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Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access (MOBILE-CA)

Primary Purpose

Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia

Status
No longer available
Phase
Locations
United States
Study Type
Expanded Access
Intervention
Bone marrow concentration device
Sponsored by
Zimmer Biomet
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an expanded access trial for Peripheral Arterial Disease

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All Sexes

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)
  • 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 with uncontrolled or untreated proliferative retinopathy
  • Poorly controlled diabetes mellitus with HbA1C > 10%
  • Uncompensated congestive heart failure 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 the upper limit of normal)
  • 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.

Sites / Locations

  • Central Arkansas Veterans Healthcare System
  • Piedmont Hospital
  • Indiana University
  • Tufts Medical Center
  • Holy Name Medical Center
  • The Mount Sinai Hospital
  • Weill Cornell Medical College/New York Presbyterian Hospital
  • Cleveland Clinic
  • VA Pittsburgh Healthcare System

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 15, 2015
Last Updated
March 26, 2020
Sponsor
Zimmer Biomet
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1. Study Identification

Unique Protocol Identification Number
NCT02474121
Brief Title
Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access
Acronym
MOBILE-CA
Official Title
MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access
Study Type
Expanded Access

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
No longer available
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Zimmer Biomet

4. Oversight

5. Study Description

Brief Summary
This study will continue to evaluate the performance of the MarrowStim™ PAD Kit to treat subjects with critical limb ischemia (CLI) caused by severe PAD.
Detailed Description
This is a continued access enrollment 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 treated with the MarrowStim™ PAD Kit and followed for a total of five years. Information on subject outcomes, such as the occurrence of amputation and death, as well as measurements of rest pain, blood flow (ankle-brachial index, toe-brachial index), and quality of life will be collected. Safety information (via adverse event reporting) will also be collected.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Peripheral Arterial Disease, Peripheral Vascular Diseases, Critical Limb Ischemia

7. Study Design

8. Arms, Groups, and Interventions

Intervention Type
Device
Intervention Name(s)
Bone marrow concentration device
Other Intervention Name(s)
MarrowStim™ PAD Kit, Bone Marrow Concentrate, Bone Marrow Mononuclear Cells
Intervention Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Eligibility Criteria
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) 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 with uncontrolled or untreated proliferative retinopathy Poorly controlled diabetes mellitus with HbA1C > 10% Uncompensated congestive heart failure 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 the upper limit of normal) 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.
Facility Information:
Facility Name
Central Arkansas Veterans Healthcare System
City
Little Rock
State/Province
Arkansas
ZIP/Postal Code
72205
Country
United States
Facility Name
Piedmont Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
Indiana University
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46202
Country
United States
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Holy Name Medical Center
City
Teaneck
State/Province
New Jersey
ZIP/Postal Code
07666
Country
United States
Facility Name
The Mount Sinai Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Weill Cornell Medical College/New York Presbyterian Hospital
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
VA Pittsburgh Healthcare System
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15240
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
21514773
Citation
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.
Results Reference
background
PubMed Identifier
29503004
Citation
Wang SK, Green LA, Gutwein AR, Drucker NA, Babbey CM, Gupta AK, Fajardo A, Motaganahalli RL, Wilson MG, Murphy MP. Ethnic minorities with critical limb ischemia derive equal amputation risk reduction from autologous cell therapy compared with whites. J Vasc Surg. 2018 Aug;68(2):560-566. doi: 10.1016/j.jvs.2017.11.088. Epub 2018 Mar 1.
Results Reference
derived

Learn more about this trial

Safety and Efficacy of Autologous Concentrated Bone Marrow Aspirate for Critical Limb Ischemia - Continued Access

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