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Trial record 20 of 34 for:    stem cell peripheral arterial disease AND marrow

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 : Active, not recruiting
First Posted : January 15, 2010
Last Update Posted : July 4, 2019
Sponsor:
Information provided by (Responsible Party):
Zimmer Biomet

Tracking Information
First Submitted Date  ICMJE January 14, 2010
First Posted Date  ICMJE January 15, 2010
Last Update Posted Date July 4, 2019
Study Start Date  ICMJE June 2010
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
Time to treatment failure [ Time Frame: 52 weeks ]
"Treatment failure" defined as the composite of major amputation of the index limb or death
Original Primary Outcome Measures  ICMJE Not Provided
Change History Complete list of historical versions of study NCT01049919 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 27, 2010)
Perfusion and quality of life measurements [ Time Frame: Throughout 52 week follow-up ]
ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, minor amputations, time to major amputation of the index limb, time to death
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures
 (submitted: May 12, 2014)
  • Long-term treatment failure [ Time Frame: 5 years ]
    Evaluations of long-term amputation-free survival will be assessed for a period of 5 years.
  • Long-term perfusion and quality of life measurements [ Time Frame: 3 years ]
    ABI, TBI, rest pain, 6 Minute Walk Test, VascuQol, SF-36, wound assessment, minor amputations, time to major amputation of the index limb, time to death
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Autologous Concentrated Bone Marrow Aspirate (cBMA) for Critical Limb Ischemia (CLI)
Official Title  ICMJE MarrowStim PAD Kit for the Treatment of Critical Limb Ischemia (CLI) in Subjects With Severe Peripheral Arterial Disease (PAD)
Brief Summary This trial will evaluate the safety and efficacy of concentrated bone marrow aspirate (cBMA) to prevent or delay major amputation and/or death in subjects with critical limb ischemia (CLI) due to severe peripheral arterial disease (PAD).
Detailed Description This is a prospective, randomized, double-blind, placebo controlled, multicenter trial intended for subjects with critical limb ischemia (CLI) that are unsuitable for revascularization. The investigational treatment utilizes autologous concentrated bone marrow aspirate (cBMA) at the point of care. The bone marrow aspirate is obtained from the subject's hip, concentrated with a bone marrow concentration device, and delivered intramuscularly to the affected limb. Subjects meeting the inclusion/exclusion criteria will be randomized to receive either the investigational treatment (cBMA) or a placebo control (sham treatment).
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Critical Limb Ischemia
  • Peripheral Arterial Disease
  • Peripheral Vascular Disease
Intervention  ICMJE
  • Device: Bone marrow concentration device
    Concentration of autologous bone marrow aspirate for intramuscular delivery to affected limb
    Other Names:
    • Bone marrow concentrate
    • Bone marrow mononuclear cells
    • MarrowStim
  • Procedure: Placebo procedure (sham)
    Sham bone marrow aspiration, sham delivery to affected limb
Study Arms  ICMJE
  • 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
    Intervention: Device: Bone marrow concentration device
  • Sham Comparator: Placebo control (sham)
    Placebo procedure (sham) consists of simulated bone marrow aspiration followed by simulated intramuscular injections into the affected limb
    Intervention: Procedure: Placebo procedure (sham)
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: September 27, 2010)
152
Original Enrollment  ICMJE Not Provided
Estimated Study Completion Date  ICMJE September 2020
Actual Primary Completion Date June 2016   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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) with ABI ≤ 0.6, or TBI ≤ 0.4, or TcPO2 ≤ 50 mm Hg
  • 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)

Exclusion Criteria:

  • Major tissue loss (Rutherford Category 6)
  • Diabetics on oral or insulin therapy with uncontrolled or untreated proliferative retinopathy (evidence of retinal exam required)
  • Poorly controlled diabetes mellitus with HbA1C > 10% (evidence of HbA1C test required)
  • Uncompensated congestive heart failure (New York Heart Association Class IV) 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 normal upper limit)
  • 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
  • Current osteomyelitis in index leg
  • Existing HIV diagnosis
  • Organ transplant recipients
  • Known terminal disease process with life expectancy less than one year
  • Severe concomitant disease(s) or any additional condition(s) which the investigator feels constitute(s) criteria for exclusion of a particular subject
  • Major amputation required within 30 days
  • Inclusion in any other clinical study that may affect the outcome of this study
  • Uncorrected stenosis(es) of greater than 50% in the common and/or external iliac artery and/or common femoral artery of the index leg.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01049919
Other Study ID Numbers  ICMJE BB-IDE 13996
BBIO.CR.CT002 ( Other Identifier: Biomet )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Zimmer Biomet
Study Sponsor  ICMJE Zimmer Biomet
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Michael P. Murphy, MD Indiana University School of Medicine
PRS Account Zimmer Biomet
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP