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XCEL-MT-OSTEO-ALPHA for Spinal Fusion in Degenerative Spine Disease
NCT01552707Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2012
- Primary completion
- May 2018
- Countries
- 1
- Sponsor
- Banc de Sang i Teixits
- Modality
- Implantable Devices, Implantable Hydrogels, Cell Therapies
- Drugs
- XCEL-MT-OSTEO-ALPHA
- Conditions
- lumbar spondylolisthesisintervertebral disc degeneration (DDD)
01
Overview
Phase 2, randomised, open-label trial of XCEL-MT-OSTEO-ALPHA in lumbar spondylolisthesis and intervertebral disc degeneration (DDD), sponsored by Banc de Sang i Teixits. Primary endpoint: Safety of XCEL-MT-OSTEO-ALPHA at 12 months. Started Jul 2012; status: completed.
02
Design
- Study design
- RandomizedOpen-label
03
Who it enrols
Adults aged 18-85 with L4-L5 degenerative spondylolisthesis or discopathy, excluding those with previous spine surgery, smokers (>10 cigarettes/day), or active infections.
04
Endpoints
Primary
Safety of XCEL-MT-OSTEO-ALPHA
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