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.
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. Patients will be treated for Osteoarthritis (OA) of the shoulder 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 the RegenLab (RegenKit BCT-3) PRP product each as direct injections to the affected joints. Patient outcomes will be tracked with laboratory tests for inflammation markers, the DASH and SPADI questionnaires and a follow up MRI at various endpoints to 6 months. SF-36 forms (a quality of life measure) and numerical ratings 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 shoulder planning/replacement therapy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
4,000
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 \[PRP\]
VivaTech International, Inc.
Grove City, Pennsylvania, United States
RECRUITINGChange is being assessed for the DASH Survey (Disabilities of the Arm, Shoulder, Hand
Disabilities of the Arm, Shoulder, and Hand
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 months optional)
Change is being assessed for the SPADI Survey (Shoulder Pain and Disability Index)
Shoulder Pain and Disability Index
Time frame: 0,2,6 Months
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
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