Biomet Biologics

For Referring Physicians

Enrollment in the clinical study described below is now closed. Treatment with the MarrowStim™ PAD Kit may be available through a continued access study. More information about this including open sites can be found here.

Clinical Trial Overview

The purpose of this research is to study the safety and effectiveness of an investigational treatment for patients suffering from severe peripheral arterial disease (PAD) utilizing their own concentrated bone marrow aspirate. The bone marrow aspirate is obtained from the patient's pelvis and concentrated with the investigational device. Concentrated bone marrow aspirate contains mononuclear cells that may have the potential to treat diseased vascular structures39.

With your help, we can study CLI patients with limited treatment options and potentially identify better options for those affected by this condition in the future.

- Dr. Michael Murphy, M.D., lead investigator of the MOBILE Study

Clinical Trial Design

Study participants will be randomized to receive either investigational treatment with concentrated bone marrow aspirate or placebo. Three out of every four participants (75%) will receive investigational treatment and one out of every four (25%) will receive placebo. The listing below contains the major inclusion/exclusion criteria for the trial. The trial site will screen referred patients per the specific inclusion/exclusion criteria as defined in the clinical trial protocol.

Patient Inclusion/Exclusion

Inclusion

  • Patient has lower extremity ischemia due to advanced peripheral arterial disease, is competent to give consent, and is 21 years of age or older
  • Patients considered unsuitable for revascularization due to unfavorable arterial anatomy, failed previous bypass, 2 or more failed endovascular attempts, or absence of an adequate autogenous vein
  • Patient has minor tissue loss of the index limb (Rutherford Category 5); OR ischemic rest pain of the index limb (Rutherford Category 4)
  • Patient has no current malignancy or history of previous malignancy within last five years, with exception of adequately treated non-melanoma skin cancer

Exclusion

  • Major tissue loss of the index limb (Rutherford Category 6)
  • Diabetic patient with uncontrolled or untreated proliferative retinopathy
  • Renal disease (creatinine > 2.5 mg/dl) or chronic hemodialysis
  • Lower extremity venous disease with pitting edema in the index leg
  • Recent history (in previous 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
  • Known HIV, organ transplant, or terminal disease w/life expectancy < 1 year

Trial Sites

If you have a patient you think is a potential candidate for the MarrowStim™ PAD Clinical Trial sponsored by Biomet, please refer your patient to one of the following participating trial sites. For additional information on the trial please visit:

http://clinicaltrials.gov/ct2/show/NCT01049919

ARKANSAS
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas
Contact: Sandra Brock
Phone: 501-257-6906
Email: brocksandraj@uams.edu

CALIFORNIA
University of California - Davis Medical Center
Sacramento, California
Contact: Christy Pifer
Phone: 916-734-4156
Email: christy.pifer@ucdmc.ucdavis.edu

FLORIDA
University of Miami
Miami, Florida
Contact: Lynne Sparling
Telephone: 305-243-7298
Email: lsparlin@med.miami.edu


GEORGIA
Piedmont Hospital
Atlanta, Georgia
Contact: Charles B. Ross, M.D., F.A.C.S.
Chief, Vascular and Endovascular Surgery
Telephone: 404-605-5699
Email: charles.ross@piedmont.org

ILLINOIS

Northwestern University
Chicago, Illinois
Contact: Daniel Roshevsky
Telephone: 312-695-3264
Email: droshevs@nmh.org

Southern Illinois University
Springfield, Illinois
Contact: Tiffany Whitaker
Telephone: 217-545-2531
Email: twhitaker@siumed.edu

INDIANA

Indiana University School of Medicine
Indianapolis, Indiana
Contact: Kristen Wanczyk
Telephone: 317-988-9548
Email: keevans@iu.edu

IOWA

University of Iowa Hospitals and Clinics
Iowa City, Iowa
Contact: Judith Pena-Quevedo
Telephone: 319-353-8736
Email: judith-pena-quevedo@uiowa.edu


KENTUCKY
University of Louisville
Louisville, Kentucky
Contact: Shari Williams
Telephone: 502-407-3259
Email: slwill06@lousiville.edu

MASSACHUSETTS
UMASS Memorial Medical Center
Worcester, Massachusetts
Contact: Shauneen Valliere
Telephone: 508-856-1767
Email: shauneen.valliere@umassmed.edu

Tuft's Medical Center
Boston, MA
Contact: Erica Tangney
Telephone: 617-636-8404
Email: etangney@tuftsmedicalcenter.org

Brigham & Women's Hospital
Boston, MA
Contact: Yasser Motii
Telephone: 617-525-8555
Email: ymotii@partners.org


MICHIGAN
Spectrum Health
Grand Rapids, Michigan
Contact: Jeanine Holen
Telephone: 616-391-5067
Email: jeanine.holen@spectrumhealth.org

MISSOURI

Saint Luke's Hospital
Kansas City, MO
Contact: Paul Kennedy
Telephone: 816-932-8667
Email: pkennedy@saint-lukes.org

NEBRASKA
Nebraska-Western Iowa VA Healthcare System
Omaha, NE
Contact: Holly DeSpiegelaere
Telephone: 402-995-4171
Email: holly.despiegelaere@va.gov

NEW JERSEY
Holy Name Medical Center
Teaneck, New Jersey
Contact: Yitzchak David
Telephone: 201-833-7968
Email: y-david@holyname.org

NEW YORK
New York Presbyterian Hospital Weill Cornell Medical College
New York, New York
Contact: Ruchita Mehta
Telephone: 212-746-5949
Email: rum2006@med.cornell.edu

The Mount Sinai Hospital
New York, New York
Contact: Erin Bresnahan
Telephone: 212-241-8250
Email: erin.bresnahan@mountsinai.org

OHIO
The Cleveland Clinic
Cleveland, Ohio
Contact: Jennifer Seaber
Phone: 216-445-8063
Email: seaberj@ccf.org

University Hospitals Case Medical Center
Cleveland, Ohio
Contact: Lori Hammer
Telephone: 216-983-4719
Email: lori.hammer@uhhospitals.org

Remington-Davis
Columbus, Ohio
Contact: Jennifer M. Botte
Telephone: 614-487-2560
Email: jbotte@remdavis.com

PENNSYLVANIA

Temple University Hosptial
Philadelphia, Pennsylvania
Contact: Steve Lucas
Phone: 215-707-4841
Email: steven.lucas@tuhs.temple.edu

VA Pittsburgh Healthcare System
Pittsburgh, Pennsylvania
Contact: Jennifer Carrick, RN
Phone: 412-360-3653
Email: Jennifer.Carrick@va.gov

TEXAS
Houston Methodist Hospital
Houston, TX
Contact: Kim Donlon
Telephone: 713-441-9394
Email: kdonlon@houstonmethodist.org

VIRGINIA
University of Virginia Hospital
Charlottesville, Virginia
Contact: Robyn McKenzie
Telephone: 434-982-1058
Email: RRM5F@hscmail.mcc.virginia.edu

WASHINGTON
Providence Sacred Heart Medical Center
Spokane, Washington
Contact: Joan Milton
Telephone: 509-474-4323
Email: joan.e.milton@providence.org

WASHINGTON, DC
Medstar Research Institute
Washington, DC
Contact: Suman Singh
Telephone: 202-877-8475
Email: suman.singh@medstar.net

WISCONSIN
Aurora St. Luke's Medical Center
Milwaukee, Wisconsin
Contact: Valerie Williams
Telephone: 414-649-6853
Email: valerie.williams@aurora.org

Caution - Investigational Device

The use of concentrated bone marrow aspirate derived from the MarrowStim™ PAD Kit has not been cleared or approved by the United States Food and Drug Administration for any clinical use. Specifically, the use of concentrated bone marrow aspirate for the treatment of Critical Limb Ischemia caused by Peripheral Arterial Disease is investigational and has not been evaluated by the United States Food and Drug Administration.