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

• ClinicalTrials.gov Identifier: NCT02474121
• Expanded Access Status: No longer available
• First Posted: June 17, 2015
• Last Update Posted: July 3, 2019
• Sponsor: Zimmer Biomet
• Information provided by (Responsible Party): Zimmer Biomet

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment
Peripheral Arterial Disease; Peripheral Vascular Diseases; Critical Limb Ischemia	Device: Bone marrow concentration device

Detailed Description:

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.

Study Design

• Study Type: Expanded Access
• Official Title: MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access

Interventions

Intervention Details:

• Device: Bone marrow concentration device
  Collection of autologous bone marrow aspirate and point-of-care concentration using the bone marrow concentration device, followed by intramuscular injection of concentrated bone marrow aspirate (cBMA) into the affected limb
  Other Names:

  • MarrowStim™ PAD Kit
  • Bone Marrow Concentrate
  • Bone Marrow Mononuclear Cells

Eligibility Criteria

• Ages Eligible for Study: 21 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All

Criteria

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.

Contacts and Locations

Locations

United States, Arkansas

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, United States, 72205

United States, Georgia

Piedmont Hospital

Atlanta, Georgia, United States, 30309

United States, Indiana

Indiana University

Indianapolis, Indiana, United States, 46202

United States, Massachusetts

Tufts Medical Center

Boston, Massachusetts, United States, 02111

United States, New Jersey

Holy Name Medical Center

Teaneck, New Jersey, United States, 07666

United States, New York

The Mount Sinai Hospital

New York, New York, United States, 10029

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, United States, 10065

United States, Ohio

Cleveland Clinic

Cleveland, Ohio, United States, 44195

United States, Pennsylvania

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, United States, 15240

Sponsors and Collaborators

Zimmer Biomet

More Information

Publications:

Murphy MP, Lawson JH, Rapp BM, Dalsing MC, Klein J, Wilson MG, Hutchins GD, March KL. Autologous bone marrow mononuclear cell therapy is safe and promotes amputation-free survival in patients with critical limb ischemia. J Vasc Surg. 2011 Jun;53(6):1565-74.e1. doi: 10.1016/j.jvs.2011.01.074. Epub 2011 Apr 22.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Wang SK, Green LA, Gutwein AR, Drucker NA, Babbey CM, Gupta AK, Fajardo A, Motaganahalli RL, Wilson MG, Murphy MP. Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites. J Vasc Surg. 2018 Aug;68(2):560-566. doi: 10.1016/j.jvs.2017.11.088. Epub 2018 Mar 1.

• Responsible Party: Zimmer Biomet
• ClinicalTrials.gov Identifier: NCT02474121 History of Changes
• Other Study ID Numbers: BB-IDE 13996 (CA)
• First Posted: June 17, 2015
• Last Update Posted: July 3, 2019
• Last Verified: July 2019

Additional relevant MeSH terms:

Vascular Diseases; Peripheral Arterial Disease; Peripheral Vascular Diseases; Ischemia; Pathologic Processes; Cardiovascular Diseases; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases