JOCOAT Safety and Tolerability Clinical Trial GLAD-04

Launched by ARC MEDICAL INC. · Jul 21, 2025

Keywords

ClinConnect Summary

This clinical trial is testing the safety and effectiveness of a new liquid product called JOCOAT™ APN-3003, which is designed to help prevent surgical adhesions—scar tissue that can form after knee ligament surgery. Specifically, the study focuses on patients aged 15 to 25 who are having a common knee surgery called anterior cruciate ligament reconstruction (ACLR) using a tendon from the thigh. At the end of their surgery, these patients will receive the JOCOAT liquid to see if it helps improve recovery and reduce complications compared to previous patients who had similar surgeries without this treatment.

To take part, patients need to have a torn ACL and be undergoing this surgery for the first time, with certain factors that increase the risk of the new graft failing—such as playing competitive sports that involve quick changes in direction, having certain knee movement patterns, or loose ligaments. Participants will be closely monitored before, during, and after surgery to check how well the product works and to ensure it’s safe. It’s important to note that people with previous knee surgeries, certain allergies, or other medical conditions may not be eligible. This study is currently not recruiting but aims to enroll up to 24 young patients at a single center.

Gender

ALL

Eligibility criteria

• Pre-operative Inclusion Criteria:
• • Understand and be able to follow the requirements of the protocol including personally signing and dating an REB approved Informed Consent Form prior to undergoing any protocol related procedures
• • Subjects aged 15 to 25 years with an ACL-deficient knee undergoing primary ACLR
• • Subjects with skeletal maturity (i.e. closed epiphyseal growth plates on standard knee radiographs)
• * At least two of the following factors that are associated with a high risk of graft failure:
• • 1. participate in a competitive pivoting sport (defined as sports that include cutting and pivoting activities such as basketball, American football, soccer, lacrosse, volleyball, tennis/squash, handball, downhill skiing etc);
• • 2. have a pivot shift of grade 2 or greater;
• • 3. have generalized ligamentous laxity (Beighton score of \>= 4) and/or genu recurvatum \> 10 degrees
• • Biological females have a negative pregnancy test within 4 days of initial surgery
• • Is willing, able and likely to fully comply with clinical trial procedures and restrictions including follow-ups
• Pre-operative Exclusion Criteria:
• • Simultaneous bilateral ACLR
• • Previous ACLR on either knee
• • Less than one year from contralateral knee or contralateral/ipsilateral hip/ankle surgery
• • Prior arthrotomy in the study knee
• • Active infection anywhere or previous infection in the study knee
• • History of peri-articular fracture in study knee
• • \> 3 degrees of asymmetric varus or valgus
• • The patient has debilitating knee pain that would preclude the use of QT tissue as a graft
• • The patient has a significant quad tendonitis that would preclude the use of QT tissue as a graft
• • Known or suspected allergy to brown seaweed, seaweed-based materials such as fucoidan, food allergies and/or presence of any allergy related dietary restrictions unless deemed by the investigator as "Not Clinically Significant"
• • Known or suspected allergy to fucose, galactose, sulfur, sulfate, sulfite, or any sugar-based polymer or polysaccharides containing these
• • Known hypersensitivity to sodium lactate or sulfur-containing compounds
• • Any other severe allergic conditions or previous reactions (e.g., anaphylactic reactions, angioedema)
• • Severe metabolic acidosis or alkalosis
• • Have insulin dependent diabetes, severe diabetes and/or poorly controlled diabetes mellitus
• • Any general medical or surgical condition that would preclude a standard knee ACLR
• • Inflammatory arthropathy
• • Breast feeding
• • Have a medical condition that, in the opinion of the investigator would interfere with the evaluation of the safety or efficacy of the investigational product
• • Have received any investigational products that, in the opinion of the investigator, would interfere with the evaluation of the safety or efficacy of the investigational product
• • Have clinically relevant hemochromatosis, hepatic, renal, autoimmune, lymphatic, hematological or coagulation disorders
• • Family history of blood or coagulation disorders
• • History of heparin-induced thrombocytopenia (HIT) or known sensitivity to heparin-like products
• Intra-operative Inclusion Criteria:
• • - Patient undergoes primary anatomic anterior cruciate ligament reconstruction surgery with quadriceps tendon (QT) graft
• Intra-operative Exclusion Criteria:
• • Pre-existing arthrofibrosis in the knee
• • Partial ACL rupture (defined as one bundle ACL tear requiring reconstruction/ augmentation of the torn bundle with no surgery required for the intact bundle) where ACLR is not performed
• • Multiple ligament injury (two or more ligaments requiring surgery)
• • Symptomatic articular cartilage defect requiring treatment other than debridement
• • Articular cartilage lesion that requires any other surgical treatment apart from debridement
• • Under anesthetic, this patient has a symmetrical or grade 1 pivot shift AND has a Beighton score \<4 AND \<10 degrees hyperextension