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

INTERVENTION: Product Name: MSC‐Apceth Product Code: NA Pharmaceutical Form: Suspension for injection INN or Proposed INN: human autologous CD34‐negative, bone‐marrow derived mesenchymal stem cells Other descriptive name: human autologous CD34‐negative, bone‐marrow derived mesenchymal stem cells Concentration unit: million organisms/ml million organisms/millilitre Concentration type: equal Concentration number: 5‐ CONDITION: Critical Limb Ischemia in Patients with Advanced Peripheral Arterial Occlusive Disease Subsequent to Percutaneous Transluminal Angioplasty ; MedDRA version: 14.1 Level: LLT Classification code 10066719 Term: Peripheral arterial occlusive disease aggravated System Organ Class: 100000004866 Therapeutic area: Diseases [C] ‐ Cardiovascular Diseases [C14] PRIMARY OUTCOME: Main Objective: 1. Evaluation of safety and tolerability of the treatment with MSC‐Apceth for Infusion subsequent to PTA by collecting the safety parameters and adverse events in both treatment groups (PTA plus MSC‐Apceth and PTA control group) during 12 months follow‐up;; ; Primary end point(s): 1. Evaluation safety and tolerability of the treatment with MSC‐Apceth for Infusion subsequent to PTA by collecting the safety parameters described below and adverse events in both treatment groups during 12 months follow‐up;; 2. Comparison of the clinical course of therapy by clinical parameters; ; 3. Comparison of the course of haemodynamic and vascular processes Secondary Objective: 2. Comparison of the clinical course of therapy by the clinical parameters (PTA plus MSC‐Apceth and PTA control group); ; ; 3. Comparison of the course of haemodynamic and vascular processes (PTA plus MSC‐Apceth and PTA control group); ; Timepoint(s) of evaluation of this end point: over the course of the clinical trial SECONDARY OUTCOME: Secondary end point(s): N/A Timepoint(s) of evaluation of this end point: N/A INCLUSION CRITERIA: 1. Adult male or female patients between 40 to 80 years of age at the time of screening visit, 2. 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, 3. Patients with staging of =III according to Fontaine and =4 according to Rutherford categories, 4. Patients fulfilling the criteria for an invasive re‐vascularisation procedure (PTA) at the discretion of the investigator, 5. Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator, 6. Inclusion is only possible for • Patients of group A with bone marrow donation, who completed the questionnaire for bone marrow donation without abnormal findings; • Patients with adequate organ and bone marrow function as defined by the followin