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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.
 
ClinicalTrials.gov Identifier: NCT01351610
Recruitment Status : Completed
First Posted : May 11, 2011
Last Update Posted : December 15, 2015
Sponsor:
Information provided by (Responsible Party):
Apceth GmbH & Co. KG

Study Description
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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

Condition or disease Intervention/treatment Phase
Critical Limb Ischemia Peripheral Artery Disease Biological: PTA + Infusion of MSC_Apceth Procedure: PTA Phase 1 Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : March 2011
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2015

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Group B Procedure: PTA
percutaneous transluminal angioplasty only
Experimental: Group A Biological: PTA + Infusion of MSC_Apceth
percutaneous transluminal angioplasty followed by infusion of MSC_Apceth


Outcome Measures
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Primary Outcome Measures :
  1. Collection of adverse events [ Time Frame: one year ]
  2. Safety laboratory values [ Time Frame: 1 year ]
  3. ECG findings [ Time Frame: 1 year ]
  4. Analysis of inflammation markers [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. Comparison of course of haemodynamic and vascular processes [ Time Frame: 1 year ]

Eligibility Criteria
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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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,
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01351610


Locations
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Germany
Isar Medizin Zentrum
Munich, Bavaria, Germany, 80331
Sponsors and Collaborators
Apceth GmbH & Co. KG
Investigators
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Principal Investigator: Peter Heider, MD, PhD Isar Medizin Zentrum, München
More Information
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Responsible Party: Apceth GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01351610    
Other Study ID Numbers: MSC_Apceth_001
First Posted: May 11, 2011    Key Record Dates
Last Update Posted: December 15, 2015
Last Verified: December 2015
Keywords provided by Apceth GmbH & Co. KG:
Critical Limb Ischemia
Peripheral Arterial Occlusive Disease
Peripheral Artery Disease
 Peripheral Vascular Disease
Stem Cell Therapy
Mesenchymal Stem Cells
Additional relevant MeSH terms:
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Peripheral Arterial Disease
Chronic Limb-Threatening Ischemia
Arterial Occlusive Diseases
Ischemia
Pathologic Processes
Atherosclerosis
 Arteriosclerosis
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases
Chronic Disease
Disease Attributes