Hyalex System for Cartilage Damage

Recruiting at 3 trial locations

Overseen By Chris Cain

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Hyalex Orthopaedics, Inc.

Must not be taking: Immunosuppressants, Steroids

Disqualifiers: Diabetes, Smoking, Inflammatory arthropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

Duration: Surgical procedure

20 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new knee implant called the Hyalex Knee Cartilage System. It aims to help individuals with painful knee cartilage damage that hasn't improved with treatments like physical therapy or injections. Participants should have a stable knee with specific cartilage damage on the femoral condyle (the rounded end of the thigh bone) and must have tried non-surgical treatments for at least four weeks without relief. The trial's goal is to assess the safety and effectiveness of this implant for those requiring surgery to alleviate knee pain. As an unphased trial, it offers patients the chance to explore a new treatment option that could potentially enhance their quality of life.

Do I need to stop taking my current medications for the trial?

The trial protocol does not specify if you need to stop taking your current medications, but it excludes those currently undergoing immunosuppressive therapy or long-term steroid use within 3 months prior to surgery.

What prior data suggests that the Hyalex Knee Cartilage System is safe for knee cartilage replacement?

Research shows that the Hyalex Knee Cartilage System has been used successfully in early human studies. These studies check for safety issues such as implant rejection, dislocation, and infection. Although detailed information on side effects isn't available, testing in humans suggests a degree of safety. Early human trials help determine if the treatment is safe before wider use. So far, no specific information points to serious side effects, which is encouraging for potential participants. ^{1 2 3 4 5}

Why are researchers excited about this trial?

The Hyalex Knee Cartilage System is unique because it offers a new approach to treating cartilage damage in the knee. Unlike traditional methods such as microfracture surgery or autologous chondrocyte implantation, which rely on the body's ability to generate new cartilage, the Hyalex system involves implanting a synthetic cartilage material. This synthetic implant is designed to mimic the properties of natural cartilage, potentially providing a more durable and long-lasting solution. Researchers are excited about this treatment because it could significantly reduce pain and improve mobility for patients, offering an alternative for those who haven't responded well to current options.

What evidence suggests that the Hyalex Knee Cartilage System is effective for cartilage damage?

Research has shown that the Hyalex Knee Cartilage System, which participants in this trial will receive, could be a promising treatment for knee cartilage damage. Early results suggest that this implant can help repair the knee joint surface in individuals with cartilage damage and early signs of arthritis. The system is designed to function like a natural knee joint, which is crucial for proper knee movement. Initial tests indicate it may improve mobility by replacing damaged cartilage. Although still in early testing, these findings offer hope for those needing surgery for knee problems. ^{2 3 4 6 7}

Are You a Good Fit for This Trial?

This trial is for individuals with knee cartilage injuries or damage who need surgery. Specific details about who can join are not provided, but typically participants would have symptoms that require surgical intervention and meet certain health standards.

Inclusion Criteria

21-65 years.

Body Mass Index (BMI) ≤ 35.

Singular treatable joint surface lesion, ICRS Grade 3 or 4, located on the medial or lateral femoral condyle.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo implantation of the HYALEX Knee Cartilage Implant

Surgical procedure

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

• Hyalex Knee Cartilage System

Trial Overview The Hyalex Early Feasibility Study is testing the safety and how well the HYALEX Knee Cartilage System works. This system is designed to replace damaged knee cartilage and bone in patients' femoral condyles (part of the thigh bone that makes up the knee joint).

How Is the Trial Designed?

Group I: Hyalex Knee Cartilage System Experimental Treatment 1 Intervention

Implantation of the Hyalex Knee Cartilage Implant

Hyalex Knee Cartilage System is already approved in United States, European Union for the following indications:

Approved in United States as HYALEX Knee Cartilage System for:

• Replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients

Approved in European Union as HYALEX Knee Cartilage System for:

• Replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients

Who Is Running the Clinical Trial?

Hyalex Orthopaedics, Inc.

Lead Sponsor

Trials

2

Recruited

40+

Published Research Related to This Trial

Autologous chondrocyte transplantation is a promising treatment for large chondral defects in the knee, particularly in young patients, as it repairs the defect with tissue similar to hyaline cartilage without damaging the subchondral bone.

The study reports on three cases at the Institute of Orthopedics and Traumatology, indicating that this technique may offer biological and mechanical advantages over other treatment methods for knee cartilage injuries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

AUTOLOGOUS CHONDROCYTE TRANSPLANTATION-SERIES OF 3 CASES. Gobbi, RG., Demange, MK., Barreto, RB., et al.[2020]

Autologous cartilage implantation (ACI) shows potential benefits for treating full thickness articular cartilage defects in the knee, with one study indicating 88% of patients had excellent or good results after one year compared to 69% with mosaicplasty, although this was only significant in a specific subgroup.

Overall, the evidence does not demonstrate a significant difference in effectiveness between ACI and other treatments like mosaicplasty or microfracture, highlighting the need for more high-quality, long-term studies to better assess ACI's efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Autologous cartilage implantation for full thickness articular cartilage defects of the knee. Wasiak, J., Clar, C., Villanueva, E.[2020]

In a study of 32 patients with full-thickness cartilage lesions in the patellofemoral joint, hyaluronan-based matrix-assisted autologous chondrocyte transplantation (MACT) showed significant and stable improvements in knee function over a 10-year follow-up period, with no observed worsening of symptoms.

Despite the overall success, a small number of patients (4) did not achieve significant improvement, particularly among females with patellar defects, highlighting the need for careful patient selection and monitoring.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term Results After Hyaluronan-based MACT for the Treatment of Cartilage Lesions of the Patellofemoral Joint. Kon, E., Filardo, G., Gobbi, A., et al.[2019]

The study involved 98 patients with deep cartilage defects in the knee, and after an average follow-up of about 31 months, the results showed good outcomes, particularly for larger defects, with no technique-specific complications reported.

Postoperative management included early weight-bearing and a structured rehabilitation program, which contributed to positive subjective scores on knee function assessments (IKDC and KOOS) averaging 66 and 73 points, respectively.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Technique of all arthroscopic autologous chondrocyte implantation (ACI) for the treatment of cartilage defects in the knee]. Schlumberger, M., Schuster, P., Bülow, HJ., et al.[2020]

Articular cartilage injuries in the knee are challenging to treat due to the limited self-repair capacity of hyaline cartilage, leading to various controversial treatment options.

Current treatment methods include microfracture, osteochondral transplantation, and chondrocyte implantation, with ongoing research and clinical trials aimed at determining the most effective approaches for restoring cartilage integrity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Management of articular cartilage defects of the knee. Redler, LH., Caldwell, JM., Schulz, BM., et al.[2012]

Kartigen®, a graft made from stem cell-derived chondrocyte precursors, was found to be safe for use in knee cartilage repair, with no adverse events such as infections or tumors reported over a 2-year follow-up period.

Patients receiving Kartigen® showed significant improvements in knee function scores (IKDC) at 16 weeks and maintained higher scores over two years compared to preoperative levels, while the control group (microfracture) experienced a decline in scores after the first year.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Kartigen® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial. Liu, YL., Yen, CC., Liu, TT., et al.[2021]

In a phase II trial involving 75 patients with knee cartilage defects, the three-dimensional autologous chondrocyte implantation product chondrosphere® was found to be generally safe, with no fatal adverse events and no significant differences in adverse events across different dose levels over a 36-month observation period.

The treatment was well tolerated, with only two serious adverse events reported (arthralgia and chondropathy), which occurred years after implantation, indicating that chondrosphere® does not pose significant immediate safety concerns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial. Becher, C., Laute, V., Fickert, S., et al.[2022]

A survey of 230 medical departments in Germany revealed that orthopedic surgeons are more likely to use advanced techniques like autologous chondrocyte transplantation (ACT) and osteochondral transplantation (OCT) for treating knee cartilage defects compared to trauma surgeons.

Only a small percentage (5.2%) of surgeons utilize periosteal grafting, indicating a lack of consensus and varied approaches in the treatment of local cartilage defects in the knee.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Current treatment modalities for cartilage defects at the knee--results of a nation-wide survey of surgical trauma and orthopaedic clinics in Germany]. Lüring, C., Anders, S., Bäthis, H., et al.[2019]

Current techniques for repairing cartilage defects are shifting towards methods that promote the regeneration of hyaline cartilage, which is more effective than previous fibrocartilaginous repair methods.

Key challenges remain in developing tissue-engineered cartilage implants, including identifying the best materials for the implant matrix, selecting the optimal cell sources, and determining the most effective use of growth factors to enhance cartilage repair.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Matrices for cartilage repair. Coutts, RD., Healey, RM., Ostrander, R., et al.[2019]

A clinical trial involving 7 patients with severe osteoarthritis demonstrated that a stem cell-based treatment using allogeneic human umbilical cord blood-derived mesenchymal stem cells (hUCB-MSCs) was safe and effective for regenerating articular cartilage, with improvements in pain and function lasting over 7 years.

The treatment led to the formation of hyaline-like cartilage, and no serious adverse events such as tumor formation were reported, indicating a promising approach for long-term cartilage repair in osteoarthritic knees.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cartilage Regeneration in Osteoarthritic Patients by a Composite of Allogeneic Umbilical Cord Blood-Derived Mesenchymal Stem Cells and Hyaluronate Hydrogel: Results from a Clinical Trial for Safety and Proof-of-Concept with 7 Years of Extended Follow-Up. Park, YB., Ha, CW., Lee, CH., et al.[2019]

Hyalograft C, a new treatment for knee cartilage defects using expanded autologous chondrocytes on a hyaluronan scaffold, has been successfully used in over 600 patients, showing a positive safety profile with few adverse events.

In a study of 67 patients with a mean follow-up of 17.5 months, 97% reported improvement in knee conditions and 94% in quality of life, indicating that Hyalograft C is an effective option for treating acute cartilage lesions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Hyaluronan-based scaffolds (Hyalograft C) in the treatment of knee cartilage defects: preliminary clinical findings. Pavesio, A., Abatangelo, G., Borrione, A., et al.[2022]

Sodium hyaluronate and hylan G-F 20 are safe intra-articular injections for knee osteoarthritis, with the most common side effects being mild pain and swelling at the injection site.

Clinical data shows that while rare adverse events like pseudogout and severe acute inflammatory reactions can occur, overall, hyaluronic acid therapy is considered a safe option for pain relief in osteoarthritis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. Hammesfahr, JF., Knopf, AB., Stitik, T.[2010]

Citations

1. hyalex.com hyalex.com/hyalex-knee-system/

HYALEX® Knee System The HYALEX® Knee Implant has been designed to address this gap and restore the knee joint surface in a single surgical treatment.

2. hyalex.com hyalex.com/clinical-studies/

HYALEX® Knee Cartilage System Clinical Studies Hyalex Orthopaedics is conducting two prospective, multi-center, single-arm clinical studies of the HYALEX® Knee Cartilage System in the US and Europe.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06368700

NCT06368700 | The Hyalex Early Feasibility Study (EFS) To assess the safety (implant rejection, implant dislocation or disassociation (delamination), infection) and tolerability of the Hyalex Knee Cartilage Implant.

4. hyalex.com hyalex.com/initial-results-of-hyalex-freestyle-knee-implant-first-in-human-clinical-studies-to-be-presented-at-the-isakos-congress-2025/

Initial Results of Hyalex Freestyle Knee Implant First-in- ... The HYALEX Freestyle Knee Implant is designed to enable patients suffering from cartilage damage and early osteoarthritis of the femoral condyle(s) to regain ...

5. sabrinastrickland.com sabrinastrickland.com/fda-approves-ide-freestyle-knee-implant/

FDA Approves IDE Application for Freestyle Knee Implant “In our early clinical evaluations, the HYALEX Freestyle Knee Implant demonstrated exceptional promise in mimicking natural joint mechanics and ...

6. hyalex.com hyalex.com/hyalex-orthopaedics-reports-treatment-of-first-patients-with-novel-hyalex-knee-cartilage-system/

Hyalex Orthopaedics Reports Treatment of First Patients ... Patients have successfully received HYALEX Knee Implants as part of the company's first-in-human clinical trials of its novel HYALEX Knee Cartilage System.

7. prnewswire.com prnewswire.com/news-releases/data-from-first-in-human-clinical-studies-of-the-hyalex-freestyle-knee-implant-to-be-presented-at-the-icrs-congress-2025-302574184.html

Data from First-in-Human Clinical Studies of the Hyalex ... The HYALEX Freestyle Knee Implant is designed to enable patients suffering from cartilage damage and early osteoarthritis of the femoral ...