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

Sponsor

Pluristem Ltd. (Industry)

Overall Status

Completed

CT.gov ID

NCT00951210

Collaborator

(none)

Enrollment

Locations

Arms

Duration (Months)

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Peripheral Artery Disease Peripheral Vascular Disease Critical Limb Ischemia	Biological: PLX-PAD	Phase 1

Study Design

Study Type:

Interventional

Actual Enrollment :

12 participants

Allocation:

Non-Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Phase I Study of Intramuscular (IM) Injections of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia. PLX-PAD Are Mesenchymal-Like Stromal Cells Derived From a Full Term Placenta.

Study Start Date :

Aug 1, 2009

Actual Primary Completion Date :

Jan 1, 2011

Actual Study Completion Date :

Oct 1, 2011

Arms and Interventions

Arm	Intervention/Treatment
Experimental: PLX-PAD low dose IM injection Single treatment; multiple injections	Biological: PLX-PAD IM injection
Experimental: PLX-PAD high dose IM injection Double treatment; multiple injections	Biological: PLX-PAD IM injection

Arm

Intervention/Treatment

Experimental: PLX-PAD low dose

IM injection Single treatment; multiple injections

Biological: PLX-PAD

IM injection

Experimental: PLX-PAD high dose

IM injection Double treatment; multiple injections

Biological: PLX-PAD

IM injection

Outcome Measures

Primary Outcome Measures

Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence [3 months]
Immunological reaction [3 months]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 81 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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
Rutherford category 4-5
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.
In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
Those diabetic subjects who are on optimal diabetes medication, with an HbA1c < 8%

Exclusion Criteria:

Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
Wounds with severity greater than Grade 2 on the Wagner Scale
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.
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)
In the opinion of the investigator, the patient is unsuitable for cellular therapy.