Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects
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|ClinicalTrials.gov Identifier: NCT00885729|
Recruitment Status : Active, not recruiting
First Posted : April 22, 2009
Last Update Posted : October 15, 2015
The purpose of this study is to:
- Compare the treatment efficacy of autologous mesenchymal stem cells (Mesenchymal Stem Cells) versus chondrocytes implanted in a commercial available scaffold in a human clinical trial.
- Determine the effects of specific three months strength training program preoperatively to improve knee function and possible postpone the need of cartilage repair surgery.
- Determine if degenerative changes occur in the knee joints following cartilage repair. This question will be investigated in the proposed clinical trial.
- Determine the characteristics of patients treated either by surgery or by rehabilitation in a long-term follow-up (1, 5 years).
|Condition or disease||Intervention/treatment||Phase|
|Defect of Articular Cartilage||Procedure: stem cells Procedure: Chondrocytes Other: Rehabilitation program||Phase 1|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||50 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Mesenchymal Stem Cells in a Clinical Trial to Heal Articular Cartilage Defects|
|Study Start Date :||April 2009|
|Primary Completion Date :||July 2011|
|Estimated Study Completion Date :||July 2018|
Experimental: Stem cells
Cartilage defect are treated surgical either with chondrocytes or stem cells
Procedure: stem cells
Stem cells or chondrocytes under a commercial available membraneProcedure: Chondrocytes
Implantation of chondrocytes
Active Comparator: Rehabilitation
Active rehabilitation program
Other: Rehabilitation program
Strength exercises, neuromuscular exercises
- Lysholm score [ Time Frame: 2018 ]
- Radiographics [ Time Frame: Two and five years ]
- Return to work [ Time Frame: 1 Year ]Return to work one year after surgery
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00885729
|Oslo, Norway, 0481|
|Study Chair:||Lars Engebretsen, MD,PhD||Professor|