Mesenchymal stem cells after acute myocardial infarction.

Autologous bone marrow-derived in vitro expanded mesenchymal stem cell transplantation in patients with an acute myocardial infarction treated by successful primary percutaneous transluminal coronary angioplasty A safety and feasibility study

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON24674

Enrollment

Registered

2008-11-26

Start date

2006-01-01

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

Acute myocardial infarction

Interventions

- Bone marrow cell aspiration from the iliac crest - Ex-vivo expansion of mesenchymal stem cells - Intramyocardial injection (by catheterization) of expanded mesenchymal stem cells

Eligibility

Inclusion criteria

Inclusion criteria: 1. Acute ST segment elevation myocardial infarction treated by successful primary PTCA of the infarct related coronary artery within 12 hours after onset of chest pain 2. Increase in CPK levels >1600 U/L 3. Male or female >18 years old 4. Able and willing to undergo all the tests used in the protocol 5. Written informed consent

Exclusion criteria

Exclusion criteria: 1. Previous myocardial infarction or CABG 2. Evidence of cancer (except low grade and fully resolved non-melanoma skin malignancy) 3. Concurrent participation in a study using an experimental drug or an experimental procedure within 2 months before acute myocardial infarction 4. Unstable medical situation e.g. life-threatening heart failure 5. Other severe concurrent illnesses (e.g. active infection, aortic stenosis, renal failure) 6. Bleeding diathesis or HIV infection 7. 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 8. Candidates for additional surgical or percutaneous intervention within the study period

Design outcomes

Primary

Measure	Time frame
- Safety and feasibility of intramyocardial injection of ex vivo expanded mesenchymal stem cells after primary PTCA for acute myocardial infarction	—

Secondary

Measure	Time frame
- To assess the efficacy of autologous bone marrow-derived in vitro expanded mesenchymal stem cell transplantation after successful primary PTCA for acute myocardial infarction: - Infarct size assessed by gated SPECT (baseline vs. 3 months) - Left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume as assessed by gated SPECT (baseline vs. 3 months)	—

Measure

Time frame

- To assess the efficacy of autologous bone marrow-derived in vitro expanded mesenchymal stem cell transplantation after successful primary PTCA for acute myocardial infarction: - Infarct size assessed by gated SPECT (baseline vs. 3 months) - Left ventricular ejection fraction, left ventricular end-diastolic volume and left ventricular end-systolic volume as assessed by gated SPECT (baseline vs. 3 months)

—

Contacts

Public ContactD.E. Atsma

Leiden University Medical Center Department of Cardiology Postbus 9600

cardio@lumc.nl+31 (0)71 5262020

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)