A Phase I, Prospective, Randomized, Open-label, Active-Controlled Clinical Trial for Safety Evaluation of Intra-articular Injection of RegenoGel-SP for the Treatment of Moderate to Severe Osteoarthritis
Condition: Osteoarthritis
MeSH terms: Osteoarthritis
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      This is a Phase I, prospective, active-controlled, randomized, open-label, clinical trial
      designed to assess the safety and tolerability of single intra-articular injection of
      RegenoGel-SP for the treatment of OA.

      RegenoGel-SP is composed of fibrinogen in plasma linked to a high molecular weight HA. The
      viscoelastic properties resulting from the combination of these two natural macromolecules is
      further enhanced by joint surface associated factors to generate a viscoelastic gel with
      superior stability and mechanical integrity.
    

Detailed description: 
      Eighteen subjects will be randomized and sequentially assigned to RegenoGel-SP or to
      hyaluronic acid (HA) treatments on a 2:1 basis, respectively. Treatment groups will be
      assigned as per a randomization list that will be prepared prior to the start of the study.
      Randomization will be done at Enrollment (Visit 2). Neither surgeon nor subject will be
      blinded to treatment. Subjects will be monitored for 6 months following treatment. Following
      signing the Informed Consent form (Visit 1), subjects who conform to the inclusion criteria
      will answer questionnaires for grading of their symptoms, pain level and overall functional
      performance. Subjects will be evaluated for vital signs, blood hematology, chemistry, INR,
      aPTT and ECG, and will be subjected to a 30-40ml blood withdrawal that will be used for the
      production of autologous RegenoGel-SP. Subjects randomized to receive RegenoGel-SP will
      receive a single, intra-articular injection (Visit 2), while subjects randomized to receive
      HA treatment (Euflexxa®) will be injected with 3 intra-articular weekly injections of (Visits
      2-4). Subjects treated with RegenoGel-SP will attend visits 3 and 4 but will not receive
      treatment. All subjects will return for Observation visits after 6 weeks, 3 months and 6
      months following treatment (Visits 5-7). During treatment and observation visits, subjects
      will be monitored for safety parameters (local and systemic AEs, blood work analysis ) and
      response to treatment using the above questionnaires.
    

Intervention name(s): intra-articular administration of RegenoGel-SP or hyaluronic acid (HA)
Intervention type(s): Device
Intervention description(s): Intra-articular Injection: single injection of RegenoGel SP or 3 injections of HA
Intervention MeSH terms: Hyaluronic Acid
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Moderate to Severe OA; VAS score of ≥ 5; grade III-IV Kellgren Lawrence of OA; subjects who failed conservative treatment; subjects who candidates for total knee replacement (TKR); subject 45 and 75 years old; subject is experiencing pain in the intended study knee with a VAS score of ≥ 5; subject has a Body Mass Index (BMI) between 18.5 and 35