Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
Condition(s) studied
Investigational drug(s) / intervention(s)
[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.
[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
[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
Study 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
Primary outcome measure(s)
- Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score) — 0, 2, 6 months
Knee osteoarthritis outcome score
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| VivaTech International, Inc. | Grove City | Pennsylvania | Recruiting |
More VivaTech International, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT02844751 on ClinicalTrials.gov ↗ ← All trials in the USA