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Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
Sponsor: VivaTech International, Inc.
Summary
This is a prospective open-label clinical study of 50 patients to determine safety and treatment potential of autologous cell therapy for pain and inflammation associated with Osteoarthritis of the knee. Follow-up will consist of a larger sample including 4,000 patients.
Official title: Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee
Key Details
Gender
All
Age Range
18 Years - 90 Years
Study Type
INTERVENTIONAL
Enrollment
4000
Start Date
2015-07
Completion Date
2026-08
Last Updated
2025-10-14
Healthy Volunteers
Yes
Conditions
Interventions
[StroMed + platelet rich plasma (PRP)]
\[Day 0\] - Because no enzymes or drugs are added with this mechanical process, the resulting cell concentrate still contains the extra-cellular matrix. In addition, the cells have not been altered by manipulation with enzymes or culturing. This autologous, cell concentrate is of minimal risk to the patient with no artificial ingredients added. Also Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint.
[PRP] platelet rich plasma
Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 7,14 and 30
[PRP] platelet rich plasma
Additional treatments with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product and by direct injection to the affected joint. Days 30 and 60
Locations (1)
VivaTech International, Inc.
Grove City, Pennsylvania, United States