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

This study has been terminated.
(The primary outcome of this open clinical trial "Safety & Tolerability of MSC-Apceth" was achieved with the minimum number of patients needed.)
Sponsor:
Information provided by (Responsible Party):
Apceth GmbH & Co. KG
ClinicalTrials.gov Identifier:
NCT01351610
First received: May 10, 2011
Last updated: November 5, 2014
Last verified: November 2014
  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:


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: December 2014
Primary Completion Date: October 2014 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01351610

Locations
Germany
Isar Medizin Zentrum
Munich, Bavaria, Germany, 80331
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: November 5, 2014
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
Arteriosclerosis
Atherosclerosis
Cardiovascular Diseases
Pathologic Processes
Peripheral Vascular Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on November 19, 2014