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

NCT00951210 | Completed Phase 1 DMC

• 1 other identifier: 1202-2
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Keywords

Peripheral Artery Disease; Peripheral Vascular Disease; Critical limb ischemia; PAD; CLI

Outcome Measures

Primary Outcomes (2)

• Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence

  3 months

• Immunological reaction

  3 months

Study Arms (2)

PLX-PAD low dose

EXPERIMENTAL

IM injection Single treatment; multiple injections

Biological: PLX-PAD

PLX-PAD high dose

EXPERIMENTAL

IM injection Double treatment; multiple injections

Biological: PLX-PAD

Interventions

PLX-PAD BIOLOGICAL

IM injection

PLX-PAD high dose; PLX-PAD low dose

Eligibility Criteria

• Age: 40 Years - 81 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Rutherford category 4-5
• 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.
• In the opinion of the investigator, major amputation is not anticipated over a period of three (3) months.
• Those diabetic subjects who are on optimal diabetes medication, with an HbA1c \< 8%

You may not qualify if:

• Uncontrolled hypertension (defined as diastolic blood pressure \> 110 mmHg or systolic blood pressure \> 180 mmHg during screening).
• Wounds with severity greater than Grade 2 on the Wagner Scale
• 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.
• 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.

Sponsors & Collaborators

• Pluristem Ltd.: lead

Study Sites (2)

Cardiology PC

Birmingham, Alabama, 35211, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 3, 2009
• First Posted: August 4, 2009
• Study Start: August 1, 2009
• Primary Completion: January 1, 2011
• Study Completion: October 1, 2011
• Last Updated: May 27, 2015

Record last verified: 2011-11

Locations

US (2)