Treatment of arthrosis of the lumbar spine with own stem cells from bonemarrow

Phase 1

• Conditions: Moderate intervertebral disc degeneration without radiculopathy; MedDRA version: 14.1Level: LLTClassification code 10025020Term: Lumbosacral spondylosis without myelopathySystem Organ Class: 100000004859; Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

• Registration Number: EUCTR2012-003160-44-DK
• Lead Sponsor: Orthopaedic Research Laboratory, Århus University Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-01-23
• Last Update Posted: 27 June 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

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

Disc herniation
Spondylolisthesis (Grade 2 or more)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To improve low back pain and disc hydration;Secondary Objective: To improve disc nutrition by diffusion<br>Improve bone morphogenesis in surrounding vertebrae;Primary end point(s): Oswestry Disability Index<br>SF-36<br>Dallas Pain Questionaire<br>MRI;Timepoint(s) of evaluation of this end point: 6 weeks<br>12 weeks<br>24 weeks<br>1 year<br>2 years

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Diffusion into the disc<br>Bone morphogenesis of vertebrae;Timepoint(s) of evaluation of this end point: 6 weeks<br>12 weeks<br>24 weeks<br>1 year<br>2 years