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

NCT02474121 | Unknown

• 1 other identifier: BB-IDE 13996 (CA)
• Study Type: expanded_access
• Target: N/A
• Locations: 1 country
• Sites: 9

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.

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Critical Limb Ischemia

Interventions

Bone marrow concentration device 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

Also known as: MarrowStim™ PAD Kit, Bone Marrow Concentrate, Bone Marrow Mononuclear Cells

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Zimmer Biomet: lead

Study Sites (9)

Central Arkansas Veterans Healthcare System

Little Rock, Arkansas, 72205, United States

Location

Piedmont Hospital

Atlanta, Georgia, 30309, United States

Location

Indiana University

Indianapolis, Indiana, 46202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Holy Name Medical Center

Teaneck, New Jersey, 07666, United States

Location

The Mount Sinai Hospital

New York, New York, 10029, United States

Location

Weill Cornell Medical College/New York Presbyterian Hospital

New York, New York, 10065, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

VA Pittsburgh Healthcare System

Pittsburgh, Pennsylvania, 15240, United States

Location

Related Publications (2)

• 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.

  PMID: 21514773 BACKGROUND

• 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.

  PMID: 29503004 DERIVED

MeSH Terms

Conditions

Peripheral Arterial Disease; Peripheral Vascular Diseases; Chronic Limb-Threatening Ischemia

Condition Hierarchy (Ancestors)

Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Ischemia

Study Design

• Study Type: expanded access
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 17, 2015
• Last Updated: March 27, 2020

Record last verified: 2020-03

Locations

US (9)