Clinical Trials Unit

Download Summary

Research for life

Many mechanisms contributing to the evolution of blood cancer have not yet been investigated, and the surveillance of cancer cells by the immune system, in particular, is only partly understood. There is a lack of disease stage-specific studies for many types of blood cancer whose results could be incorporated into essential treatment decisions and serve as medical guidelines for physicians. The optimization of established therapies also makes a decisive contribution to improve a patient’s chance of survival. Fundamental research and scientific cooperation on an international and interdisciplinary level are of crucial importance here.

Interdisciplinary network with expertise

For this reason, DKMS founded the CTU in 2013 as a scientific unit with the goal of designing, initiating and carrying out landmark studies in the field of blood cancer and stem cell transplantation. The CTU is a highly professional and experienced interdisciplinary team located in Dresden, Germany. Two other DKMS organizations, the DKMS Life Science Lab and the DKMS Stem Cell Bank, are also based there. In Dresden, we also have close contacts with local academic research networks. The CTU works together with national and international transplant centers and scientists on trendsetting research projects.

Active improvement of the situation for both patients and donors

Blood cancer research

The CTU enables development and advances in areas of research which may not attract the attention of the pharmaceutical industry, and for which invested resources are therefore limited. Thus, we close a crucial gap in the field of blood cancer research.

Our CTU aims to initiate and support clinical research in the field of blood cancer treatment. The main focus of research is allogeneic blood stem cell transplantation. The CTU initiates and conducts clinical trials to find the most effective therapies for patients, and to improve the success rate of stem cell transplantations.

Organizational and editorial responsibility for clinical trials

Clinical studies in the field of stem cell therapy – with bone marrow or peripheral blood stem cells – are subject to specific legal and regulatory requirements.

Our CTU develops the scientific background for these studies and submits the necessary applications to the authorities and ethics committees. Furthermore, we take responsibility for the organization and proper conduct of those studies.

Together with our partners, we ensure responsibility for the study participants’ safety and the scientific validity of trial results. Finally, our scientists analyze and interpret the data together with the scientific community and publish the results at conferences and in renowned journals. Based on the results, new treatment guidelines may benefit future patients.

Research Studies involving DKMS donors

As part of our commitment to scientific research, our CTU team also supports clinical and non-clinical projects which require donor blood or donor stem cells. Many of these studies aim at developing new strategies to prevent or treat post-transplant complications (e.g., graft versus host disease, virus infections and relapse).

We ensure regulatory compliance regarding ethical approval in Germany, including translation/drafting of the donor informed consent in German.

Academic research groups that require blood or stem cells from DKMS Germany donors can request this at workup level. To do so, please submit the following documents to externalstudy@dkms.de:

• Protocol/Project Description
• Ethics Committee/IRB Approval
• Donor Information and Donor Consent Form
• Completed Access Application Form

If the project is positively evaluated, a Material Transfer Agreement can be concluded. Afterwards, we will prepare the donor information and consent form according to German guidelines and inform our Workup department that material requests for your research project can be supported. The collection center will be informed accordingly.

We offer this service at no cost for the applicant.

Immunogenetic research

The immune system plays a crucial role in the treatment and cure of cancer, especially when it comes to stem cell transplantation from related or unrelated donors. Immunogenetic donor characteristics, for example, play a decisive role in the selection of donors. Biologists, physicians, computer scientists and mathematicians at CTU work together with renowned scientists worldwide to better understand the immune system’s role in cancer. Large-scale international studies led by us are based on the understanding of biological processes, methodological know-how, valuable cooperation and the passion and commitment from everyone in the team. The aim is to generate scientific knowledge and translate this into more second chances at life.

Biobank activities

A further focus of the CTU is the expansion and coordination of the Collaborative Biobank (CoBi), a cooperative science platform that provides resources for research projects in the field of blood cancer worldwide.

“We want to save lives – as often as possible!”

Prof. Dr. med. Johannes Schetelig, M.Sc. – Head of Clinical Trials Unit

Our Team

The CTU team includes physicians, biologists, computer scientists, mathematicians and statisticians, lawyers and psychologists. This makes us a strong partner in the national and international research landscape. Our team has many years of experience coordinating and conducting clinical trials and performing immunogenetic research.