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Table 1 Objectives and endpoints of the TREAT-ME1 study

From: Treatment of advanced gastrointestinal tumors with genetically modified autologous mesenchymal stromal cells (TREAT-ME1): study protocol of a phase I/II clinical trial

Objective Endpoint
Primary Safety and tolerability of MSC_apceth_101 (phase I and II)
Key secondary • Total and individual size of relapse/metastases by CT or MRT according to RECIST criteria (phase I/II, group 1)
• Detection of the therapeutic transgene expressed by homing MSC in resected tumor specimen by PCR technique shortly after its administration (phase II, group 2)
• For comparison: Detection of the therapeutic transgene expressed by homing MSC in normal tissue adjacent to the tumor (phase II, group 2)
• Optionally: PET activity in initially PET positive patients (phase I/II, group 1)
•Tumor/serum markers (phase I/II, both patient groups)
Other secondary •Time to progression up to 1 year after first MSC_apceth_101 administration (phase I/II)
• Overall survival up to 1 year after first MSC_apceth_101 administration (phase I/II)