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RECRUITING
NCT02844751
PHASE2

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

Sponsor: VivaTech International, Inc.

View on ClinicalTrials.gov

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

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