The Comparison of Knee Osteoarthritis Treatment With Bone Marrow Aspirate Concentrate , Leukocyte Rich Platelet Rich Plasma and Hyaluronic Acid
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 4

Summary: 
      The aim of this study is to compare therapeutic and clinical effects of intra-articular
      injection of Bone Marrow Aspirate Concentrate (BMAC), inta-articular injection of Leukocyte
      Rich Platelet Rich plasma (LR-PRP) and 3 weekly doses of high molecular weight of Hyaluronic
      acid for the treatment of osteoarthritis (OA) of the knee ( KL scale II-IV).
    

Detailed description: 
      Osteoarthritis (OA) is the most common joint disease worldwide, affecting an estimated 10% of
      men and 18% of women over 60 years of age with the knee and hip joints predominantly
      involved. The pain and loss of function can be debilitating; in developed countries the
      resultant socioeconomic burden is large costing between 1, 0% and 2, 5% of gross domestic
      product. Several therapeutic options for the treatment of OA are widely used, consists of
      pain management, physical therapy with life-modifying recommendations, joint injections with
      joint replacement for end-stage disease. Intra-articular drug delivery has several advantages
      over systemic delivery, including increased local bioavailability, reduced systemic exposure,
      fewer adverse events and reduced cost. Three injectable materials have been widely used for
      intra-articular treatment of the knee OA: corticosteroids (with or without local
      anesthetics), hyaluronic acid based preparations and in the last decade biologic
      preparations, such as human serum albumin, TNF and Il-1 inhibitors, platelet-rich plasma
      (PRP) injections, bone marrow-derived stem cells (BMSCs), adipose-derived stem cells (ADSCs)
      and amnion-derived mesenchymal stem cells (AMSCs) etc PRP is promising therapeutic option for
      the OA treatment, there are still many concerns with PRP's efficiency. Among all questions, (
      Number of platelets, percentage in accordance with baseline, frequency of doses etc.)
      presence or absence of different cells in PRP formulations ( as leukocytes), could
      significantly change an overall clinical result. In general, PRP could be Leukocyte-rich (LR-
      with increase number of Leukocytes in comparison with baseline number) and Leukocyte-poor.

      Another option that has become more popular for physicians treating this debilitation
      condition is BMAC, which use undifferentiated cells found in the bone marrow to promote
      healing and tissue regeneration. These cells have the ability to replicate into a multiple
      different tissue types. With BMAC, the marrow is concentrated provide better healing of the
      damaged tissue and aid in growth and repair. The full benefits of BMAC are still unknown, but
      studies have shown the treatment can reduce swelling, relieve pain, and improve healing in
      articular cartilage and bone grafts.

      Autologous BMAC has shown promising clinical potential as a therapeutic agent in regenerative
      medicine, including the treatment of osteoarthritis and cartilage defects, and the clinical
      efficacy platelet rich plasma has been documented to alleviate symptoms related to knee
      osteoarthritis. However, randomized, prospective comparison of the two techniques has not
      been reported in the literature and long term follow-up for both treatments is limited, and
      especially limited in the use of BMAC for the knee OA treatment.

      From the other hand, HA preparations are widely used in everyday practice for almost 30 years
      with variable results. No one of these therapeutic options are not yet recommended by supreme
      professional organizations ( e.g.AAOS) because of paulacity of scientific data and unbiased
      confirmation of their clinical efficiency with a broad advice for necessity of more rigorous
      clinical trials.
    

Intervention name(s): Bone Marrow Aspirate Concentrate; Leukocyte Rich Platelet Rich Plasma; Hyaluronic Acid
Intervention type(s): Procedure; Procedure; Drug
Intervention description(s): Bone marrow ( 100 ml) is aspirated from proximal tibia, concentrated in Arthrex Angel Centrifuge, and after concentration 6 ml of BMAC is injected in the knee; Blood sample is taken ( 100 ml), centrifuged in Arthrex Angel Centrifuge and after double spinning process about 6 ml of PRP is injected in the knee; Three injections of Cartinorm (1% Sodium Hyaluronat (20mg/2 ml) by Goodwill Pharma) is injected in the knee weekly
Other intervention name(s): BMAC; LR-PRP; HA
Intervention MeSH terms: Hyaluronic Acid
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Patients will be randomly assigned to 3 groups: LR-PRP group, the BMAC group or HA group. Functional scores and outcomes will be compared to determine clinical efficacy of all groups and which treatment is more effective in treating knee OA
Masking: None (Open Label)
Primary purpose: Treatment