MarrowStim P.A.D. Kit
For Critical Limb Ischemia (CLI) in subjects with severe Peripheral Arterial Disease (PAD)
An FDA-Approved Research Trial
The MarrowStim P.A.D. Kit is an Investigational Device that is not approved by the Food and Drug Administration (FDA). The purpose of this research is to study the safety and effectiveness of a new 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 hip bones and concentrated with the MarrowStim P.A.D. Kit. Concentrated bone marrow aspirate contains mononuclear cells that may have the potential to treat diseased vascular structures.
Study participants will be randomized to receive either MarrowStim treatment or placebo. Three out of every four participants (75%) will receive MarrowStim treatment and one out of every four (25%) will receive placebo. MarrowStim treatment involves the administration of concentrated bone marrow aspirate to the patient's affected limb.
|MarrowStim Device||MarrowStim Treatment|
Patients meeting the pre-defined inclusion/exclusion criteria are eligible for this clinical trial.
For more information, call toll free 877-788-3972 or contact one of the study locations listed below.ARKANSAS
Central Arkansas Veterans Healthcare System
Little Rock, Arkansas
Contact: Sandra Brock
University of California - Davis Medical Center
Contact: Christy Pifer
University of Miami
Contact: Lynne Sparling
University of Iowa Hospitals and Clinics
Iowa City, Iowa
Contact: Emily Avgenackis
University of Louisville
Contact: Diane DeLong
Grand Rapids, Michigan
Contact: Jeanine Holen
New York Presbyterian Hospital â€“ Weill Cornell Medical College
New York, New York
Contact: Ruchita Mehta
The Cleveland Clinic
Contact: Jennifer Seaber
University Hospitals Case Medical Center
Contact: Lori Hammer
Providence Sacred Heart Medical Center
Contact: Claudia Flores
Study location information will be added to this section as it becomes available.
If you think you may qualify to participate in this study, please refer to the website link below to obtain further information about participation.
For additional information on this study, please refer to the website link below from ClinicalTrials.gov: