Status:
COMPLETED
Phase 2a Study on Allogeneic Osteoblastic Cells Implantation in Lumbar Spinal Fusion
Lead Sponsor:
Bone Therapeutics S.A
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
Among existing surgical techniques, spinal fusion is considered as the gold standard to treat a broad spectrum of degenerative spine disorders, including spondylolisthesis and scoliosis, with regard t...
Eligibility Criteria
Inclusion
- Ability to provide a written, dated, and signed informed consent prior to any study related procedure, and to understand and comply with study requirements
- Symptomatic degenerative disc disease of the lumbar spine requiring a single level lumbar fusion (L1-S1)
- Unresponsive to non-operative treatment for at least 6 months
Exclusion
- Lumbar disc disease requiring treatment at more than one level
- Previous failed fusion at the involved lumbar level
- Local active or latent infection at the involved lumbar level
- Positive serology for hepatitis B, hepatitis C, HIV
- Current or past medical disease that could interfere with the evaluation of the safety and efficacy, as judged by the investigator
Key Trial Info
Start Date :
October 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 25 2021
Estimated Enrollment :
38 Patients enrolled
Trial Details
Trial ID
NCT02205138
Start Date
October 1 2014
End Date
January 25 2021
Last Update
January 29 2021
Active Locations (8)
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1
Investigating site BE01
Brussels, Belgium
2
Investigating site BE03
Brussels, Belgium
3
Investigating site BE05
Brussels, Belgium
4
Investigating site BE02
Charleroi, Belgium