Autologous Adipose-Derived Stromal Vascular Fraction Cells for Osteoarthritis Treatment
Condition: Osteoarthritis; Joint Disease; Osteoarthritis,Knee; Arthritis, Degenerative; Osteoarthrosis; Osteoarthrosis Deformans
MeSH terms: Osteoarthritis; Osteoarthritis, Knee; Joint Diseases
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Intra-articular auto-SVFs injection; Hyaluronic Acid
Intervention type(s): Procedure; Drug
Intervention description(s): Liposuction under local anesthesia followed by single intra-articular injection of auto-SVFs under the ultrasound navigation; Single intra-articular injection of Synocrom Forte 2% under the ultrasound navigation
Other intervention name(s): Synocrom Forte
Intervention MeSH terms: Hyaluronic Acid
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Adipose -Derived Stromal Vascular Fraction Cells; Knee Osteoarthritis; Intra-articular Administration; Liposuction