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

NCT00919958 | Completed Phase 1 DMC

• 1 other identifier: PLX-PAD 1202-1
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Peripheral Artery Disease; Peripheral Vascular Disease; Critical Limb Ischemia

Keywords

Peripheral Artery Disease; Peripheral Vascular Disease; Critical limb ischemia

Outcome Measures

Primary Outcomes (2)

• Adverse events, Safety laboratory values and ECG findings

  3 months

• Immunological reaction

  1 month

Secondary Outcomes (1)

• Tumorigenesis

  24 months

Study Arms (3)

PLX-PAD low dose

EXPERIMENTAL

Biological: PLX-PAD IM injection

PLX-PAD intermediate dose

EXPERIMENTAL

Biological: PLX-PAD IM injection

PLX-PAD high dose

EXPERIMENTAL

Biological: PLX-PAD IM injection

Interventions

PLX-PAD IM injection BIOLOGICAL

Single treatment; multiple injections

PLX-PAD high dose; PLX-PAD intermediate 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 \< 0.4 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Pluristem Ltd.: lead

Study Sites (1)

Franziskus-Krankenhaus

Berlin, Germany

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 Officials

• Prof. Carsten Tschöpe, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

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: June 10, 2009
• First Posted: June 12, 2009
• Study Start: June 1, 2009
• Primary Completion: June 1, 2012
• Study Completion: June 1, 2012
• Last Updated: June 19, 2012

Record last verified: 2012-06

Locations

DE (1)