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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01351610
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : December 15, 2015
Information provided by (Responsible Party):
Apceth GmbH & Co. KG

May 10, 2011
May 11, 2011
December 15, 2015
March 2011
October 2014   (Final data collection date for primary outcome measure)
  • Collection of adverse events [ Time Frame: one year ]
  • Safety laboratory values [ Time Frame: 1 year ]
  • ECG findings [ Time Frame: 1 year ]
  • Analysis of inflammation markers [ Time Frame: 1 year ]
Evaluation safety and tolerability of the treatment with MSC-Apceth for Infusion and adverse events [ Time Frame: one year ]
Complete list of historical versions of study NCT01351610 on Archive Site
Comparison of course of haemodynamic and vascular processes [ Time Frame: 1 year ]
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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
MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia
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Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
  • Critical Limb Ischemia
  • Peripheral Artery Disease
  • Biological: PTA + Infusion of MSC_Apceth
    percutaneous transluminal angioplasty followed by infusion of MSC_Apceth
  • Procedure: PTA
    percutaneous transluminal angioplasty only
  • Experimental: Group B
    Intervention: Procedure: PTA
  • Experimental: Group A
    Intervention: Biological: PTA + Infusion of MSC_Apceth
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
October 2015
October 2014   (Final data collection date for primary outcome measure)

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,
Sexes Eligible for Study: All
40 Years to 80 Years   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
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Apceth GmbH & Co. KG
Apceth GmbH & Co. KG
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Principal Investigator: Peter Heider, MD, PhD Isar Medizin Zentrum, München
Apceth GmbH & Co. KG
December 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP