Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

Treatment of Advanced Gastrointestinal Cancer in a Phase I/II Trial With Modified Autologous MSC_apceth_101

To evaluate the safety and tolerability of MSC_apceth_101.

Inclusion Criteria:

• Patients with advanced or recurrent or metastatic gastrointestinal adenocarcinoma.
• Premature or scheduled termination of standard therapy
• Progressive disease as clinically assessed by the investigator
• Max. tumour lesion ≤ 5 cm
• Adequate organ function
• Ability of patient to understand character and individual consequences of clinical trial
• Age ≥ 18 years
• Written informed consent must be available before any study specific procedure is performed

Exclusion Criteria:

• Patients with severe heart diseases
• Clinical significant ischemic disease during the last 4 weeks before Visit 1
• Severe lung disease
• Symptomatic peritoneal carcinomatosis
• Symptomatic pleural or pericardial effusion
• Serious uncontrolled acute infections less than 3 weeks before Visit 1
• Known dependency on alcohol or other drugs
• Patients requiring corticoids in doses above the Cushing threshold
• Known liver fibrosis or liver cirrhosis
• Any concomitant severe disease which could compromise the objectives of this study in the judgment of the investigator
• Female patient who is pregnant or breast feeding
• Participation in another clinical trial or observation period, respectively, during the last 4 weeks prior to the first IMP dose