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.
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. Patients will be treated for Osteoarthritis (OA) of the knee due to degeneration or chronic injury. They will be treated with autologous Stromed obtained by the Adipose Ultrasonic Cell Recovery Unit (AUCRU) and Platelet Rich Plasma (PRP) processed by RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Cohort 1 will include PRP treatments at time of initial StroMed treatment plus at 1 week, 2 weeks and 1 month. Cohort 2 will include PRP treatments at time of initial StroMed treatment plus at 1 month and 2 months. Patient outcomes will be tracked with a follow up MRI at various endpoints to 6 months, laboratory tests for inflammation markers, and knee injury and osteoarthritis outcome score (KOOS) questionnaires. SF-36 forms (a quality of life measure) and numerical rating scales (NRS) will also be used to assess safety and efficacy of treatment, as well as any reduction in patient medication and/or delay in pending knee replacement therapy.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
4,000
\[Day 0\] - 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.
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
VivaTech International, Inc.
Grove City, Pennsylvania, United States
RECRUITINGChange is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score)
Knee osteoarthritis outcome score
Time frame: 0, 2, 6 months
Change is being assessed by MRI of afflicted joint
Looking for cartilage regrowth via MRI
Time frame: 0 and (6 - 12 months optional)
Change is being assessed for the SF36 survey (Short Form Health Survey)
Short Form health Survey
Time frame: 0,2,6 months
Change is being assessed for the NRS survey (Numerical Rating Scale for Pain)
Numerical Rating Scale for pain
Time frame: 0,2,6 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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