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
  • Phase

    Phase 1/Phase 2
  • Study Type

  • Status

    Completed No Results Posted
  • Study Participants

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
Study Started
Mar 31
Primary Completion
Oct 31
Study Completion
Oct 31
Last Update
Dec 15

Biological PTA + Infusion of MSC_Apceth

percutaneous transluminal angioplasty followed by infusion of MSC_Apceth

Procedure PTA

percutaneous transluminal angioplasty only

Group B Experimental

  • Procedure PTA

Group A Experimental


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,
No Results Posted