Safety of Intramuscular Injection of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia

NCT ID: NCT00919958

Last Updated: 2012-06-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-06-30
• Study Completion Date: 2012-06-30

Brief Summary

The The purpose of this study is to determine the safety of PLX-PAD single dose, Intra-muscular injection for the treatment of CLI patients.

Detailed Description

PLX-PAD are mesenchymal-like stromal cells derived from a full term placenta, termed PLX-PAD, and intended for the treatment of Critical Limb Ischemia

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PLX-PAD low dose

Group Type: EXPERIMENTAL

PLX-PAD IM injection

Intervention Type: BIOLOGICAL

Single treatment; multiple injections

PLX-PAD intermediate dose

Group Type: EXPERIMENTAL

PLX-PAD IM injection

Intervention Type: BIOLOGICAL

Single treatment; multiple injections

PLX-PAD high dose

Group Type: EXPERIMENTAL

PLX-PAD IM injection

Intervention Type: BIOLOGICAL

Single treatment; multiple injections

Interventions

PLX-PAD IM injection

Single treatment; multiple injections

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

1. Diagnosis of critical limb ischemia defined as persistent, recurring ischemic rest pain for at least two (2) weeks, and/or ulceration or gangrene of the foot or toe, with ABI < 0.4 or/and TBI < 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot.

2. Rutherford category 4-5

3. No acceptable options for re-vascularisation as confirmed by angiographic imaging results or by color flow duplex ultrasound obtained within 6 months prior screening visit and signed approval of vascular surgeon.

4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.

Exclusion Criteria

1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).

2. Poorly controlled diabetes mellitus (HbA1c > 9%)

3. Wounds with severity greater than Grade 2 on the Wagner Scale

4. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina pectoris - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged

5. ST segment elevation myocardial infarction and/or TIA/CVA within six (6) months prior to enrollment. Patients with severe congestive heart failure (i.e. NYHA Stage IV)

6. In the opinion of the investigator, the patient is unsuitable for cellular therapy.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 81 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Pluristem Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Prof. Carsten Tschöpe, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Franziskus-Krankenhaus

Berlin, , Germany

Countries

Germany

Other Identifiers

PLX-PAD 1202-1

Identifier Type: -

Identifier Source: org_study_id