Intramyocardial Application of Stem Cells in combination with transmyocardial Laser Revascularisation (TMLR) in CABG Patients - INSTEM-Trial

Conditions: Other forms of chronic ischaemic heart disease
MedDRA version: 70Level: LLTClassification code 10032058

Registration Number: EUCTR2005-004051-35-DE

Lead Sponsor: niversity Hospital Düsseldorf

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- over 18 years
- presence of at least two vessel coronary artery disease with at least one vessel
that is not amenable to CABG surgery and serves an area of viable myocardium
- signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- any condition that prevents succesful stem cell collection
- predominant existence of nonviable myocardium
- no informed consent
-pervious heart surgery within the last six months

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Evaluation of Safety;Secondary Objective: - Major advers cardiac event<br>- Improvement Quality of Life (Seattle Angina Questionaire)<br>- Reduction of classes in the modified CCS grading scale<br>- Improvement Exercise Tolerance (Bruce protocol);Primary end point(s): -Evaluation of safety

Secondary Outcome Measures