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

Phase 1

Completed

• Conditions: Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia
• Interventions: Biological: PLX-PAD IM injection

• Registration Number: NCT00919958
• Lead Sponsor: Pluristem Ltd.

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

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-10
• Study First Submitted QC: 2009-06-11
• Study First Posted: 2009-06-12
• Status Verified: 2012-06
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Last Update Submitted: 2012-06-17
• Last Update Posted: 2012-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
PLX-PAD low dose	PLX-PAD IM injection	-
PLX-PAD intermediate dose	PLX-PAD IM injection	-
PLX-PAD high dose	PLX-PAD IM injection	-

Primary Outcome Measures

Name	Time	Method
Adverse events, Safety laboratory values and ECG findings	3 months
Immunological reaction	1 month

Secondary Outcome Measures

Name	Time	Method
Tumorigenesis	24 months

Trial Locations

Locations (1)

Franziskus-Krankenhaus; 🇩🇪 Berlin, Germany