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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.
Full description
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.
Enrollment
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Inclusion criteria
Exclusion criteria
Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell or squamous cell cancer resolved by excision
Presence of clinically significant acute or unstable cardiovascular and cerebrovascular (stroke).
Diagnosis of a transient ischemic attack in the 6 months prior to screening.
Patients infected with hepatitis B, C or HIV.
Patients with Body Mass Index (BMI) > 40kg/m2
Presence of active infection.
Any other illness, psychiatric disorder, alcohol or chemical dependence that in the opinion of the investigator would render a patient unsuitable to participate in the study.
Conditions/therapies/factors which could confound or interfere with the evaluation of pain/mobility including, but not limited to:
Primary purpose
Allocation
Interventional model
Masking
4,000 participants in 2 patient groups
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Central trial contact
Scott M Herkes, MBA; Michael P Hutchinson, DVM
Data sourced from clinicaltrials.gov
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