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.