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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
Sponsored by
Pluristem Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

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:

  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.

Sites / Locations

  • Franziskus-Krankenhaus

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

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

First Posted
June 10, 2009
Last Updated
June 17, 2012
Sponsor
Pluristem Ltd.
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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
No
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

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