Hyalofast With BMAC

Condition: Cartilage defects of the knee

Eligibility

Key Inclusion Criteria

  • 18-60 years old
  • Body mass index <35 kg/m²
  • Symptomatic lesion is classified as International Cartilage Repair Society grade 3 or 4

Key Exclusion Criteria

  • Major associated cartilage lesions which require extensive surgical treatment
  • Infections or skin diseases at target knee joint
  • Diagnosed advanced osteoarthritis

Full Study Name

A Prospective, Randomized, Active Treatment-Controlled, Evaluator-Blinded Multicenter Study to Establish the Superiority of Hyaluronan-Based Scaffold (Hyalofast) With Autologous Bone Marrow Aspirate Concentrate (BMAC) in the Treatment of Articular Knee Cartilage Defect in Comparison to Control (Microfracture Treatment) (IRB no. 47749)

Summary

This study focuses on patients who have damage to their knee cartilage. The purpose of the study is to evaluate the safety and effectiveness of Hyalofast, a sterile pad which is soaked in the patient’s own stem cells taken from their hip, called autologous bone marrow aspirate concentrate (BMAC) (a type of biopsy procedure) and inserted into damaged knee cartilage.

This study is also designed to evaluate the investigational use of the SmartPrep BMAC 2 Centrifuge System. Researchers will collect data on how this device works in combination with cells taken from the hip and inserted into the patient’s knee. Participants will be randomly assigned to one of two treatment groups: the first group will receive the investigational Hyalofast with BMAC treatment for knee cartilage damage; the second group will receive the usual standard of care for treatment of knee cartilage damage, which is microfracture surgery. During microfracture surgery, the damaged knee area will be drilled to stimulate bleeding, and a clot will form. As a result of the bleeding, cells will release and form new cartilage to fill in the defect.


Principal Investigator

Ralph Gambardella, MD

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