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

Study Overview
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Brief Summary
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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.

Detailed Description
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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. 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.

Official Title
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Safety and Effectiveness of Autologous Regenerative Cell Therapy on Pain and Inflammation Associated With Osteoarthritis of the Knee

Conditions
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Osteoarthritis

Intervention / Treatment
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* Biological: [StroMed + platelet rich plasma (PRP)]
* Biological: [PRP] platelet rich plasma
* Biological: [PRP] platelet rich plasma


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration or chronic injury. Patients range from 18-90 years of age. Patients must be able to comply with treatment plan, laboratory tests and periodic interviews. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl. Patients with adequate cardiac and respiratory function. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT Patients must have adequate immune system function, with no known immunodeficiency disease. Greater than 6 months knee pain on the index side (left or right knee). 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: Knee instability. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or complex surgery. Gout or pseudo gout Treatments with strong opioid drugs in the previous 4 weeks for other pain rather than knee osteoarthritis Corticosteroid injection at treatment site within 1 month Consistent use of NSAIDs within 48 hours of procedure.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cohort 1<br>Interventions assigned by Principal Investigator | Biological: [StroMed + platelet rich plasma (PRP)]<br>* [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.<br>Biological: [PRP] platelet rich plasma<br>* 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<br>|
| Experimental: Cohort 2<br>Interventions assigned by Principal Investigator | Biological: [StroMed + platelet rich plasma (PRP)]<br>* [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.<br>Biological: [PRP] platelet rich plasma<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed for the KOOS survey (Knee Osteoarthritis Outcome Score) | Knee osteoarthritis outcome score | 0, 2, 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change is being assessed by MRI of afflicted joint | Looking for cartilage regrowth via MRI | 0 and (6 - 12 months optional) | 
| Change is being assessed for the SF36 survey (Short Form Health Survey) | Short Form health Survey | 0,2,6 months | 
| Change is being assessed for the NRS survey (Numerical Rating Scale for Pain) | Numerical Rating Scale for pain | 0,2,6 months |