GVP - Patient care and life-long follow up of applications according to "Good Vigilance Practice"
At the RTC we have established a register for the long term follow up of heart patients who have been treated with stem cells. These data are used to ensure the safety of the application of stem cell products in the cardiovascular field (TherapyVvigilance).
In the register the data of all patients are recorded who have been treated with stem cells in our clinic in the frame of their therapy or in the frame of clinical trials. Also, the register contains data from a small control group of patients. All data are documented in a pseudonymous form.
In 2014 we have started the systematic analysis of long-term data for the establishment of a “Good Vigilance Practice” (GVP)-monitoring. Based on these data we aim to formulate suggestions for standardization and quality assurance which may then be used in discussion with the expert communities and authorities for the formulation of guidelines for stem cell therapy of cardiovascular diseases. In the very first place, however, these analyses are of prime importance for the safety of our patients and for the optimization of our therapies. They also will be used to meet the legal requirements for the vigilance.
The register is web based such that other centres may easily join it. In the future, the RTC will more focus on the field of vigilance and health care research and try to initiate a closer communication in this field with authorities, health insurances and other partners.
Guideline "Good Pharmacovigilance Practice"