Moderate intervertebral disc degeneration without radiculopathy MedDRA version: 14.1 Level: LLT Classification code 10025020 Term: Lumbosacral spondylosis without myelopathy System Organ Class: 100000004859
Conditions
Interventions
Product Name: Mesenchymal stromal cells
Product Code: Mesenchymal stromal cells
Pharmaceutical Form: Injection
Sponsors
Orthopaedic Research Laboratory, Århus University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Low back pain without radiculopathy Moderate disc degeneration (Pfirrmann Grdae 2-3) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 34 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: Disc herniation Spondylolisthesis (Grade 2 or more)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To improve low back pain and disc hydration;Secondary Objective: To improve disc nutrition by diffusion Improve bone morphogenesis in surrounding vertebrae;Primary end point(s): Oswestry Disability Index SF-36 Dallas Pain Questionaire MRI;Timepoint(s) of evaluation of this end point: 6 weeks 12 weeks 24 weeks 1 year 2 years | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Diffusion into the disc Bone morphogenesis of vertebrae;Timepoint(s) of evaluation of this end point: 6 weeks 12 weeks 24 weeks 1 year 2 years | — |
Countries
Denmark
Contacts
Public ContactOrthopaedic Research Laboratory
Århus University Hospital
Outcome results
None listed