Actively Enrolling Trials

 

A Prospective Multicenter Open-label Randomized Controlled Trial of Agili-C™ vs. Surgical Standard of Care (SSOC) for the Treatment of Joint Surface Lesions of the Knee

This study looks to compare the safety and efficacy of the Agili-C™ implant to other surgical stand of care (SSOC) treatments for joint surface lesions of the knee. This study is randomized, which means that you will either receive the Agili-C™ implant or a control surgery. The two types of control surgeries that you may receive are microfracture or debridement, depending on your age, lesion size, and how much arthritis you have in your knee.

This implant is made of two components. The first is a cylinder that is placed onto the bone and is made of coral, which has a similar structure to bone. The second is a liquid called hyaluronic acid (HA), which is a synthetic version of the lubricating liquids normally found in your knee. This liquid is placed on top of the coral component. Both are expected to be absorbed over time and replaced by new tissue. Because it is investigational, the Agili-C™ implant is only available as part of this study. 

Who is eligible: Patients who have joint surfaces lesions that cause pain in the knee and affect activities.

 

Evaluation of the ReNu™ Amniotic Suspension Allograft after Marrow Stimulation in the Treatment of Osteochondral Defects

This open-label clinical trial assesses the safety and efficacy of the ReNu knee injection for patients who undergo marrow stimulation surgery. The injection is a suspension made from amniotic membrane and amniotic fluid stem cells. The ReNu is given two weeks and one month after your surgery to see if it helps improve the results of your surgery. If you choose to participate, you will be asked to make visits for up to two years after your surgery. 

Who is eligible: Patients who have joint surfaces lesions and are scheduled to undergo marrow stimulation surgery.

ReNu injection is also available clinically separate from participation in this trial. Please contact the office to arrange for an appointment (please note that stem cell injections are not covered by insurance).

 

For more information on any of the clinical trials above or to see if you might be eligible, please contact Dr. Gomoll's research assistant, Danielle Digirolamo at digirolamod@hss.edu.


Completed Trials or Closed to enrollment

 

Verify the Effectiveness of the NUsurface® (VENUS) 

The VENUS study compares the NUsurface meniscus implant to non-surgical standard of care treatment (including physical therapy, injections, bracing). 

This implant is an artificial device made from polycarbonate-urethane (PCU) and reinforced with Ultra High Molecular Weight Polyethylene fibers. It is designed to function similarly to a natural meniscus in distributing the contact pressure and joint load of the knee.  

This study is closed to enrollment and is in the follow-up stage at Brigham and Women's.

For more information, click here.

 

An Investigation of the ReNu™ Knee Injection in Patients With Osteoarthritis

This randomized, clinical trial assessed the efficacy of the ReNu knee injection for patients with symptomatic knee osteoarthritis.  The injection is a suspension made from amniotic membrane and amniotic fluid stem cells.  Patients were randomly assigned to one of three study groups: stem cell injection, joint lubrication injection (Monovisc, high molecular weight hyaluronan injection), or saline (placebo) injection.  If a patient's pain did not improve after 3 months within the study, and the patient had not received a stem cell injection, he/she was able to choose to have an injection with ReNu™. Patients were followed for one year after their injections. This study is complete.

 

Atlas Knee System

This clinical trial assesses the Atlas Knee System in treating symptomatic patients with medial (inside) compartment knee osteoarthritis.  The Atlas Knee System is designed to absorb excess joint load in the diseased medial compartment of the knee.  The central spring component of the Atlas System provides compressive load absorption to treat symptoms of pain and to improve knee function and is intended to delay the need for knee replacement in the young, active, but arthritic patient.

This study is closed to enrollment and is in the follow-up stage at Brigham and Women's.

 

Cartistem® 

The Cartistem® study was a Phase I/IIa clinical trial, investigating the implantation of a product consisting of human umbilical cord blood-derived mesenchymal stem cells and sodium hyaluronate.  This trial investigated the efficacy of the Cartistem® product to regenerate cartilage and to decrease pain following implantation. This trial is complete.

 

Flexion FX006 (Zilretta®)

The Flexion FX006 clinical trial assesses the safety and tolerability of repeat administration of FX006 (two doses of 40 mg FX006) in patients with symptomatic osteoarthritis (OA) of the knee. FX006 is an extended-release formulation of triamcinolone acetonide (TCA) for intravenous administration that is being developed for the treatment of patients with pain attributed to OA of the knee. FX006 delivers TCA to the synovial and peri-synovial tissues for approximately three months depending on the dose administered.

FX006 was FDA-approved as Zilretta® in October 2017 for single intra-articular dosing to treat symptomatic knee osteoarthritis. The purpose of this study is to evaluate the safety and efficacy of repeat dosing so that ultimately Zilretta® can be approved for such use.

This study is closed to enrollment and is in the follow-up stage at Brigham and Women's.