Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects

• Register: ClinicalTrials.gov
• Last refreshed on: 26 October 2015
• Main ID: NCT00885729
• Date of registration: 17/04/2009
• Prospective Registration: No
• Primary sponsor: University Hospital, Akershus
• Public title: Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects
• Scientific title: Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects
• Date of first enrolment: April 2009
• Target sample size: 50
• Recruitment status: Active, not recruiting
• URL: https://clinicaltrials.gov/show/NCT00885729
• Study type: Interventional
• Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
• Phase: Phase 1

Countries of recruitment

Norway

Contacts

• Name: Lars Engebretsen, MD,PhD
• Affiliation: Professor

Key inclusion & exclusion criteria

Inclusion Criteria:

- Norwegian citizens

- A full-thickness cartilage lesion (diameter > 15 mm, but less than 6 cm2 and Lysholm
score < 75 points) located on the femoral condyle

Exclusion Criteria:

- Patients with malignment of the knee

- Other knee pathology such as ACL injury or a nontreated meniscus injury will not be
included in the study to avoid the impact of these knee pathologies on the final
results



Age minimum: 18 Years
Age maximum: 50 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Defect of Articular Cartilage

Intervention(s)

Procedure: Chondrocytes

Other: Rehabilitation program

Procedure: stem cells

Primary Outcome(s)

Lysholm score [Time Frame: 2018]

Secondary Outcome(s)

Radiographics [Time Frame: Two and five years]

Secondary ID(s)

S-0738c 2009

Source(s) of Monetary Support

Please refer to primary and secondary sponsors