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

Open, Randomized, Mono-Centre, Two-Parallel Group Clinical Phase I/II Trial on the Evaluation of Tolerability and Efficacy of an Intravenous Infusion of Human Bone Marrow Derived Autologous, CD34-Negative Mesenchymal Stem Cells for the Treatment of Critical Limb Ischemia in Patients With Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells 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,