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

Tracking Information

First Received Date ^ICMJE

May 10, 2011

Last Updated Date

January 30, 2012

Start Date ^ICMJE

March 2011

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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 ]

Original Primary Outcome Measures ^ICMJE

Evaluation safety and tolerability of the treatment with MSC-Apceth for Infusion and adverse events [ Time Frame: one year ] [ Designated as safety issue: Yes ]

Change History

Complete list of historical versions of study NCT01351610 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Not Provided

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Phase 1
Phase 2

Study Design ^ICMJE

Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment

Condition ^ICMJE

Critical Limb Ischemia
Peripheral Artery Disease

Intervention ^ICMJE

Biological: PTA + Infusion of MSC_Apceth
percutaneous transluminal angioplasty followed by infusion of MSC_Apceth
Procedure: PTA
percutaneous transluminal angioplasty only

Study Arm (s)

Experimental: Group B
Intervention: Procedure: PTA
Experimental: Group A
Intervention: Biological: PTA + Infusion of MSC_Apceth

Publications *

Not Provided

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Estimated Completion Date

March 2013

Estimated Primary Completion Date

March 2012 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

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,
Patients with staging of ≥III according to Fontaine and ≥4 according to Rutherford categories,
Patients fulfilling the criteria for an invasive re-vascularisation procedure (PTA) at the discretion of the investigator,
Patients without major amputation of the lower extremities within the period of 6 months after inclusion in the opinion of the investigator,

Exclusion Criteria:

Patients with wounds of a severity of greater than grade 2 on the Wagner Scale,
Patients with life-threatening ventricular arrhythmia,
Patients with unstable angina pectoris,
Patients with severe congestive heart failure (i.e. NYHA Stage IV),
Patients with uncontrolled hypertension (defined as diastolic blood pressure >110 mmHg or systolic blood pressure >180 mmHg during screening),
Patients with an uncontrolled diabetes mellitus (HbA1c > 9%),
Patients having any history of malignant tumour in the anamnesis or are currently on tumour treatment,
Patients who are unsuitable for a MSC stem cell therapy in the opinion of the investigator,

Gender

Both

Ages

40 Years to 80 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact: Peter Heider, MD, PhD

0049891499037200

dr.heider@gefaesschirurgie-muenchen.net

Location Countries ^ICMJE

Germany

Administrative Information

NCT Number ^ICMJE

NCT01351610

Other Study ID Numbers ^ICMJE

MSC_Apceth_001

Has Data Monitoring Committee

Yes

Responsible Party

Apceth GmbH & Co. KG

Study Sponsor ^ICMJE

Apceth GmbH & Co. KG

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Principal Investigator:

Peter Heider, MD, PhD

Isar Medizin Zentrum, München

Information Provided By

Apceth GmbH & Co. KG

Verification Date

January 2012

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

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