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OsteoarthritisPainBiologicalPhase 2

What this study is

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.

What's being tested

  • [StroMed + platelet rich plasma (PRP)]

    Intervention · BIOLOGICAL

    [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

    Intervention · BIOLOGICAL

    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

    Intervention · BIOLOGICAL

    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

Study details

Official title
Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee
Sponsor
VivaTech International, Inc.
Conditions
Osteoarthritis
Enrolling
4,000 people
Starts
2015-07
Est. completion
2026-08
Design
Open-label, non-randomized, parallel groups, Phase 2
Record
View on ClinicalTrials.gov ↗