A Phase I/II Study of Chondrogen Delivered by Intra-Articular Injection Following Meniscectomy
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|ClinicalTrials.gov Identifier: NCT00225095|
Recruitment Status : Completed
First Posted : September 23, 2005
Last Update Posted : October 26, 2020
|Condition or disease||Intervention/treatment||Phase|
|Recovery Following Partial Medial Meniscectomy||Drug: Mesenchymal Stem Cells Drug: Hyaluronan||Phase 1 Phase 2|
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 Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||60 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||A Phase I/II, Randomized, Controlled, Double Blind, Study of Chondrogen - Adult Universal Cell Delivered by Intra-Articular Injection Following Meniscectomy in Patients 18-60 Years|
|Study Start Date :||September 2005|
|Actual Primary Completion Date :||April 2008|
|Actual Study Completion Date :||April 2008|
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
- Meniscal Volume [ Time Frame: 6 months ]Changes in meniscal volume over the course of the study as determined by MRI
- Quality of Life Questionnaire [ Time Frame: 2 years ]Determination of Quality of Life will be measured by the KOOS instrument (Knee injury and Osteoarthritis Outcome Score).
- Visual Analog Scale (VAS) [ Time Frame: Baseline to 2 years ]Patient perception of pain will be documented using a single VAS pain scale.
- Lysholm Knee Scale [ Time Frame: 2 years ]Lysholm knee score will be determined according to the questionnaire
- Safety Assessment Adverse Event [ Time Frame: 2 years ]Number of participants with Adverse Events.
- Safety Assessment Immunological [ Time Frame: 2 years ]Number of participants with clinically significant abnormalities in immunological measures
- Safety Assessment Laboratory [ Time Frame: 2 years ]Number of participants with clinically significant abnormalities in laboratory assessments
- Safety Assessment Physical Exam [ Time Frame: 2 years ]Number of participants with clinically significant abnormalities in physical examinations.
- Safety Assessment Magnetic Resonance Imaging (MRI) [ Time Frame: 2 years ]Number of participants with clinically significant abnormalities in Magnetic Resonance Imaging (MRI).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00225095
|United States, California|
|University of Southern California|
|Los Angeles, California, United States, 90033|
|United States, Florida|
|Orthopedic Center of Vero Beach|
|Vero Beach, Florida, United States, 32960|
|United States, Illinois|
|Midwest Orthopaedics at Rush|
|Chicago, Illinois, United States, 60612|
|United States, Indiana|
|Indianapolis, Indiana, United States, 46237|
|United States, Maryland|
|Greater Chesapeake Associates|
|Baltimore, Maryland, United States, 21218|
|United States, Minnesota|
|TRIA Orthopaedic Center|
|Bloomington, Minnesota, United States, 55431|
|United States, North Carolina|
|Triangle Orthopaedics Associates, P.A.|
|Durham, North Carolina, United States, 27704|
|United States, Texas|
|San Antonio, Texas, United States, 78233|
|Study Director:||Michelle Williams, Ph.D.||Osiris Therapeutics, Inc.|