Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03467919|
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : September 24, 2019
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Knee Pain||Procedure: Stem Cell injection Procedure: Corticosteroid injection||Phase 3|
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of ADSC and intra-articular injection of corticosteroid in patients with mild to moderate osteoarthritis of the knee. ADSC will be harvested at the subcutaneous tissue by lipoaspiration. Once fat tissue is obtained, it will be processed with minimal manipulation (Adiprep) in the clinic room.
To be considered for participation in this study, patients must have radiographic evidence of mild to moderate osteoarthritis of medial and/or lateral weight-bearing compartments (Kellgren-Lawrence Grade 2 or 3). In addition, patients must meet several inclusion/exclusion criteria to be randomized and included in this study.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||autologous adipose-derived tissue without culture expansion or enzymatic process will be used.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Adipose-Derived Stem Cell on Knee Osteoarthritis|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||June 2020|
|Estimated Study Completion Date :||June 2020|
Experimental: Stem Cells
Intra-articular knee injection of autologous Adipose-Derived Mesenchymal Stem Cells (ADSC) harvested from the thigh using tumescent lipoaspiration and processing with syringe emulsification and cell concentration using Harvest Adiprep System. This harvested tissue will then be injected into the patient's knee.
Procedure: Stem Cell injection
Harvesting of adipose-derived stem cells with intra-articular injection
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Procedure: Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
- Knee Injury and Osteoarthritis Outcomes Score (KOOS) Score [ Time Frame: 24 months ]Patient reported outcome measure that reports a normalized score (100 indicating no symptoms and 0 indicating extreme symptoms
- Lysholm score [ Time Frame: 24 months ]Patient reported activity outcome measure on a scale of 0-100 (100 is best activity score)
- Veterans RAND 12 (VR-12) score [ Time Frame: 24 months ]Patient reported quality of life outcome measure on a scale of 0-50 with 50 being healthy
- MRI Cartilage Scan [ Time Frame: 24 months ]Cartilage thickness on MRI using T2-weighted cartilage mapping
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): NCT03467919
|Contact: Ma Agnes Ith, MD||(650) email@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Eugene Y Roh, MD 650-721-7600 firstname.lastname@example.org|
|Principal Investigator: Eugene Y Roh, MD|
|Principal Investigator:||Eugene Y Roh, MD||Stanford University|
|Principal Investigator:||Jason Dragoo, MD||Stanford University|