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

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.