At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 6 enrolled
Drug / intervention
Injection of cBMA aspirate into the index legbiological
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Safety and Efficacy of Concentrated Autologous Concentrated Bone Marrow Aspirate (cBMA) in Preventing Wound Complications in Below Knee Amputation (BKA) (The MarrowCHAMP Study)
In Brief
A Phase 1 clinical trial evaluating Injection of cBMA aspirate into the index leg for Peripheral Artery Disease and 2 related conditions. Completed, enrolled 6 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
CollaboratorsZimmer Biomet
Timeline
Phase 1CompletedFinished
2017201820192020202120222023202420252026
First PostedAug 2016
Enrollment StartJan 2017
Primary CompletionJul 2018
TodayJul 2026
First PostedAug 11, 2016
Enrollment StartJan 6, 2017
Primary CompletionJul 27, 2018
TodayJul 2, 2026
Enrollment to primary: 1.6 yearsPosted 9.9 years ago
Interventions
Injection of cBMA aspirate into the index legbiological
Injection of cBMA into the anterior tibialis muscle and upper index leg of subjects scheduled for semi-elective BKA 7-21 days before surgery