outcomes

Primary

Measure	Time frame
The change in myocardial perfusion (SPECT) at 3 monhts follow-up relative to baseline.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

—

Contacts

Public ContactJan Ramshorst, van

Leiden University Medical Center (LUMC) Department of Cardiology Postal zone: C5-P P.O. Box 9600

j.van_ramshorst@lumc.nl+31 (0)71 5262020

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)