Condition category
Circulatory System
Date applied
23/11/2011
Date assigned
23/12/2011
Last edited
06/10/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

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

Trial website

Contact information

Type

Scientific

Primary contact

Dr R. Gökmen Turan

ORCID ID

Contact details

Medical Faculty of the University of Rostock
Patriostischer weg 24
Rostock
18057
Germany

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

2009/2

Study information

Scientific title

Intra-coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease: a non-randomised study

Acronym

Study hypothesis

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

Ethics Committee, University Rostock, Germany, 14/12/2008, ref: II PV 11/01

Study design

Non-randomized controlled study

Primary study design

Interventional

Secondary study design

Non randomised study

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

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

Phase

Drug names

Primary outcome measures

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 trial start date

01/02/2009

Overall trial end date

01/06/2010

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

24

Participant 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

Recruitment start date

01/02/2009

Recruitment end date

01/06/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Medical Faculty of the University of Rostock
Rostock
18057
Germany

Sponsor information

Organisation

University Hospital of Rostock (Universitätsklinikum Rostock) (Germany)

Sponsor details

Medical Faculty of the University of Rostock
Schillingallee 35
Rostock
18057
Germany

Sponsor type

University/education

Website

http://www.med.uni-rostock.de/

Funders

Funder type

University/education

Funder name

University Hospital of Rostock (Germany)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22534049

Publication citations

  1. Results

    Bozdag-Turan I, Turan RG, Ludovicy S, Akin I, Kische S, Schneider H, Rehders TC, Turan CH, Arsoy NS, Hermann T, Paranskaya L, Ortak J, Kohlschein P, Bastian M, Sahin K, Nienaber CA, Ince H, Intra coronary freshly isolated bone marrow cells transplantation improve cardiac function in patients with ischemic heart disease., BMC Res Notes, 2012, 5, 195, doi: 10.1186/1756-0500-5-195.

Additional files

Editorial Notes

06/10/2016: Plain English summary added.