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

Clinical Trial Details

This is a prospective, single-arm, multicenter trial designed to further evaluate the performance of the MarrowStim™ PAD Kit to treat critical limb ischemia (CLI) in subjects deemed unsuitable for revascularization. If subjects become eligible for conventional revascularization (i.e. bypass, PTA, etc.) following enrollment (due to improvement of condition, change of circumstances, etc.), they will not be denied treatment.

Key Eligibility: 
  • Men and women 21 years and older
  • 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

Study contact by location

Upper East Side - Manhattan

Contact(s)

Eniola Odukale
(646) 962-8444
eno4001@med.cornell.edu

Primary Investigator(s)

Protocol ID(s)

Weill Cornell Medicine IRB #:

1512016851

ClinicalTrials.gov:

NCT02474121

Sponsor:

BB-IDE 13996

Status

Open to Enrollment

Age Group

Adult

Sponsor

Disease