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

Sponsor

Zimmer Biomet (Industry)

Overall Status

No longer available

CT.gov ID

NCT02474121

Collaborator

(none)

Locations

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Peripheral Arterial Disease Peripheral Vascular Diseases Critical Limb Ischemia	Device: Bone marrow concentration device

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.

Study Design

Study Type:

Expanded Access

Official Title:

MarrOwStim™ PAD Kit for the Treatment of Critical LimB IschemIa (CLI) in Subjects With Severe Peripheral ArteriaL DiseasE (PAD) (MOBILE) - Continued Access

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years and Older

Sexes Eligible for Study:

All

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

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Central Arkansas Veterans Healthcare System	Little Rock	Arkansas	United States	72205
2	Piedmont Hospital	Atlanta	Georgia	United States	30309
3	Indiana University	Indianapolis	Indiana	United States	46202
4	Tufts Medical Center	Boston	Massachusetts	United States	02111
5	Holy Name Medical Center	Teaneck	New Jersey	United States	07666
6	The Mount Sinai Hospital	New York	New York	United States	10029
7	Weill Cornell Medical College/New York Presbyterian Hospital	New York	New York	United States	10065
8	Cleveland Clinic	Cleveland	Ohio	United States	44195
9	VA Pittsburgh Healthcare System	Pittsburgh	Pennsylvania	United States	15240