A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
NCT ID: NCT00225095
Last Updated: 2021-12-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2005-09-30
2008-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Chondrogen - dose 1
Chondrogen - 50 million cells
Mesenchymal Stem Cells
Chondrogen - dose 2
Chondrogen - 150 million cells
Mesenchymal Stem Cells
Vehicle Control
Vehicle Control
Hyaluronan
Interventions
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Mesenchymal Stem Cells
Hyaluronan
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
60 Years
ALL
No
Sponsors
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University of Southern California
OTHER
Midwest Orthopedics at Rush - Chicago, IL
UNKNOWN
Unlimited Research - San Antonio, TX
UNKNOWN
Triangle Orthopaedic Associates, P.A.
OTHER
Orthopedic Center of Vero Beach - Vero Beach, FL
UNKNOWN
OrthoIndy
OTHER
TRIA Orthopaedic Center
OTHER
Greater Chesapeake Orthopaedic Associates, LLC
OTHER
Mesoblast International Sàrl
INDUSTRY
Responsible Party
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Principal Investigators
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Michelle Williams, Ph.D.
Role: STUDY_DIRECTOR
Osiris Therapeutics, Inc.
Locations
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University of Southern California
Los Angeles, California, United States
Orthopedic Center of Vero Beach
Vero Beach, Florida, United States
Midwest Orthopaedics at Rush
Chicago, Illinois, United States
Ortholndy
Indianapolis, Indiana, United States
Greater Chesapeake Associates
Baltimore, Maryland, United States
TRIA Orthopaedic Center
Bloomington, Minnesota, United States
Triangle Orthopaedics Associates, P.A.
Durham, North Carolina, United States
Unlimited Research
San Antonio, Texas, United States
Countries
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References
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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.
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.
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.
Related Links
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Osiris Therapeutics, Inc. Home Page
Other Identifiers
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Osiris 550
Identifier Type: -
Identifier Source: org_study_id