Autologous Adipose-Derived Stromal Cell Delivered Via Intramuscular Injections for the Treatment of Critical Limb Ischemia

Inclusion Criteria:

- Age ~ 18 years

- Existence of limb ischemia, with clinical presentation corresponding to Rutherford
Categories 2-6 as defined in the reporting standards adopted by \ the Society of
Vascular Surgeons, or corresponding to the Leriche-Fontaine Classification, stages
II, III, or IV

- Patients with, ischemia and ischemic ulceration provided patient have angiographic
evidence of vascular compromise and is not a candidate for revascularization

- Stable and on optimal medical management for > 60 days as follows:

- Clopidogrel/aspirin therapy or other anticoagulation therapy, cholesterol- lowering
agent, and⁄or antihypertensive medication

- Hematocrit ≥ 28.0%, White Blood Cell count ≤14,000, Platelet count ≥ 50,000

- Creatinine ≤ 2.5 mg/dL, and INR ≤ 1.6 (unless taking warfarin) or PTT < 1.5× control
(to avoid bleeding complications). INR values for patients taking warfarin will be
corrected prior to the procedure

- Patient meets at least one of the following diagnostic criteria for the index limb:

1. ABI<.5mmHg

2. TcpO2 <20 mm Hg when lying down and breathing room air, if available

3. Or, nonhealing ulcer due to local arterial compromise with no opportunity for
revascularization

- At least one non-healing distal extremity ischemic ulcer as confirmed by a vascular
surgeon

- Up to date on all age and gender appropriate cancer screening per American Cancer
Society

Exclusion Criteria:

- Female who is pregnant or nursing, or is of childbearing potential and not using a
reliable method of contraception

- Any medical problems contraindicating tumescent syringe liposuction

- Life expectancy < 6 months

- Patient determined to be nonsurgical candidate due to reasons such as

1. High-risk medical conditions

2. Unstable cardiac disease

3. Stroke or transient ischemic attack leading to limitations in lower extremities
or occurring within 180 days prior to the initial screening visit

4. Severe arthritis or other musculoskeletal disorder.

- Systolic blood pressure (supine) ≤ 90 mmHg

- Resting heart rate > 100 bpm

- Poorly controlled diabetes mellitus (HgbA1c > 10%)

- Life‐threatening complications of limb ischemia necessitating immediate amputation

- Uncorrected iliac artery occlusion on index side unless corrected with stent

- Extensive necrosis of the index limb or other conditions that make amputation
inevitable (Rutherford Category 6)

- Active clinical infection within one week of enrollment

- Treatment with immunosuppressant drugs

- Known drug or alcohol dependence, or any other factors which will interfere with the
study conduct or interpretation of the results

- Not suitable to participate in the opinion of the principal investigator

- History cancer (other than non-melanoma skin cancer or in situ cervical cancer)
within five years preceding study entry

- Unwilling and/or not able to give written informed consent