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

NCT ID: NCT01351610

Last Updated: 2015-12-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-03-31

Study Completion Date

2015-10-31

Brief Summary

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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

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Conditions

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Critical Limb Ischemia Peripheral Artery Disease

Keywords

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Critical Limb Ischemia Peripheral Arterial Occlusive Disease Peripheral Artery Disease Peripheral Vascular Disease Stem Cell Therapy Mesenchymal Stem Cells

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group B

Group Type EXPERIMENTAL

PTA

Intervention Type PROCEDURE

percutaneous transluminal angioplasty only

Group A

Group Type EXPERIMENTAL

PTA + Infusion of MSC_Apceth

Intervention Type BIOLOGICAL

percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth

Interventions

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PTA + Infusion of MSC_Apceth

percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth

Intervention Type BIOLOGICAL

PTA

percutaneous transluminal angioplasty only

Intervention Type PROCEDURE

Eligibility Criteria

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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,
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Apceth GmbH & Co. KG

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Heider, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Isar Medizin Zentrum, München

Locations

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Isar Medizin Zentrum

Munich, Bavaria, Germany

Site Status

Countries

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Germany

Other Identifiers

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MSC_Apceth_001

Identifier Type: -

Identifier Source: org_study_id