Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)

NCT ID: NCT00951210

Last Updated: 2015-05-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-08-31
• Study Completion Date: 2011-10-31

Brief Summary

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

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

IM injection Single treatment; multiple injections

Group Type: EXPERIMENTAL

PLX-PAD

Intervention Type: BIOLOGICAL

IM injection

PLX-PAD high dose

IM injection Double treatment; multiple injections

Group Type: EXPERIMENTAL

PLX-PAD

Intervention Type: BIOLOGICAL

IM injection

Interventions

PLX-PAD

IM injection

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 < 0.6 or/and TBI < 0.4

2. Rutherford category 4-5

3. Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.

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

5. Those diabetic subjects who are on optimal diabetes medication, with an HbA1c < 8%

Exclusion Criteria

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

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

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

4. 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)

5. 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

Locations

Cardiology PC

Birmingham, Alabama, United States

Duke University Medical Center

Durham, North Carolina, United States

Countries

United States

Other Identifiers

1202-2

Identifier Type: -

Identifier Source: org_study_id