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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00919958

Enrollment

Registered

2009-06-12

Start date

2009-06-30

Completion date

2012-06-30

Last updated

2012-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critical Limb Ischemia, Peripheral Artery Disease, Peripheral Vascular Disease

Keywords

Peripheral Artery Disease, Peripheral Vascular Disease, Critical limb ischemia

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

Interventions

BIOLOGICALPLX-PAD IM injection

Single treatment; multiple injections

Study design

Allocation

NON_RANDOMIZED

Intervention model

FACTORIAL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

40 Years to 81 Years

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame
Adverse events, Safety laboratory values and ECG findings	3 months
Immunological reaction	1 month

Secondary

Measure	Time frame
Tumorigenesis	24 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026