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

Phase 1

Completed

• Conditions: Critical Limb Ischemia; Peripheral Artery Disease
• Interventions: Procedure: PTA; Biological: PTA + Infusion of MSC_Apceth

• Registration Number: NCT01351610
• Lead Sponsor: Apceth GmbH & Co. KG

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 available

Study Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-10
• Study First Posted: 2011-05-11
• Primary Completion: 2014-10
• Study Completion: 2015-10
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-14
• Last Update Posted: 2015-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 25

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,

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group B	PTA	-
Group A	PTA + Infusion of MSC_Apceth	-

Primary Outcome Measures

Name	Time	Method
Collection of adverse events	one year
Safety laboratory values	1 year
Analysis of inflammation markers	1 year
ECG findings	1 year

Secondary Outcome Measures

Name	Time	Method
Comparison of course of haemodynamic and vascular processes	1 year

Trial Locations

Locations (1)

Isar Medizin Zentrum; 🇩🇪 Munich, Bavaria, Germany