this website provides you with information about the current possibilities to treat cardiovascular diseases with stem cells at the Clinic and Policlinic for Cardiac Surgery of Rostock. In addition, you will be able to find informaton about the state of the art on the field of cardiac stem cell therapy.
If you are treating patients with appropriate indication, please contact us, we will be happy to discuss these individual cases.
Lost of contractile myocardium – mostly as a consequence of myocardial infarction – generally causes an irreversible restriction of heart function due to its limited capacity of regeneration. A novel therapy approach involves the treatment with stem cells: Adult stem cells taken from the patient´s own bone marrow can foster the angiogenesis of the heart.
In Germany, studies testing treatments with stem cells after myocardial infarction exist since 2001. One of the first physicians worldwide to perform a bone-marrow-derived stem cell transplant to the myocardium during a bypass surgery was Prof. Gustav Steinhoff at the Clinic and Policlinic for Cardiac Surgery of Rostock. Hence, this technique could successfully pass through clinical Phase I and II studies. In the meantime it has been reviewed and approved by further centers. Due to the successful results the stem cell therapy is already accepted as an innovative treatment by some health insurance funds today. At the University Hospital Rostock already more than 200 patients suffering from myocardial infarction and heart insufficience were successfully treated with stem cells.
To participate in this program of therapy patients have to comply with the following requirements:
- Situation after myocardial infarction with indication to bypass surgery
- Reduced LVEF measured by Cardiac-MRT during resting state
- Define akinetic/ hypokinetic/ less perfused part of the heart
Clinical Phase III study
The RTC started a controlled, prospective, randomized, double-blind multicentric Phase III study in autumn 2009. We want to prove that the injection of autologous bone-marrow-derived stem cells after a myocardial infarction shows an additional positive effect as compared to bypass surgery without stem cell treatment. The Clinic and Policlinic for Cardiac Surgery of Rostock has initiated this study in which also the German Heart Institute Berlin, the Hannover Medical School, University Heart center Leipzig, University Heart center Hamburg and Heart and Diabetes Center North Rhine-Westphalia, Bad Oeynhausen are participating. Around 150 patients are needed for this study. If you’re considering a participation in this study, please contact us. We will inform you in details about inclusion and exclusion criteria as well as the process of study.
The study will be accompanied by additional resarch in order to get detailed information about the mechanism of effect and in order to prove the long-term safety of the therapy. More information is posted here. At the end of the Phase III study the cardiac stem cell therapy should be standardised to an extent so that it can be applied Europe-wide. We will offer seminars and trainings for users in the future.
Currently, there are different application techniques for cardiac stem cell therapy, i.e., intravascular and intramyocardial techniques:
Intravascular technique: Cells are injected either in a peripheral venous or intracoronar manner.
Intramyocardial technique: Cells are injected directly or with help of a catheter into the endocardium during a heart surgery
At Rostock the intramyocardial technique is be applied during a heart surgery, especially to patients with chronic ischemia after a myocardial infarction. Until now results exist from more than 200 patients who participated in clinical studies or who have been treated outside of these studies since 2001. Nearly all patients show improved perfusion of myocardium, in particular the microperfusion.
The Phase I/II and Phase II studies reveal the following results:
Phase I/II study: Significant long-term improvement of pump function of left heart chamber by 10%.
The ischemic areas which could not be bridged by a bypass showed a secondary improved perfusion after the stem cell therapy.
Phase II study: Significant improvement of heart function compared to a randomised control group by 10%. However this technique works effectively in particular for patients with reduced pump function of left heart chamber.