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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.
ClinicalTrials.gov Identifier:
NCT00919958
First received: June 10, 2009
Last updated: June 17, 2012
Last verified: June 2012
History of Changes
  Purpose

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.


Condition Intervention Phase
Peripheral Artery Disease
Peripheral Vascular Disease
Critical Limb Ischemia
 Biological: PLX-PAD IM injection
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Factorial Assignment
Masking: Open Label
Primary Purpose: Treatment
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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Pluristem Ltd.:

Primary Outcome Measures:
  • Adverse events, Safety laboratory values and ECG findings [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Immunological reaction [ Time Frame: 1 month ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Tumorigenesis [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Enrollment: 15
Study Start Date: June 2009
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLX-PAD low dose Biological: PLX-PAD IM injection
Single treatment; multiple injections
Experimental: PLX-PAD intermediate dose Biological: PLX-PAD IM injection
Single treatment; multiple injections
Experimental: PLX-PAD high dose Biological: PLX-PAD IM injection
Single treatment; multiple injections

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

  Eligibility

Ages Eligible for Study:   40 Years to 81 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00919958

Locations
Germany
Franziskus-Krankenhaus
Berlin, Germany
Sponsors and Collaborators
Pluristem Ltd.
Investigators
Principal Investigator: Prof. Carsten Tschöpe, MD Charité , Berlin
  More Information

No publications provided

Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT00919958     History of Changes
Other Study ID Numbers: PLX-PAD 1202-1
Study First Received: June 10, 2009
Last Updated: June 17, 2012
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Pluristem Ltd.:
Peripheral Artery Disease
Peripheral Vascular Disease
Critical limb ischemia

Additional relevant MeSH terms:
Ischemia
Vascular Diseases
Peripheral Vascular Diseases
Peripheral Arterial Disease
Pathologic Processes
 Cardiovascular Diseases
Atherosclerosis
Arteriosclerosis
Arterial Occlusive Diseases

ClinicalTrials.gov processed this record on May 16, 2013