Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||35 Years - 75 Years|
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Eugene Y Roh, MDJason Dragoo, MD|
|Principal Investigator Affiliation||Stanford UniversityStanford University|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
The disease, disorder, syndrome, illness, or injury that is being studied.
|Osteoarthritis, Knee, Knee Pain|
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.
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.
Active Comparator: Conventional therapy
Intra-articular injection of corticosteroid (Triamcinolone 40mg).
Procedure: - Stem Cell injection
Harvesting of adipose-derived stem cells with intra-articular injection
Procedure: - Corticosteroid injection
Sham harvesting of adipose tissue without intra-articular injection. Intra-articular injection of corticosteroid.
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.