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

This study is currently recruiting participants.
Verified January 2012 by Apceth GmbH & Co. KG
Sponsor:
Information provided by (Responsible Party):
Apceth GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01351610
First received: May 10, 2011
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia


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

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Apceth GmbH & Co. KG:

Primary Outcome Measures:
  • Collection of adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]
  • Safety laboratory values [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • ECG findings [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
  • Analysis of inflammation markers [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Comparison of course of haemodynamic and vascular processes [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: March 2011
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   40 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01351610

Contacts
Contact: Peter Heider, MD, PhD 0049891499037200 dr.heider@gefaesschirurgie-muenchen.net

Locations
Germany
Isar Medizin Zentrum Recruiting
Munich, Bavaria, Germany, 80331
Contact: Peter Heider, MD, PhD            
Principal Investigator: Peter Heider, MD, PhD            
Sponsors and Collaborators
Apceth GmbH & Co. KG
Investigators
Principal Investigator: Peter Heider, MD, PhD Isar Medizin Zentrum, München
  More Information

No publications provided

Responsible Party: Apceth GmbH & Co. KG
ClinicalTrials.gov Identifier: NCT01351610     History of Changes
Other Study ID Numbers: MSC_Apceth_001
Study First Received: May 10, 2011
Last Updated: January 30, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

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:
Arterial Occlusive Diseases
Ischemia
Peripheral Arterial Disease
Vascular Diseases
Cardiovascular Diseases
 Pathologic Processes
Atherosclerosis
Arteriosclerosis
Peripheral Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013