Shane A. Shapiro, M.D.

Closed for Enrollment

• A Phase 0 Study, ELISA Analysis of Blood and Synovial Fluid Biomarkers in Subjects with Arthritic Joints Compared to Non-Arthritic Joints Jacksonville, Fla.

  The primary objective of this study is to evaluate biomarkers using ELISA testong of synovial fluid from arthrtiic vs non arthritic knees. Synovial fluid samples collected in this study will be compared to synvial fluid samples from IRB 20-009091

• Characterization of Orthobiologic Agents Used for Point of Care Ultrasound Guided Procedures and Associated Outcomes Rochester, Minn., Minneapolis, Minn., Jacksonville, Fla.

  The purpose of this study is to determine patient and manufacturing factors that influence orthobiologic agent (OBA) product components and determine how they may influence patient outcomes.

• Comparative Evaluation of the Performance and Safety of A-CP HA Kit, for the Preparation of a Combination of Platelet Rich Plasma and Hyaluronic Acid, Versus Hyaluronic Acid Alone and Placebo in Patients With Knee Osteoarthritis Jacksonville, Fla.

  The purpose of this study is to determine if a treatment based on the combination of platelet rich plasma and HA obtained with the A-CP HA Kit is statistically superior to a saline placebo or HA alone in terms of Improvement of OA-related symptoms between baseline(D0) and Month 6, and reduction of pain at walking between baseline (D0) and Month 6.

   

   

• Lipoaspirate or Bone Marrow Collection from Healthy Volunteers Jacksonville, Fla.

  The purpose of this study is the use of bone marrow aspirate and lipoaspirate obtained from healthy volunteers to support protocol development, basic product (cell) characterization and pre-clinical trials.

• Platelet Counts in BMAC compared to PRP Jacksonville, Fla.

  The purpose of this study is to assess and compare regenerative injection therapies such as bone marrow aspiration and concentration (BMAC) and platelet rich plasma (PRP) for osteoarthritis.

• Safety and Feasibility of Intra-articular Transplantation of Autologous Adipose Derived Stromal Vascular Fraction (SVF) for Treatment of Osteoarthritis of the Knee Jacksonville, Fla.

  The purpose of this study is to determine the safety and feasibility of autologous, adipose derived stromal vascular fraction injections in the treatment of knee osteoarthritis.

• Use of Human Autologous Bone Marrow Aspirate Concentrate in Painful Knee Osteoarthritis, a Randomized Placebo Controlled Pilot Study (BMAC) Jacksonville, Fla.

  The overall goal of this study is to develop regenerative cell therapy for use in patients with osteoarthritis (OA). The primary objective of this proposal is to conduct a pilot study that assesses the safety and feasibility of using concentrated bone marrow aspirate containing MSC to treat patients with painful knee OA.