Clinical trial NCT01351610: Tolerability and Efficacy of Intravenous Infusion of Autologous MSC_Apceth 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Critical Limb Ischemia
Peripheral Artery Disease
Keywords: Critical Limb Ischemia
Peripheral Arterial Occlusive Disease
Peripheral Artery Disease
Peripheral Vascular Disease
Stem Cell Therapy
Mesenchymal Stem Cells
Lead sponsor: Apceth GmbH & Co. KG
Sponsor class: INDUSTRY
First posted: 2011-05-11
Enrollment: 25
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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,

Primary outcomes:
measure: Collection of adverse events
timeFrame: one year
measure: Safety laboratory values
timeFrame: 1 year
measure: ECG findings
timeFrame: 1 year
measure: Analysis of inflammation markers
timeFrame: 1 year
Secondary outcomes:
measure: Comparison of course of haemodynamic and vascular processes
timeFrame: 1 year
Other outcomes:
Locations:
city: Munich
country: Germany
facility: Isar Medizin Zentrum
state: Bavaria
Study officials:
affiliation: Isar Medizin Zentrum, München
name: Peter Heider, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: