Stem Cell and Growth Factor Injury and Arthritis Clinical Research Study-U.S. California

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The investigators believe that amniotic tissue allografts may be an effective modality to treat osteoarthritis (OA) of the knee. One important mechanism of action may be stimulation of the synovial cells to increase production of endogenous hyaluronic acid (HA). A second mechanism may be the increase in the anabolic factors and a decrease in degenerative factors in the joint. The Investigators propose to quantify the concentration of HA and selected anabolic and degradative factors in synovial fluid aspirate pre and post implantation. While the treatment provided is designed to provide pain relief for symptoms, the purpose of this study is to learn more information about the impact of amniotic tissue allografts on inflammatory markers and growth factors in the knee joint.

Study Type: Interventional  (Clinical Trial)
Estimated Enrollment: 88 participants
Allocation:Randomized
Intervention Model:Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Short-Term Changes in Knee Synovial Fluid Composition Following Intraarticular Implantation of Amniotic Tissue Allograft
Actual Study Start Date: January 4, 2018
Estimated Primary Completion Date: December 2018
Estimated Study Completion Date: December 2018

Contacts

Susan Hennessy, PhD415-921-1220research@stoneresearch.org

Locations

United States, California
Stone Research FoundationRecruiting
San Francisco, California, United States, 94123
ClinicalTrials.gov Identifier: NCT03408145  

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