Back to results

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

Primary Purpose

Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Status

Completed

Phase

Phase 1

Locations

Germany

Study Type

Interventional

Intervention

PLX-PAD IM injection

About this trial

This is an interventional treatment trial for Peripheral Artery Disease focused on measuring Peripheral Artery Disease, Peripheral Vascular Disease, Critical limb ischemia

Eligibility Criteria

40 Years - 81 Years (Adult, Older Adult)All SexesDoes not accept 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 < 0.4 or/and TBI < 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot.
Rutherford category 4-5
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.
In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.

Exclusion Criteria:

Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
Poorly controlled diabetes mellitus (HbA1c > 9%)
Wounds with severity greater than Grade 2 on the Wagner Scale
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
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.

Sites / Locations

Franziskus-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Arm Label

PLX-PAD low dose

PLX-PAD intermediate dose

PLX-PAD high dose

Arm Description

Outcomes

Primary Outcome Measures

Adverse events, Safety laboratory values and ECG findings

Immunological reaction

Secondary Outcome Measures

Tumorigenesis

Full Information

NCT ID

NCT00919958

First Posted

June 10, 2009

Last Updated

June 17, 2012

Sponsor

Pluristem Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT00919958

Brief Title

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

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.

Study Type

Interventional

2. Study Status

Record Verification Date

June 2012

Overall Recruitment Status

Completed

Study Start Date

June 2009 (undefined)

Primary Completion Date

June 2012 (Actual)

Study Completion Date

June 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Pluristem Ltd.

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Peripheral Artery Disease, Peripheral Vascular Disease, Critical Limb Ischemia

Keywords

Peripheral Artery Disease, Peripheral Vascular Disease, Critical limb ischemia

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Factorial Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

15 (Actual)

8. Arms, Groups, and Interventions

Arm Title

PLX-PAD low dose

Arm Type

Experimental

Arm Title

PLX-PAD intermediate dose

Arm Type

Experimental

Arm Title

PLX-PAD high dose

Arm Type

Experimental

Intervention Type

Biological

Intervention Name(s)

PLX-PAD IM injection

Intervention Description

Single treatment; multiple injections

Primary Outcome Measure Information:

Title

Adverse events, Safety laboratory values and ECG findings

Time Frame

3 months

Title

Immunological reaction

Time Frame

1 month

Secondary Outcome Measure Information:

Title

Tumorigenesis

Time Frame

24 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Maximum Age & Unit of Time

81 Years

Accepts Healthy Volunteers

Eligibility Criteria

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 < 0.4 or/and TBI < 0.4 or transcutaneous partial pressure of oxygen ≤ 30 mmHg pO2 at the foot. Rutherford category 4-5 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. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months. Exclusion Criteria: Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening). Poorly controlled diabetes mellitus (HbA1c > 9%) Wounds with severity greater than Grade 2 on the Wagner Scale 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 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Prof. Carsten Tschöpe, MD

Organizational Affiliation

Charite University, Berlin, Germany

Official's Role

Principal Investigator

Facility Information:

Facility Name

Franziskus-Krankenhaus

City

Berlin

Country

Germany

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs