Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI) (MOBILE)
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|ClinicalTrials.gov Identifier: NCT01049919|
Recruitment Status : Terminated (Primary endpoint not met, remaining long-term follow-up not needed.)
First Posted : January 15, 2010
Results First Posted : May 28, 2021
Last Update Posted : May 28, 2021
|Condition or disease||Intervention/treatment||Phase|
|Critical Limb Ischemia Peripheral Arterial Disease Peripheral Vascular Disease||Device: Bone marrow concentration device Procedure: Placebo procedure (sham)||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||153 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||February 2020|
Experimental: Concentrated bone marrow aspirate (cBMA)
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
Device: Bone marrow concentration device
Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
Sham Comparator: Placebo control (sham)
Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
Procedure: Placebo procedure (sham)
Sham bone marrow aspiration, sham delivery to affected limb
- Occurrence of Major Amputation or Death [ Time Frame: 52 weeks ]Occurrence of major amputation (above the ankle joint) or death.
- Visual Analog Scale (VAS) - Pain [ Time Frame: 52 weeks ]Pain reported at the 52-week follow-up visit as assessed on the visual analog scale (VAS). Scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" and "worst pain." The distance from the beginning of the line is measured and reported in centimeters (cm), with 0 representing no pain and 10 representing the worst possible pain.
- Six-Minute Walk Test [ Time Frame: 52 weeks ]Measurement (in meters) of the total distance a participant is able to walk in 6 minutes. Since ability to walk is related to the condition of the affected limb, this measure is tied to limb pain and function. If a participant had multiple limbs included in the study, each limb was evaluated separately. Only one limb could be included in the study at a time.
- Occurrence of Major Amputation or Death [ Time Frame: 5 years ]Occurrence of major amputation (above the ankle joint) or death for all participants through final follow-up.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049919
|Principal Investigator:||Michael P. Murphy, MD||Indiana University School of Medicine|