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

Study Overview
=================
Brief Summary
-----------------
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia

Official Title
-----------------
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

Conditions
-----------------
Critical Limb Ischemia, Peripheral Artery Disease

Intervention / Treatment
-----------------
* Biological: PTA + Infusion of MSC_Apceth
* Procedure: PTA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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, Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories, Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator, Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator, Exclusion Criteria: Patients with wounds of a severity of greater than grade 2 on the Wagner Scale, Patients with life-threatening ventricular arrhythmia, Patients with unstable angina pectoris, Patients with severe congestive heart failure (i.e. NYHA Stage IV), Patients with uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg during screening), Patients with an uncontrolled diabetes mellitus (HbA1c > 9%), Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment, Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group B<br> | Procedure: PTA<br>* percutaneous transluminal angioplasty only<br>|
| Experimental: Group A<br> | Biological: PTA + Infusion of MSC_Apceth<br>* percutaneous transluminal angioplasty followed by infusion of MSC_Apceth<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Collection of adverse events |  | one year | 
| Safety laboratory values |  | 1 year | 
| ECG findings |  | 1 year | 
| Analysis of inflammation markers |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of course of haemodynamic and vascular processes |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Critical Limb Ischemia, Peripheral Arterial Occlusive Disease, Peripheral Artery Disease, Peripheral Vascular Disease, Stem Cell Therapy, Mesenchymal Stem Cells