Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth for the Treatment of Critical Limb Ischemia

Inclusion Criteria: 1. Patients with peripheral arterial occlusive disease (symptomatic PAOD), diagnosis of CLI defined as persistent, recurring ischemic rest pain for at least 2 weeks, and/or ulceration or gangrene of the foot or toe, with an ABPI \</= 0.5, 2. Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories, 3. Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator, 4. Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator, Exclusion Criteria: 1. Patients with wounds of a severity of greater than grade 2 on the Wagner Scale, 2. Patients with life-threatening ventricular arrhythmia, 3. Patients with unstable angina pectoris, 4. Patients with severe congestive heart failure (i.e. NYHA Stage IV), 5. Patients with uncontrolled hypertension (defined as diastolic blood pressure \>110 mmHg or systolic blood pressure \>180 mmHg during screening), 6. Patients with an uncontrolled diabetes mellitus (HbA1c \> 9%), 7. Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment, 8. Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,