RecruitingPhase 2NCT02844751

Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee

Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee


Sponsor

VivaTech International, Inc.

Enrollment

4,000 participants

Start Date

Jul 1, 2015

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called [PRP] platelet rich plasma, a biological treatment called [PRP] platelet rich plasma, and others for people with osteoarthritis. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 90 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BIOLOGICAL[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.

BIOLOGICAL[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

BIOLOGICAL[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

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NCT02844751


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