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Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Shoulder
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 shoulder. 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 Shoulder
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)]
Patients will be treated with autologous StroMed obtained by the Adipose Ultrasonic Cell Recovery Unit and Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints at the time of initial treatment. Thereafter the affected joints will be treated as direct injections to the joint with Platelet Rich Plasma processed by the RegenLab (RegenKit BCT-3) PRP product. Day 0 \[StroMed + platelet rich plasma (PRP)\], Days 7 and 14 \[PRP\]
Locations (1)
VivaTech International, Inc.
Grove City, Pennsylvania, United States