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

Peripheral Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01351610
• Other study ID #: MSC_Apceth_001
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: May 10, 2011
• Last updated: December 14, 2015
• Start date: March 2011
• Est. completion date: October 2015

Study information

• Verified date: December 2015
• Source: Apceth GmbH & Co. KG
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial Summary

MSC_Apceth are GMP-manufactured, autologous ex-vivo expanded non-hemapoietic bone-marrow derived stem cells for the treatment of Critical Limb Ischemia

Recruitment information / eligibility

• Status: Completed
• Enrollment: 25
• Est. completion date: October 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 80 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Arterial Occlusive Diseases
• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease

Intervention

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

Procedure:
• PTA
percutaneous transluminal angioplasty only

Locations

Country	Name	City	State
Germany	Isar Medizin Zentrum	Munich	Bavaria

Sponsors (1)

Lead Sponsor	Collaborator
Apceth GmbH & Co. KG

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Collection of adverse events		one year	Yes
Primary	Safety laboratory values		1 year	Yes
Primary	ECG findings		1 year	Yes
Primary	Analysis of inflammation markers		1 year	Yes
Secondary	Comparison of course of haemodynamic and vascular processes		1 year	No