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

Pluri (Pluristem Therapeutics)

Status and phase: Completed; Phase 1

Conditions: Peripheral Vascular Disease; Peripheral Artery Disease; Critical Limb Ischemia

Treatments: Biological: PLX-PAD

Study type: Interventional

Funder types: Industry

Identifiers

NCT00951210

1202-2

Details and patient eligibility

About

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

Enrollment: 12 patients

Sex: All

Ages: 40 to 81 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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12 participants in 2 patient groups

PLX-PAD low dose

Experimental group

Description:

IM injection Single treatment; multiple injections

Treatment:

Biological: PLX-PAD

PLX-PAD high dose

Experimental group

Description:

IM injection Double treatment; multiple injections

Treatment:

Biological: PLX-PAD