Safety of Intramuscular Injections (IM) of Allogeneic PLX-PAD Cells for the Treatment of Critical Limb Ischemia (CLI)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Pluristem Ltd.
ClinicalTrials.gov Identifier:
NCT00951210
First received: August 3, 2009
Last updated: November 24, 2011
Last verified: November 2011
  Purpose

The purpose of this study is to determine the safety of PLX-PAD, Intra-muscular injections for the treatment of CLI patients.


Condition Intervention Phase
Peripheral Artery Disease
Peripheral Vascular Disease
Critical Limb Ischemia
Biological: PLX-PAD
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) Injections 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.

Resource links provided by NLM:


Further study details as provided by Pluristem Ltd.:

Primary Outcome Measures:
  • Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]
  • Immunological reaction [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 12
Study Start Date: August 2009
Study Completion Date: October 2011
Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: PLX-PAD low dose
IM injection Single treatment; multiple injections
Biological: PLX-PAD
IM injection
Experimental: PLX-PAD high dose
IM injection Double treatment; multiple injections
Biological: PLX-PAD
IM injection

  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 < 0.6 or/and TBI < 0.4
  2. Rutherford category 4-5
  3. Non candidate for revascularization or endovascular intervention based on unfavorable vascular anatomy or significant co-morbid medical conditions as confirmed by vascular study (e.g., angiogram, MRA) obtained within 3 months prior screening visit and signed approval of vascular surgeon. The decision to classify the subject as a non-candidate will be made by the investigator and confirmed by an independent third party vascular surgeon who is not participating in the study.
  4. In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
  5. Those diabetic subjects who are on optimal diabetes medication, with an HbA1c < 8%

Exclusion Criteria:

  1. Uncontrolled hypertension (defined as diastolic blood pressure > 110 mmHg or systolic blood pressure > 180 mmHg during screening).
  2. Wounds with severity greater than Grade 2 on the Wagner Scale
  3. Life-threatening ventricular arrhythmia - except if an ICD is implanted - or unstable angina - characterized by increasingly frequent episodes with modest exertion or at rest, worsening severity, and prolonged.
  4. 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)
  5. In the opinion of the investigator, the patient is unsuitable for cellular therapy.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00951210

Locations
United States, Alabama
Cardiology PC
Birmingham, Alabama, United States, 35211
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Pluristem Ltd.
  More Information

No publications provided

Responsible Party: Pluristem Ltd.
ClinicalTrials.gov Identifier: NCT00951210     History of Changes
Other Study ID Numbers: 1202-2
Study First Received: August 3, 2009
Last Updated: November 24, 2011
Health Authority: United States: Food and Drug Administration

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 August 28, 2014