Use of Autologous Concentrated Bone Marrow Aspirate in Preventing Wound Complications in Below Knee Amputation (BKA)
NCT02863926 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 6
Last updated 2024-12-12
Summary
Patients scheduled for major extremity lower amputation to receive bone marrow cells (cBMA) injected IM in the leg proximal to the amputation in the index limb to prevent ischemic wound complications after surgery.
Conditions
- Peripheral Artery Disease
- Vascular Disease
- Critical Limb Ischemia
Interventions
- BIOLOGICAL
-
Injection of cBMA aspirate into the index leg
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery
Sponsors & Collaborators
-
Zimmer Biomet
collaborator INDUSTRY -
Michael Murphy
lead OTHER
Principal Investigators
-
Michael P Murphy, MD · Indiana University
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 90 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2017-01-06
- Primary Completion
- 2018-07-27
- Completion
- 2018-07-27
Countries
- United States
Study Locations
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