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      1. TRACE
      2. For Patients and Donors

      For Patients and Donors

      Treatment of chemo-refractory viral infections after allogeneic stem cell transplantation with virus-specific T cells:

      A phase III, prospective, multi-national clinical trial

      TRACE is the first multi-national clinical trial to prove efficacy and safety of Adoptive T-cell transfer in immunocompromised individuals. Until now, 181 out of 246 (74%) patients with various viral diseases have been successfully treated with virus-specific T cells. TRACE will provide data, ethical and regulatory approvals and logistic infrastructure to build the basis for bringing adoptive transfer of virus-specific T cells into clinical routine.

      • From Bench To Bedside

        Clinical trials are necessary to obtain or expand our knowledge about the efficacy and tolerability of medicinal products. Therefore, the legislature has stipulated that new medicinal products must be clinically tested. As required by law, the TRACE trial has been approved by the responsible authority and has been issued a favourable opinion by independent ethics committees.

        TRACE ("TRansfer of Adenovirus, Cytomegalovirus and Epstein-Barr virus-specific T cells") is 

        - Phase III

        - randomized Placebo-controlled and

        - Double-blind 

        The TRACE trial will be conducted in about 35 clinical centres of six European countries: Belgium, France, Germany, Italy, the Netherlands and UK. A total of approximately 150 children as well as adults are expected to participate. The study is coordinated by the Dr. von Hauner Children's Hospital (Sponsor) and funded by the European Commission.

      • The aim of the TRACE trial is the development of individualized medicine. T-cell immunity is one of the most individualized aspects of human physiology. Using adoptive transfer of mulitvirus-specific T cells will enable the patient to protect himself instead of receiving toxic antiviral chemotherapy. T-cell therapy is "help to help themselves".

        European patient health will benefit through a safe, curative and innovative individualized treatment option, that has not been available for the majority of eligible patients in the past. Further the project will contribute evidence-based data on this treatment:

        - reduced rate of CMV, EBV or AdV infections/reactivations

        - reduced frequency of hospitalizations

        - reduced medication intake

      • Hello!

        Hello! We are at the hospital. Can I tell you all about it? 

        You have to come to see a special doctor...

        You have to come to see a special doctor who is going to try to give you some medicine for your illness.

        Urheberschaft ungeklärt 

        New medicine 

        To give you the new medicine, the doctor will stick a needle in your arm one time you come to the hospital. It may hurt a little for a short time.

        You will have to come to the hosptial...

        You will have to come to the hospital with your family to see the study doctor a few times.

        Urheberschaft ungeklärt 

        The nice nurse will take some blood...

        The nice nurse will take some of your blood from your arm with a needle. This may hurt a little for a short time.

        The doctor asks your mummy and daddy some questions...

        Wait whilst the doctor asks your mummy or daddy some questions. The doctor will then write a bit in a big folder and his computer.

        Urheberschaft ungeklärt 

        Your parents will have to fill a paper about the new medicine...

        At two times your parents will have to fill a paper with questions about how you feel and what you think about the new medicine. They might need your help to answer the questions. Thank you for listening this with your family

        If you are not feeling well...

        If you are not feeling well, please tell your parents and they will call your doctor and ask him what to do.

        Questions? 

        If there is anything you did not understand, please ask! 

        Goodbye and see you soon!

      • Your immune response upon viral infection will be investigated within accompanying research. 

      Links

      • DRKS-ID der Studie: DRKS00018985
      • EudraCT Register: 2018-000853-29
      • ClinicalTrials: NCT04832607
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