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

Peripheral Artery Disease Clinical Trial

Official title:

Phase I Study of Intramuscular (IM) Injection 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. These Placental Adherent Stromal Cells (ASCs) Are Expanded in the Company's Proprietary PluriXTM 3D Bioreactor System. PLX Cells Are Immune Privileged and Possess Immunomodulatory Properties.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00919958
• Other study ID #: PLX-PAD 1202-1
• Status: Completed
• Phase: Phase 1
• First received: June 10, 2009
• Last updated: June 17, 2012
• Start date: June 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: Pluristem Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Paul-Ehrlich-Institut
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 81 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Factorial Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Critical Limb Ischemia
• Ischemia
• Peripheral Arterial Disease
• Peripheral Artery Disease
• Peripheral Vascular Disease
• Peripheral Vascular Diseases
• Vascular Diseases

Intervention

Biological:
• PLX-PAD IM injection
Single treatment; multiple injections

Locations

Country	Name	City	State
Germany	Franziskus-Krankenhaus	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Pluristem Ltd.

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adverse events, Safety laboratory values and ECG findings		3 months	Yes
Primary	Immunological reaction		1 month	Yes
Secondary	Tumorigenesis		24 months	No