TREAT-ME 1: Treatment of advanced gastrointestinal cancer in a clinical phase I/II trial with genetically modified mesenchymal stem cells: Clinical results of a phase I study.

e13535 Background: Treatment options based on genetically modified cells may add alternative therapeutic modalites to medical oncology. The investigational medicinal product is a genetically modified mesenchymal-stem-cell-suspension (gmMSC) for i.v. infusion. The integration of the therapeutic gene Herpes-Simplex-Thymidinkinase (HSV-TK) under the control of a tumor specific promoter is accomplished through the use of a SIN-gamma- vector system. Patients received gmMSC - infusion at days 1, 8, 15. Each followed by Ganciclovir (q2d) on day 3-5, 10-12, 17-19. Two dose levels of gmMSC were evaluated. Methods: Six Patients with relapsed gastrointestinal adenocarcinoma and liver and/or lung metastasis non-responsive to standard therapy were treated. No signs of active infection. Dose escalation (1.5 Mio.- to 3.0 Mio. MSC/kg BW) was determined by the German Competent Authority (PEI) after the completion of 3 patients. Patients´– safety/tolerability and technical feasibility of the MSC_acpeth_101 infusion were th...