Adipose-Derived Stem Cell Injections for Knee Osteoarthritis
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|ClinicalTrials.gov Identifier: NCT03467919|
Recruitment Status : Recruiting
First Posted : March 16, 2018
Last Update Posted : August 6, 2018
|Condition or disease||Intervention/treatment||Phase|
|Osteoarthritis, Knee Knee Pain||Procedure: Stem Cell injection Drug: Corticosteroid injection||Phase 3|
This study will be a randomized controlled trial to compare outcomes between intra-articular injection of ADSC+PRP 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.
PRP is prepped from the peripheral blood. Up to 30 ml of peripheral blood is drawn from the peripheral blood vessel then it is transferred to the tube for centrifugation to yield a platelet-rich plasma layer. This process is expected to take up to 1 hour.
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 :||45 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||The Effect of Adipose-Derived Stem Cell With Platelet-Rich Plasma Injections on Knee Osteoarthritis|
|Actual Study Start Date :||April 1, 2018|
|Estimated Primary Completion Date :||June 2019|
|Estimated Study Completion Date :||June 2020|
Experimental: Stem Cells (with PRP)
Intra-articular knee injection of autologous Adipose-Derived Mesenchymal Stem Cells (ADSC) harvested from the thigh using tumescent liposuction and processing with syringe emulsification and cell concentration using Harvest Adiprep System. This harvested tissue will then be combined with leukocyte poor-platelet-rich plasma (PRP) processed using the Harvest PRP system and then injected into the patient's knee.
Procedure: Stem Cell injection
Harvesting of adipose-derived stem cells and platelet-rich plasma with intra-articular injection
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg)
Drug: Corticosteroid injection
Sham harvesting of adipose tissue and peripheral blood 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: Michelle Backer, BS||(650) email@example.com|
|United States, California|
|Stanford, California, United States, 94305|
|Contact: Jason L Dragoo, MD firstname.lastname@example.org|
|Principal Investigator: Jason L Dragoo, MD|
|Principal Investigator: Eugene Y Roh, MD|
|Sub-Investigator: Adrian DK Le, MD|
|Principal Investigator:||Jason L Dragoo, MD||Stanford University|
|Principal Investigator:||Eugene Y Roh, MD||Stanford University|
|Study Director:||Adrian DK Le, MD||Stanford University|