RecruitingPhase 2NCT02844738

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

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

Sponsor

VivaTech International, Inc.

Enrollment

4,000 participants

Start Date

Jul 1, 2015

Study Type

INTERVENTIONAL

Conditions

Osteoarthritis

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.

Eligibility

Min Age: 18 YearsMax Age: 90 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a biological treatment called [StroMed + platelet rich plasma (PRP)] 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)]

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 \[PRP\]