Intra-coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease
| ISRCTN | ISRCTN54510226 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN54510226 |
| Secondary identifying numbers | 2009/2 |
- Submission date
- 23/11/2011
- Registration date
- 23/12/2011
- Last edited
- 06/10/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Circulatory System
Plain English summary of protocol
Background and study aims:
Ischemic heart disease occurs when the heart's blood supply is blocked or interrupted by a build-up of fatty substances in the coronary arteries. The main symptoms are chest pain, heart attacks and heart failure. Cell therapy is a promising new treatment option. The aim of this study is to find out whether transplantation of a patient’s bone marrow stem cells into their heart has beneficial effects on their heart function.
Who can participate?
Patients aged 18 - 80 who have had a heart attack in the last 3 months
What does the study involve?
There are two groups of patients in this study. Both groups undergo coronary angiography, a test that uses dye and x rays to show the insides of the coronary arteries. One group receives cell therapy, while the other group does not receive cell therapy. Heart function is assessed at the start and 6 months later.
What are the possible benefits and risks of participating?
Not provided at time of registration
Where is the study run from?
University Hospital of Rostock (Germany)
When is the study starting and how long is it expected to run for?
February 2009 to June 2010
Who is funding the study?
University Hospital of Rostock (Germany)
Who is the main contact?
Dr R Gökmen Turan
Contact information
Scientific
Medical Faculty of the University of Rostock
Patriostischer weg 24
Rostock
18057
Germany
Study information
| Study design | Non-randomized controlled study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Intra-coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease: a non-randomised study |
| Study objectives | In this study we analyzed whether intracoronary autologous freshly isolated bone marrow cells transplantation (BMCs-Tx) have beneficial effects on cardiac function in patients with ischemic heart disease (IHD) |
| Ethics approval(s) | Ethics Committee, University Rostock, Germany, 14/12/2008, ref: II PV 11/01 |
| Health condition(s) or problem(s) studied | Ischemic heart disease |
| Intervention | There are two groups, both groups underwent coronary angiography, first group received additional cell therapy, second group serve as control group received only coronary angiography without cell therapy. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | The change in global ejection fraction (EF) as well as the size of infarcted area measured baseline and 6 months after coronary angiography in both groups. |
| Secondary outcome measures | The functional status by New York Heart Association (NYHA) classification and Brain natriuretic peptide (BNP) level in peripheral blood measured baseline and 6 months after coronary angiography in both groups. |
| Overall study start date | 01/02/2009 |
| Completion date | 01/06/2010 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Upper age limit | 80 Years |
| Sex | Both |
| Target number of participants | 24 |
| Key inclusion criteria | 1. Patients between 18-80 years of age 2. Had a documented myocardial infarction (MI) at least 3 months 3. Had a clear-cut demarcated region of the left ventricular dysfunction with and open infarct related coronary artery |
| Key exclusion criteria | 1. Presence of acutely decompensated heart failure with NYHA class of IV 2. Infectious or inflammatory disease 3. Active bleeding 4. Surgery or trauma within 2 months 5. Renal or liver dysfunction 6. Tthrombocytopenia or anemia 7. Alcohol or drug dependency 8. A history of other severe chronic diseases or cancer 9. Unwillingness to participate |
| Date of first enrolment | 01/02/2009 |
| Date of final enrolment | 01/06/2010 |
Locations
Countries of recruitment
- Germany
Study participating centre
18057
Germany
Sponsor information
University/education
Medical Faculty of the University of Rostock
Schillingallee 35
Rostock
18057
Germany
| Website | http://www.med.uni-rostock.de/ |
|---|---|
"ROR" |
https://ror.org/04dm1cm79 |
Funders
Funder type
University/education
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 25/04/2012 | Yes | No |
Editorial Notes
06/10/2016: Plain English summary added.
