Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
Safety & Effectiveness of Autologous Regenerative Cell Therapy on Pain & Inflammation of Osteoarthritis of the Knee
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.
Inclusion Criteria:

 1. Patients with indication of Osteoarthritis, grade 2 or more. Can be from degeneration
 or chronic injury.

 2. Patients range from 18-90 years of age.

 3. Patients must be able to comply with treatment plan, laboratory tests and periodic
 interviews.

 4. Patients with adequate renal function, Creatinine ≤ 1.5 mg/dl.

 5. Patients with adequate cardiac and respiratory function.

 6. Patients with adequate blood coagulation activity, PT(INR) < 1.5, APTT

 7. Patients must have adequate immune system function, with no known immunodeficiency
 disease.

 8. Greater than 6 months knee pain on the index side (left or right knee).

 Exclusion Criteria:

 1. Neoplastic cancer within 5 years prior to screening, except for cutaneous basal cell
 or squamous cell cancer resolved by excision

 2. Presence of clinically significant acute or unstable cardiovascular and
 cerebrovascular (stroke).

 3. Diagnosis of a transient ischemic attack in the 6 months prior to screening.

 4. Patients infected with hepatitis B, C or HIV.

 5. Patients with Body Mass Index (BMI) > 40kg/m2

 6. Presence of active infection.

 7. 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.

 8. Conditions/therapies/factors which could confound or interfere with the evaluation of
 pain/mobility including, but not limited to:

 1. Knee instability.

 2. A varus/valgus deformity of more than 10o, a deformity requiring osteotomy or
 complex surgery.

 3. Gout or pseudo gout

 4. Treatments with strong opioid drugs in the previous 4 weeks for other pain rather
 than knee osteoarthritis

 5. Corticosteroid injection at treatment site within 1 month

 6. Consistent use of NSAIDs within 48 hours of procedure.