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

Pluri (Pluristem Therapeutics)

Status and phase: Completed; Phase 1

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

Treatments: Biological: PLX-PAD IM injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT00919958

PLX-PAD 1202-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 15 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 < 0.4 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

---

15 participants in 3 patient groups

PLX-PAD low dose

Experimental group

Treatment:

Biological: PLX-PAD IM injection

PLX-PAD intermediate dose

Experimental group

Treatment:

Biological: PLX-PAD IM injection

PLX-PAD high dose

Experimental group

Treatment:

Biological: PLX-PAD IM injection