This site became the new on June 19th. Learn more.
Show more Menu IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu IMPORTANT: Talk with a trusted healthcare professional before volunteering for a study. Read more... Menu
Give us feedback

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

This study has been completed.
Information provided by (Responsible Party):
Apceth GmbH & Co. KG Identifier:
First received: May 10, 2011
Last updated: December 14, 2015
Last verified: December 2015
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
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

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

Primary Outcome Measures:
  • 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 ]

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

Enrollment: 25
Study Start Date: March 2011
Study Completion Date: October 2015
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


Ages Eligible for Study:   40 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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 identifier: NCT01351610

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

Responsible Party: Apceth GmbH & Co. KG Identifier: NCT01351610     History of Changes
Other Study ID Numbers: MSC_Apceth_001
Study First Received: May 10, 2011
Last Updated: December 14, 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:
Peripheral Arterial Disease
Arterial Occlusive Diseases
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases
Peripheral Vascular Diseases processed this record on August 23, 2017