The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
The Effects of Stromal Vascular Fraction and Mesenchymal Stem Cells as Intra-articular Injection in Knee Joint Osteoarthritis
Osteoarthritis of the knee is one of the most common causes of disability among elderly. As
 the disease progresses the cartilage become frustrated, surrounding bone react to become
 thicker and inflammation occurs in subchondral bone seen in T2-weighted MRI as increase in
 signal density. Patients are treated initially by pain management. In patients who don't
 response to first line treatment invasive treatment like total knee replacement is done. The
 investigators designed this clinical study with the aim of evaluating therapeutic effects of
 intra-articular injection of bone marrow Mesenchymal Stem Cells (MSC) and stromal Vascular
 Fraction (SVF) in patients with severe knee osteoarthritis
This is single center, randomized, triple blind phase II clinical study. Patients will be
 divided into two groups of case and control. All subjects will undergo bone marrow
 aspiration. Mesenchymal Stem Cells will be isolated from bone marrow and stromal Vascular
 Fraction fram lipoaspirate, cultured and transplanted back to the knee joint. Patients of
 case group will receive cell injection 1 and 4 months after bone marrow aspiration. Placebo
 will be administered in this group 6 months after the first injection. Patients of control
 group will receive placebo 1 and 4 months after bone marrow aspiration. They all receive cell
 injection 6 months after first placebo injection. Follow up visit will occur at 2 and 6
 weeks, and 3 and 6 months after the first injection. Radiological exams will be performed
 before and 6 months after the first injection by MRI. Clinical quantitative assessment will
 measure joint function by the WOMAC index and pain by the visual analogue scale
Inclusion Criteria:

 -  Osteoarthritis diagnosed by MRI

 Exclusion Criteria:

 -  Pregnancy or lactating

 -  Positive tests for HIV, Hepatitis C virus (HCV), Hepatitis C virus (HBV)

 -  Active neurologic disorder

 -  End organ damage

 -  Uncontrolled endocrine disorder