Intra Articular Injection of Microfat and PRP in Knee Osteoarthritis
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      The hypothesis of this project is that the injection of an innovative treatment (microfat and
      dose of autologous PRP) allows to delay knee arthroplasty in patients with knee OA resistant
      to medical treatment.
    

Detailed description: 
      Osteoarthritis is the most common joint disease in the world and one of the most common
      causes of pain and functional disability. The incidence of cartilage pathology has grown due
      to the ageing population, and the increase in sports participation and its associated trauma.
      The treatment of these cartilage damage is limited and remains a major public health issue.

      The aim of the medical treatment and intra articular injections consists in reducing pain and
      improving the knee function in order to limit the sport, professional and social negative
      impact in the youngest patients. Nevertheless their efficacy remain non predictable in
      patients.

      The arthroplasty will be proposed in the final intention. Insofar arthroplasty is a surgical
      procedure 1 / which presents a potential infectious risk associated with its invasive nature,
      2 / it requires iterative revision surgery, especially in young patients given the limited
      lifetime of the implants and 3 / whose complete postoperative recovery take several months,
      it seems justified to continue studies to validate effective alternative treatments to delay
      the use of joint replacements.

      Recently, the emergence of biotherapy in orthopedics has developed the use of intra-articular
      injections of platelet-rich plasma (PRP). Their use has increased substantially and is based
      on the demonstration that platelet-rich plasma concentrate growth factors, can stimulate
      cartilage regeneration in vitro and in vivo preclinical models. In humans, recent data from
      the literature show that these autologous products are very well tolerated. Their scientific
      evaluation remains difficult in that 1 / indications and surgical procedures are not
      harmonized 2 / manufacturing processes PRP are not standardized 3 / quantitative and
      qualitative composition of PRP is rarely documented.

      PRP administration procedures can be optimized: indeed in that, it is a liquid preparation
      (platelet suspension), its administration in a interface tissue allows to limit its spread
      and potentiate its trophic effect on the injured cartilage site. Adipose tissue is the most
      relevant interface tissue given, because it's a tissue rich in stem cells with full
      therapeutic potential and is easily accessible by subcutaneous minimally invasive procedure.
      Thus, autologous microfat (fat removed under local anesthesia by manual liposuction using
      fine cannulas specific) administered in the synovial capsule, could play the matrix to
      receive the injection of PRP.

      The hypothesis of this project is that the standardized injection of an innovative treatment
      (microfat and dose of autologous PRP) allows to delay knee arthroplasty in patients with knee
      OA resistant to medical treatment. This treatment, minimally invasive and with economically
      reasonable cost, would provide a new treatment for second intention. In terms medicoeconomic
      if this treatment is effective over a period of several years, even in cases where it is
      necessary to do it one or two times, it would significantly reduce the financial and societal
      impact of joint replacements.
    

Intervention name(s): Autologous biologic drug of innovative therapy /cell therapy drug
Intervention type(s): Drug
Intervention description(s): Articular knee injection of microfat associated with a dose of 3 billions of platelets or associated with a dose of 1 billion of platelets or with saline solution
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective, monocentric randomised, double blind
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: knee; osteoarthritis; microfat; platelet rich plasma