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

Conditions:Peripheral Vascular Disease, Peripheral Vascular Disease, Cardiology
Therapuetic Areas:Cardiology / Vascular Diseases
Age Range:21 - Any
Contact:Hillary Overholser

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MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access

This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat
subjects with critical limb ischemia (CLI) caused by severe PAD.

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

Inclusion Criteria:

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

- Unsuitable for revascularization

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

- 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

- 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

- 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.
We found this trial at
Little Rock, Arkansas 72205
Principal Investigator: Mohammed Moursi, MD
Phone: 501-257-6906
Little Rock, AR
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Principal Investigator: Mark Iafrati, MD
Phone: 617-636-8404
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
Boston, MA
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9500 Euclid Avenue
Cleveland, Ohio 44106
Principal Investigator: Lee Kirksey, MD
Phone: 216-444-5937
Cleveland Clinic Cleveland Clinic is committed to principles as presented in the United Nations Global...
Cleveland, OH
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425 University Blvd.
Indianapolis, Indiana 46202
(317) 274-4591
Principal Investigator: Michael Murphy, MD
Phone: 317-988-9548
Indiana University INDIANA UNIVERSITY is a major multi-campus public research institution, grounded in the liberal...
Indianapolis, IN
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1968 Peachtree Rd NW
Atlanta, Georgia 30309
(404) 605-5000
Principal Investigator: Charles Ross, MD
Phone: 404-605-4098
Piedmont Hospital For more than a century, Piedmont Healthcare has been a recognized leader in...
Atlanta, GA
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New York, New York 10029
Principal Investigator: Ageliki Vouyouka, MD
Phone: 212-241-8250
New York, NY
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New York, New York 10021
Principal Investigator: Peter Connolly, MD
Phone: 646-962-8440
New York, NY
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Pittsburgh, Pennsylvania 15240
Principal Investigator: Edith Tzeng, MD
Phone: 412-360-3653
Pittsburgh, PA
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Teaneck, New Jersey 07666
Principal Investigator: John Rundback, MD
Phone: 201-530-7967
Teaneck, NJ
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