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The objective of the study is to determine the safety and tolerability of two different formulations of BMP-7 for the treatment of osteoarthritis of the knee.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Experimental | 0.03 mg/ml BMP-7 or placebo via intraarticular knee injection |
|
| Cohort 2 | Experimental | 0.1 mg/ml BMP-7 or placebo via intraarticular knee injection |
|
| Cohort 3 | Experimental | 0.3 mg/ml BMP-7 or placebo via intraarticular knee injection |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone morphogenetic protein 7 | Drug | Single intraarticular injection of BMP-7 or placebo on Day 1 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety (physical examination, vital signs, clinical laboratory measurements, adverse events) | Baseline, Day 2, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| WOMAC pain and function | Baseline, Week 4, Week 8, Week 12, Week 24 | |
| Patient and physician global VAS | Baseline, Week 1, Week 2, Week 4, Week 8, Week 12, Week 24 | |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Florida Medical Research Institute | Gainesville | Florida | 32607 | United States | ||
| Tufts Medical Center |
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| Quality of life measurement (SF-36) and pain medication use |
| Baseline, Week 4, Week 8, Week 12, Week 24 |
| Boston |
| Massachusetts |
| 02111 |
| United States |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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| ID | Term |
|---|---|
| D055419 | Bone Morphogenetic Protein 7 |
| ID | Term |
|---|---|
| D019485 | Bone Morphogenetic Proteins |
| D055411 | TGF-beta Superfamily Proteins |
| D036341 | Intercellular Signaling Peptides and Proteins |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D011506 | Proteins |
| D001685 | Biological Factors |
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