Osteoarthritis Clinical Trial
Official title:
Safety/Efficacy of Intra-articularly Administrated Autologous Adipose -Derived Stromal Vascular Fraction Cells in Treatment of Knee Osteoarthritis
Adipose-derived stromal vascular fraction cells (SVFs) include regenerative cell populations
(hematopoietic cells, pericytes, endothelial cells and progenitors, stromal/stem cells) and
thus are potentially important as new therapeutic tools for the repair and regeneration of
acute and chronically damaged tissues.
The general objective of this study is to evaluate safety and clinical efficacy of a single
intra-articular injection of freshly isolated auto-SVFs for the treatment of patients with
knee osteoarthritis (OA). This study uses autologous adipose-derived SVFs, as therapeutic
agent and intra-articular administration, as a mode of delivery. Expected clinical effects: a
treatment reduces pain, increases function and reduces stiffness in the knees of
osteoarthritic subjects.
Subcutaneous human adipose tissue is an abundant and accessible cell source for applications
in tissue engineering and regenerative medicine. Methods to extract stromal/stem cells from
the waste products of abdominoplasty, cosmetic surgery, and liposuction are now well
developed. Routinely, the adipose tissue is digested with collagenase or related enzymes to
release a heterogeneous population of SVF cells. The SVF cells can be used directly or can be
cultured in plastic ware to select and expand an adherent population known as adipose-derived
stromal/stem cells.
Osteoarthritis is the most common joint disease that affects at least 20% of the world
population. The disease usually begins at the age of 40 years. Radiographic signs of
osteoarthritis are diagnosed in 50% of people aged 55 years and 80% - over 75 years. OA can
cause severe pain and stiffness in the affected joints, thus reducing joint's functionality.
Therefore a treatment that would reduce pain/stiffness and increase joint function would be
of benefit to many people. Safety and feasibility of SVFs in OA patients have been shown in
few clinical studies.
This trial is a prospective, controlled, non-randomized, non-blinded, interventional study to
determine safety and efficacy of a single injection of freshly isolated autologous SVFs into
the knees of osteoarthritic patients (Grade II-III). In experimental group the participants
(n=16) will undergo a standard liposuction to harvest adipose tissue, then the adipose tissue
will be processed to obtain the SVFs and patients will receive a single intra-articular
injection of auto-SVFs into affected knees under the ultrasound navigation. In parallel
control group the participants (n=11) will receive a single intra-articular injection of
hyaluronic acid (Synocrom Forte 2%) under the ultrasound navigation. The safety of auto-SVFs
injection will be evaluated by assessment of the frequency and nature of adverse events
occurring during or immediately after the procedure, and up to the one year following
treatment. Patients will be monitored during 1, 3, 6 and 12- month's visits.
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