Clinical trial NCT00919958: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Peripheral Artery Disease
Peripheral Vascular Disease
Critical Limb Ischemia
Keywords: Peripheral Artery Disease
Peripheral Vascular Disease
Critical limb ischemia
Lead sponsor: Pluristem Ltd.
Sponsor class: INDUSTRY
First posted: 2009-06-12
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: Adverse events, Safety laboratory values and ECG findings
timeFrame: 3 months
measure: Immunological reaction
timeFrame: 1 month
Secondary outcomes:
measure: Tumorigenesis
timeFrame: 24 months
Other outcomes:
Locations:
city: Berlin
country: Germany
facility: Franziskus-Krankenhaus
Study officials:
affiliation: Charite University, Berlin, Germany
name: Prof. Carsten Tschöpe, MD
role: PRINCIPAL_INVESTIGATOR
References: