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

NCT01351610 | Completed Phase 1 DMC

• 1 other identifier: MSC_Apceth_001
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

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

Conditions

Critical Limb Ischemia; Peripheral Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (4)

• Collection of adverse events

  one year

• Safety laboratory values

  1 year

• ECG findings

  1 year

• Analysis of inflammation markers

  1 year

Secondary Outcomes (1)

• Comparison of course of haemodynamic and vascular processes

  1 year

Study Arms (2)

Group B

EXPERIMENTAL

Procedure: PTA

Group A

EXPERIMENTAL

Biological: PTA + Infusion of MSC_Apceth

Interventions

PTA + Infusion of MSC_Apceth BIOLOGICAL

percutaneous transluminal angioplasty followed by infusion of MSC\_Apceth

Group A

PTA PROCEDURE

percutaneous transluminal angioplasty only

Group B

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,

You may not qualify if:

• 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,

Sponsors & Collaborators

• Apceth GmbH & Co. KG: lead

Study Sites (1)

Isar Medizin Zentrum

Munich, Bavaria, 80331, Germany

Location

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Peripheral Arterial Disease; Peripheral Arterial Occlusive Disease 1; Peripheral Vascular Diseases

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Officials

• Peter Heider, MD, PhD

  Isar Medizin Zentrum, München

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 10, 2011
• First Posted: May 11, 2011
• Study Start: March 1, 2011
• Primary Completion: October 1, 2014
• Study Completion: October 1, 2015
• Last Updated: December 15, 2015

Record last verified: 2015-12

Locations

DE (1)