Biomet Biologics

Clinical Trial

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.

Study Purpose

The MOBILE Study is investigating a device called the MarrowStim™ PAD Kit for patients who have critical limb ischemia (CLI), a condition where blood flow to the leg and foot is limited. The investigational treatment includes removal of some bone marrow from the hips, which is then processed in the investigational device to separate the stem cells for delivery by injection to multiple sites in the affected leg. The goal of the study is to evaluate the efficacy of the MarrowStim™ PAD Kit to prevent or delay major amputation and/or death by restoring blood flow and renewing circulation to the leg and foot.

Study Design

The MOBILE Study randomizes patients to receive either MarrowStim™ treatment or a placebo (false treatment). Three out of every four patients will receive the investigational MarrowStim™ treatment, while one out of every four will receive the placebo (false) treatment. All patients regardless of treatment group will receive general anesthesia.

For the investigational treatment group, bone marrow will be drawn from the hips and processed in the investigational device to separate the stem cells, which will be delivered to multiple sites in the affected leg in an attempt to restore blood flow and renew circulation to the leg and foot.

The placebo group will undergo a similar procedure that will mimic the MarrowStim™ procedure, but will not have bone marrow extracted. Subjects assigned to the placebo may be eligible to receive the investigational treatment after the 52 week office visit if they continue to meet certain criteria for entry in the study.

The procedure will require an in-person visit and will take about one to two hours. In-person follow-up visits are then required at weeks 6, 12, 24, 36, and 52 following the original procedure. An in-person visit is also required at years two and three following the original procedure.

Phone call follow-up is required at weeks 3, 9, 18, 30, and 44 following the original procedure. Phone call follow-up is also required at years four and five following the original procedure.

Aspirate - Process - Concentrate - Deliver

Study Participation

Are you a candidate for the MOBILE Study? Ask yourself these three questions:

  1. Do you have leg and foot pain that doesn't go away, even at night?
  2. Do you have sores on your legs that won't heal?
  3. If you have been diagnosed with CLI, has your doctor told you that there are no other reasonable treatment options available to you that would preserve the limb?

If any of these statements apply to you, please contact your healthcare professional to learn more about PAD and CLI.

Study Risks

Potential risks associated with participating in the MOBILE Study may include minimal discomfort or bruising from drawing blood, anemia (low red blood cell count), minor complications from bone marrow extraction, hip soreness following treatment, flu-like symptoms for the first several days after the procedure, tenderness of the calf or leg, potential blood clots in veins, allergic reactions to the treatment, and infection. The trial is registered with the FDA and patients are carefully monitored for adverse (negative) effects and treated accordingly throughout the duration of the study.

Study Locations

Please contact the following locations for more information on this clinical trial or click here for a complete list of trial sites: 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, NJ
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

FAQs

What causes PAD/CLI?

Peripheral arterial disease (PAD) occurs when cholesterol and a fatty material called plaque collect in the blood vessels and restrict blood flow to the limbs1,37. The resulting limited blood supply can lead to critical limb ischemia (CLI). CLI may present with pain in the legs while at rest, unexplained leg pain, sores or ulcers that don't heal4, gangrene, thickening of the toenails and a lack of pulse in the affected area6. Gangrene and ulcers that won't heal due to CLI can potentially require amputation of the affected limb6.

How do I know if I have PAD?

Symptoms of PAD are often overlooked as signs of increasing age. Common symptoms include fatigue, heaviness, tiredness, cramping in the legs, or pain and discomfort that goes away once activity is stopped37. Additional symptoms can include ulcers or sores on the feet or toes that are slow to heal3-5, numbness in the legs or feet when not moving3,6, gangrene31, shiny skin and thick or slower growth of toenails1,32.

How is PAD diagnosed?

  • Medical and Family History37
  • Physical Exam1,5,31,37
  • A combination of the following Screening Tests37
    • Ankle-brachial index (ABI)2,5,31,37
    • Doppler ultrasound37
    • Angiography1-2,31
    • Blood Test1

What is the most common treatment for PAD?37

The most common treatment for PAD is lifestyle changes followed by medication and sometimes specialty surgical procedures.

What is the MOBILE Study?

The MOBILE Study is investigating a device called the MarrowStim™ PAD Kit for people like you who have critical limb ischemia (CLI), a condition where blood flow to the leg and foot is limited. The investigational treatment includes removal of some bone marrow from your hips, which is then processed in the investigational device to separate the stem cells for delivery by injection to multiple sites in your affected leg. The goal of the study is to evaluate the efficacy of the MarrowStim™ PAD Kit to prevent or delay major amputation and/or death by restoring blood flow and renewing circulation to your leg and foot.

What is the treatment process for the MOBILE Study?

The investigational treatment involves withdrawal of bone marrow from your hips which is then processed in the investigational device to separate the stem cells. The stem cells are then delivered via injections to multiple sites in the affected leg in an attempt to restore blood flow and to renew circulation to your leg and foot. The MarrowStim™ PAD Kit treatment process takes about one to two hours. Three out of every four patients will receive the investigational treatment, while one out of four will receive a placebo (false) treatment. In-person follow-up visits are required at weeks 6, 12, 24, 36, and 52, and years 2 and 3, following the original procedure. Phone call follow-up is required at weeks 3, 9, 18, 30, and 44, and at years 4 and 5, following the original procedure.

Where are the stem cells taken from? Are they embryonic?

No, the stem cells are not embryonic, but taken from your own bone marrow in your hips.



How will I know if the treatment is working or not?

The study is designed in a way that doesn't allow you to know if you're receiving a placebo or the experimental treatment. Once the trial period is over, the physician will be able to tell you if you received the treatment or placebo, and if the treatment worked for you.

What is the chance I will receive a placebo?

There is a one in four chance you will receive placebo, however if you are placed in the placebo group, you may have an opportunity following the 52 week office visit to receive the investigational treatment if you continue to meet certain entry criteria for entry in the study.

What are the risks involved with participating in the MOBILE Study?

Potential risks associated with participating in the MOBILE Study may include minimal discomfort or bruising from drawing blood, anemia (low red blood cell count), minor complications from bone marrow extraction, hip soreness following treatment, flu-like symptoms for the first several days after the procedure, tenderness of the calf or leg, potential blood clots in veins, allergic reactions to the treatment, and infection. The trial is registered with the FDA and patients are carefully monitored for adverse (negative) effects and treated accordingly throughout the duration of the study.

How long will the MOBILE Study take?

The study will take one year from the time of the initial procedure to evaluate the primary goal. Follow-up will be required until five years following the original procedure.

Where are the study sites?

The clinical trial sites include some of the most highly-respected medical institutions in the country, experienced in treating this condition. Review the complete list of trial sites here to identify a clinical trial site near you.

What would make me a candidate for the MOBILE Study?

First review these three questions as a pre-screening for your eligibility:

1) Do you have leg and foot pain that doesn't go away, even at night?

2) Do you have sores on your legs or feet that won't heal?

3) If you have been diagnosed with CLI, has your doctor told you that there are no other reasonable treatment options available to you that would preserve the limb?

If any of these statements apply to you, please contact your healthcare professional to learn more about PAD and CLI. To see if you qualify for the MOBILE Study, click here and call 877-788-3972.

How do I register for the MOBILE Study?

Once you have identified a clinical trial site, you can contact the site coordinator directly to begin the screening process.

Am I enrolled automatically once I contact the clinical trial site?

No, once you contact the clinical trial site you will have to undergo a thorough screening process to confirm if you qualify for the trial. If you qualify, you will be asked to begin the five-year commitment in the trial.

How often do I need to come to the study site?

You will be required to visit the clinical trial site a minimum of eight times, including the treatment visit, over the course of the study. After the 52 week visit, you will be required to visit the site for two additional follow-up office visits. The first will take place at two years and the second will take place at three years after the original procedure.

Do I need health insurance to participate in this trial?

In many cases, you do not need health insurance to participate in this trial. If you qualify and are enrolled in the clinical trial, the sponsor will cover all medical costs associated with the study including the pre-screening, the procedure, and post-procedure follow up.

Will I be reimbursed for my participation in the MOBILE Study and any travel costs to get to the trial site?

If you enroll in the MOBILE Study, you may be reimbursed for your time and travel costs up to $200 per completed visit for a total of $1,800.

What is an informed consent form? Who can address my questions about it, if I have any?

The informed consent is a form you must sign before enrolling in the clinical trial. Prior to enrollment, a healthcare professional from the study site, likely the study investigator or study coordinator, will review the form with you and outline the clinical trial process and your role in it, the likelihood that you'll receive the investigational treatment or a placebo, and all risks associated with participating in the trial. If you have any questions, you can call 877-788-3972.

Can I leave the MOBILE Study at any time?

You should not enroll in the trial unless you are willing and able to honor the time commitment of the trial of a minimum of eight in-person office visits, including the treatment visit and seven follow-up phone calls over the course of the study. However, you are free to leave the study at any time.

How will my progress be monitored once the MOBILE Study is complete?

During the MOBILE Study you will remain under your primary physician's care for all medical conditions not related to CLI. Following the trial, we ask you to continue to see your primary physician to monitor all your health related questions and concerns, as they arise. If you are placed in the placebo group, you will have an opportunity to receive the investigational treatment if you continue to meet certain criteria for entry in the study.

Will results of the MOBILE Study be provided to me?

Not immediately. Once the study is complete, it will take time for the study sponsors at Biomet Biologics, LLC to compile the results. When the results are complete, they are typically published for public knowledge.