Trials / Completed
CompletedNCT00595257
Feasability Study of Autologous Bone Marrow Aspirate Concentrate for Treatment of CLI
Feasibility Study of the Safety and Activity of Autologous Bone Marrow Aspirate Concentrate (BMAC) for the Treatment of Non Reconstructable Critical Limb Ischemia Due to Peripheral Arterial Occlusive Disease
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- Harvest Technologies · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to determine if concentrated nucleated cells from your own bone marrow, injected or infused into an ischemic limb, will restore sufficient blood flow to avoid amputation.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | centrifuge, laboratory, tabletop (SmartPReP2 BMAC System) | autologous bone marrow aspirate will be concentrated using the SmartPRep2 BMAC system and then injected/infused into ischemic limbs |
Timeline
- Start date
- 2007-12-01
- Primary completion
- 2009-10-01
- Completion
- 2010-04-01
- First posted
- 2008-01-16
- Last updated
- 2012-03-09
Locations
1 site across 1 country: India
Source: ClinicalTrials.gov record NCT00595257. Inclusion in this directory is not an endorsement.