Novartis Pharmaceuticals is sponsoring a clinical research trial for males and females, ages 18-55 years, with a cartilage injury of partial thickness of one knee.
To learn more about knee joint cartilage injuries, click here.
This study is designed to assess the efficacy, safety, and tolerability of multiple injections of the study drug (or placebo) over 4-weeks into the affected knee joint in regenerating the knee joint cartilage surface in patients with cartilage injuries to the knee. The study will last a total of 28 weeks.
If you are eligible and agree to participate in this study, you will be given either the study drug or a placebo (an inactive drug used to compare its effects to the effects of the tested drug) for four weeks, and afterward, examined three times over the course of 24 weeks. Following the completion of your dosing, these examination visits will take place at 4 weeks, 12 weeks, and 24 weeks after dosing.
Patients who participate in this trial must meet the following requirements:
- Must be between the ages of 18-55 years old
- Must have a cartilage injury of the knee
- Must have symptomatic (pain, impairment), single, partial thickness knee joint cartilage defect of one knee, as shown by MRI or arthroscopy performed within nine months before screening visit
- Must have an onset of pain and impairment of function between two months and two years before screening
Patients who are eligible and decide to enroll in this trial:
- Will receive the study drug four times by injection into the knee joint at seven-day intervals (once a week for four weeks)
- Will receive scheduled telephone calls approximately 48-72 hours after each study drug administration
- Will receive an additional scheduled telephone call two weeks after their last injection
- Will be asked to return to the study site for a follow-up visit at 4, 12, and 24 weeks after their last injection
- Will not be charged to participate
- May receive compensation for time and travel costs
- May withdraw from the trial at any time, for any reason
To learn more about knee joint cartilage injuries, click here.
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