Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee
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|ClinicalTrials.gov Identifier: NCT02958267|
Recruitment Status : Completed
First Posted : November 8, 2016
Results First Posted : September 24, 2019
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Knee Osteoarthritis||Biological: BMAC injection Biological: PRP injection Device: Gel-One® hyaluronate injection||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||32 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Investigation of Mesenchymal Stem Cell Therapy for the Treatment of Osteoarthritis of the Knee: Effect on Pain and Quality of Life|
|Study Start Date :||December 2016|
|Actual Primary Completion Date :||August 2018|
|Actual Study Completion Date :||August 2018|
Experimental: BMAC injection and PRP injection
Injection of bone marrow aspirate concentrate (BMAC) withdrawn from a bone near the hip into the knee joint (intra-articular) immediately followed by an injection of platelet-rich plasma (PRP) into the knee joint.
Biological: BMAC injection
60mL of bone marrow will be collected from a bone near the hip. Approximately 5-6mL of the bone marrow aspirate concentrate is then used for injection, under ultrasound guidance, into the target knee by the study physician.
Biological: PRP injection
60mL of venous blood will be withdrawn from either arm. Approximately 4-5 ml of platelet-rich plasma will be introduced under ultrasound guidance to the subject's target knee by the study physician.
Active Comparator: Gel-One® hyaluronate injection
Gel-One® is an hyaluronate gel used in the treatment of knee osteoarthritis by injection into the knee joint (intra-articular).
Device: Gel-One® hyaluronate injection
Patients will receive a single injection of Gel-One® (3 ml syringe of Gel-One® - 1% solution [10 mg/mL], 30mg total hyaluronan) into the target knee. Injections will be performed by the study physician under real-time dynamic ultrasound guidance.
- Knee Injury and Osteoarthritis Outcome Score [ Time Frame: Change from baseline to 3, 6, and 12 months post-treatment ]Subscales include pain, symptoms, function in activities of daily living, function in sport and recreation, and knee-related quality of life. Each subscale is 0-100 with 100 indicating the best possible score.
- Numeric Pain Rating Scale [ Time Frame: Change from baseline to 3, 6, and 12 months post-treatment ]Scale from 0-10 with 0 representing "no pain" and 10 representing "worst imaginable pain"
- Patient Reported Outcome Measurement Information System Global Health Scores [ Time Frame: Change from baseline to 3, 6, and 12 months post-treatment ]The Patient Reported Outcomes Measurement Information System (PROMIS®) Global Health scale v1.1 contains 10 questions and produces two subscale scores: Global Physical Health (GPH) and Global Mental Health (GMH) (Hays, Bjorner, Revicki, Spritzer, & Cella, 2009). Each subscale produces a raw score that is converted to a T score such that an average patient in the United States would have a subscale T score of 50 with a standard deviation of 10 points ("Global Health: A Brief Guide to the PROMIS® Global Health Instruments", 2017). A score higher than the mean indicates a more desirable score, and vice versa. A positive change score indicates an improvement, while a negative change score indicates a decline in score value.
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): NCT02958267
|United States, Ohio|
|McConnell Spine, Sport, and Joint Physicians|
|Columbus, Ohio, United States, 43214|
|Principal Investigator:||Joseph J Ruane, DO||Medical Director, McConnell Heart Health Center|