Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access

This is a continued access enrollment intended for subjects with critical limb ischemia (CLI)
that are unsuitable for revascularization. The investigational treatment utilizes autologous
concentrated bone marrow aspirate (cBMA) at the point of care. The bone marrow aspirate is
obtained from the subject's hip, concentrated with a bone marrow concentration device, and
delivered intramuscularly to the affected limb. Subjects meeting the inclusion/exclusion
criteria will be treated with the MarrowStim™ PAD Kit and followed for a total of five years.
Information on subject outcomes, such as the occurrence of amputation and death, as well as
measurements of rest pain, blood flow (ankle-brachial index, toe-brachial index), and quality
of life will be collected. Safety information (via adverse event reporting) will also be
collected.

Inclusion Criteria:

- Unilateral or bilateral lower extremity ischemia due to advanced peripheral arterial
disease

- Unsuitable for revascularization

- Minor tissue loss (Rutherford Category 5) or ischemic rest pain (Rutherford Category
4)

- Competent to give consent

- No current malignancy or history of previous malignancy within the last five years,
with the exception of adequately treated non-melanoma skin cancer (evidence of
standard preventative cancer screenings required)

Exclusion Criteria:

- Major tissue loss (Rutherford Category 6)

- Diabetics with uncontrolled or untreated proliferative retinopathy

- Poorly controlled diabetes mellitus with HbA1C > 10%

- Uncompensated congestive heart failure and/or other conditions that preclude general
anesthesia

- Myocardial infarction or stroke within last 90 days

- Elevated liver function tests (AST or ALT more than twice the upper limit of normal)

- Renal disease (creatinine > 2.5 mg/dl) or chronic hemodialysis

- White blood cell count < 3,000/µL or > 15,000/µL, platelet count < 100,000/µL, or
hematocrit < 32%

- Topical growth hormone therapy within last 90 days, or injected growth hormone therapy
within last 180 days

- Disease of central nervous system and/or other conditions that impair cognitive
function

- Two or more episodes of pulmonary embolus with a documented DVT in index leg or
history of DVT in index leg without evidence of clot resolution

- Current infection of index leg

- Pregnant women (negative urine pregnancy test required)

- Lower extremity venous disease with pitting edema in index leg

- Recent history (in the 6 months prior to screening) of bone marrow disease or
treatment with any medication or procedure which adversely affects the bone marrow and
would prohibit transplantation

- Current osteomyelitis in index leg

- Existing HIV diagnosis

- Organ transplant recipients

- Known terminal disease process with life expectancy less than one year

- Severe concomitant disease(s) or any additional condition(s) which the investigator
feels constitute(s) criteria for exclusion of a particular subject

- Major amputation required within 30 days

- Inclusion in any other clinical study that may affect the outcome of this study

- Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac
artery and/or common femoral artery of the index leg.