Other forms of chronic ischaemic heart disease MedDRA version: 70 Level: LLT Classification code 10032058
Conditions
Interventions
Product Name: autologous stem cells
Product Code: CD 133*
Pharmaceutical Form: Injection*
Sponsors
University Hospital Düsseldorf
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation of Safety;Secondary Objective: - Major advers cardiac event - Improvement Quality of Life (Seattle Angina Questionaire) - Reduction of classes in the modified CCS grading scale - Improvement Exercise Tolerance (Bruce protocol);Primary end point(s): -Evaluation of safety | — |
Countries
Germany
Outcome results
None listed