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| Name | Class |
|---|---|
| University of Southern California | OTHER |
| Midwest Orthopedics at Rush - Chicago, IL | UNKNOWN |
| Unlimited Research - San Antonio, TX | UNKNOWN |
| Triangle Orthopaedic Associates, P.A. |
The purpose of this study is to determine whether Chondrogen is a safe and effective post-operative treatment of the knee following menisectomy (the surgical removal of all or part of a torn meniscus).
Chondrogen is a preparation of adult mesenchymal stem cells (MSCs) in a solution containing hyaluronic acid. Preclinical studies have shown that injection of Chondrogen aids in the repair of meniscal tissue following meniscectomy. In Chondrogen treated subjects, surgically removed meniscal tissue was regenerated, cartilage surface was protected, and joint damage was decreased in comparison to control subjects. These benefits persisted at least one year.
Three groups of recent meniscectomy patients will be followed in this study, including patients that will receive placebo and patients that will be treated with one of two possible doses of Chondrogen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Chondrogen - dose 1 | Active Comparator | Chondrogen - 50 million cells |
|
| Chondrogen - dose 2 | Active Comparator | Chondrogen - 150 million cells |
|
| Vehicle Control | Other | Vehicle Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Mesenchymal Stem Cells | Drug |
| ||
| Hyaluronan |
| Measure | Description | Time Frame |
|---|---|---|
| Meniscal Volume | Changes in meniscal volume over the course of the study as determined by MRI | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Life Questionnaire | Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score). | 2 years |
| Visual Analog Scale (VAS) | Patient perception of pain will be documented using a single VAS pain scale. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Williams, Ph.D. | Osiris Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Southern California | Los Angeles | California | 90033 | United States | ||
| Orthopedic Center of Vero Beach |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 10102814 | Background | Pittenger MF, Mackay AM, Beck SC, Jaiswal RK, Douglas R, Mosca JD, Moorman MA, Simonetti DW, Craig S, Marshak DR. Multilineage potential of adult human mesenchymal stem cells. Science. 1999 Apr 2;284(5411):143-7. doi: 10.1126/science.284.5411.143. | |
| 14673997 | Background | Murphy JM, Fink DJ, Hunziker EB, Barry FP. Stem cell therapy in a caprine model of osteoarthritis. Arthritis Rheum. 2003 Dec;48(12):3464-74. doi: 10.1002/art.11365. |
| Label | URL |
|---|---|
| Osiris Therapeutics, Inc. Home Page | View source |
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| OTHER |
| Orthopedic Center of Vero Beach - Vero Beach, FL | UNKNOWN |
| OrthoIndy | OTHER |
| TRIA Orthopaedic Center | OTHER |
| Greater Chesapeake Orthopaedic Associates, LLC | OTHER |
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| Drug |
|
| Baseline to 2 years |
| Lysholm Knee Scale | Lysholm knee score will be determined according to the questionnaire | 2 years |
| Safety Assessment Adverse Event | Number of participants with Adverse Events. | 2 years |
| Safety Assessment Immunological | Number of participants with clinically significant abnormalities in immunological measures | 2 years |
| Safety Assessment Laboratory | Number of participants with clinically significant abnormalities in laboratory assessments | 2 years |
| Safety Assessment Physical Exam | Number of participants with clinically significant abnormalities in physical examinations. | 2 years |
| Safety Assessment Magnetic Resonance Imaging (MRI) | Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI). | 2 years |
| Vero Beach |
| Florida |
| 32960 |
| United States |
| Midwest Orthopaedics at Rush | Chicago | Illinois | 60612 | United States |
| Ortholndy | Indianapolis | Indiana | 46237 | United States |
| Greater Chesapeake Associates | Baltimore | Maryland | 21218 | United States |
| TRIA Orthopaedic Center | Bloomington | Minnesota | 55431 | United States |
| Triangle Orthopaedics Associates, P.A. | Durham | North Carolina | 27704 | United States |
| Unlimited Research | San Antonio | Texas | 78233 | United States |
| 24430407 | Derived | Vangsness CT Jr, Farr J 2nd, Boyd J, Dellaero DT, Mills CR, LeRoux-Williams M. Adult human mesenchymal stem cells delivered via intra-articular injection to the knee following partial medial meniscectomy: a randomized, double-blind, controlled study. J Bone Joint Surg Am. 2014 Jan 15;96(2):90-8. doi: 10.2106/JBJS.M.00058. |
| ID | Term |
|---|---|
| D006820 | Hyaluronic Acid |
| ID | Term |
|---|---|
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |
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