Trial | NCT01351610  Report issue

Title

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

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    25
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
2011
Primary Completion
Oct 31
2014
Study Completion
Oct 31
2015
Last Update
Dec 15
2015
Estimate

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

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,
No Results Posted