A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
Study Details
Study Description
Brief Summary
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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1/Phase 2 |
Detailed Description
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Chondrogen - dose 1 Chondrogen - 50 million cells |
Drug: Mesenchymal Stem Cells
|
| Active Comparator: Chondrogen - dose 2 Chondrogen - 150 million cells |
Drug: Mesenchymal Stem Cells
|
| Other: Vehicle Control Vehicle Control |
Drug: Hyaluronan
|
Outcome Measures
Primary Outcome Measures
- Meniscal Volume [6 months]
Changes in meniscal volume over the course of the study as determined by MRI
Secondary Outcome Measures
- Quality of Life Questionnaire [2 years]
Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).
- Visual Analog Scale (VAS) [Baseline to 2 years]
Patient perception of pain will be documented using a single VAS pain scale.
- Lysholm Knee Scale [2 years]
Lysholm knee score will be determined according to the questionnaire
- Safety Assessment Adverse Event [2 years]
Number of participants with Adverse Events.
- Safety Assessment Immunological [2 years]
Number of participants with clinically significant abnormalities in immunological measures
- Safety Assessment Laboratory [2 years]
Number of participants with clinically significant abnormalities in laboratory assessments
- Safety Assessment Physical Exam [2 years]
Number of participants with clinically significant abnormalities in physical examinations.
- Safety Assessment Magnetic Resonance Imaging (MRI) [2 years]
Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Age 18 to 60, inclusive
-
In need of medial meniscectomy
-
Normal axial alignment
-
Stable knee- previous ligament reconstruction, if stable
-
Removal of at least 50% of the affected portion of the medial meniscus
-
Intact articular cartilage in posterior meniscal weight-bearing zone
-
Willingness to follow normal post-operative rehabilitation
-
Willingness to participate in follow-up for two years from the time of meniscectomy surgery
-
Ability to understand and willingness to sign consent form
Exclusion Criteria:
-
Pregnant or lactating
-
ACL or other support structure damage confirmed at surgery
-
Grade III or IV cartilage damage (Cartilage loss greater than 50% thickness in area
15mm on weight-bearing aspect of femoral condyle or tibial plateau)
-
Synvisc, steroid, or corticosteroid injections in preceding 3 months
-
Diffuse synovitis at time of arthroscopy
-
Inflammatory arthritis
-
Oral steroid, methotrexate therapy
-
Unable to follow post-operative exercise regimen or return for evaluations
-
Active alcohol or substance abuse within 6 months of study entry
-
Current and active tobacco product use
-
Patient is positive for HIV
-
Patient is positive for hepatitis (past history of Hepatitis A is allowed)
-
Any medical condition, which in the opinion of the clinical investigator, would interfere with the treatment or outcome of the patient
-
Indwelling pacemaker
-
Cerebral aneurysm clips
-
Ear, eye and penile implants with avian components
-
Electrical indwelling device such as bone stimulator
-
Indwelling magnets as tissue expander for future implants
-
Known allergy to avian, bovine or porcine protein
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | University of Southern California | Los Angeles | California | United States | 90033 |
| 2 | Orthopedic Center of Vero Beach | Vero Beach | Florida | United States | 32960 |
| 3 | Midwest Orthopaedics at Rush | Chicago | Illinois | United States | 60612 |
| 4 | Ortholndy | Indianapolis | Indiana | United States | 46237 |
| 5 | Greater Chesapeake Associates | Baltimore | Maryland | United States | 21218 |
| 6 | TRIA Orthopaedic Center | Bloomington | Minnesota | United States | 55431 |
| 7 | Triangle Orthopaedics Associates, P.A. | Durham | North Carolina | United States | 27704 |
| 8 | Unlimited Research | San Antonio | Texas | United States | 78233 |
Sponsors and Collaborators
- Mesoblast International Sàrl
- University of Southern California
- Midwest Orthopedics at Rush - Chicago, IL
- Unlimited Research - San Antonio, TX
- Triangle Orthopaedic Associates, P.A.
- Orthopedic Center of Vero Beach - Vero Beach, FL
- OrthoIndy
- TRIA Orthopaedic Center
- Greater Chesapeake Orthopaedic Associates, LLC
Investigators
- Study Director: Michelle Williams, Ph.D., Osiris Therapeutics, Inc.
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- 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.
- 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.
- Osiris 550