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

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.

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00951210

Enrollment

Registered

2009-08-04

Start date

2009-08-31

Completion date

2011-10-31

Last updated

2015-05-27

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, PAD, CLI

Brief summary

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

Interventions

BIOLOGICALPLX-PAD

IM injection

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 \< 0.6 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.

Design outcomes

Primary

Measure	Time frame
Adverse events; Amputation incidence, Death incidence & Rehospitalization incidence	3 months
Immunological reaction	3 months

Countries

United States

Outcome results

None listed

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