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

NCT00885729 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2015-10-15

No results posted yet for this study

Summary

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).

Conditions

  • Defect of Articular Cartilage

Interventions

PROCEDURE

stem cells

Stem cells or chondrocytes under a commercial available membrane

PROCEDURE

Chondrocytes

Implantation of chondrocytes

OTHER

Rehabilitation program

Strength exercises, neuromuscular exercises

Sponsors & Collaborators

  • University Hospital, Akershus

    lead OTHER

Principal Investigators

  • Lars Engebretsen, MD,PhD · Professor

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
50 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2009-04-30
Primary Completion
2011-07-31
Completion
2018-07-31

Countries

  • Norway

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00885729 on ClinicalTrials.gov