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

Trial Summary

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 data supports the effectiveness of the Hyalex Knee Cartilage System treatment?

Research on similar treatments, like Hyalograft C, shows promising results for knee cartilage repair, with most patients experiencing improved knee conditions and quality of life. This suggests that treatments using hyaluronan-based scaffolds, like the Hyalex System, could be effective for cartilage damage. ^{1 2 3 4 5}

Is the Hyalex System for Cartilage Damage safe for humans?

The Hyalex System, evaluated under different names, appears to have a positive safety profile with limited adverse events reported in clinical trials for similar treatments. Common side effects for similar products include mild pain and swelling at the injection site, with rare cases of more serious reactions. ^{3 6 7 8 9}

How is the Hyalex Knee Cartilage System treatment different from other treatments for knee cartilage damage?

The Hyalex Knee Cartilage System is unique because it involves a tissue-engineered approach using a hyaluronan-based scaffold, which simplifies the procedure by eliminating the need for periosteal coverage, reducing surgical time and complications compared to traditional autologous chondrocyte implantation techniques. ^{2 3 10 11 12}

What is the purpose of this trial?

The Hyalex Early Feasibility Study is a prospective, multicenter, open-label, single-arm, 2-phase early feasibility study to evaluate the safety and technical performance of the HYALEX Knee Cartilage System for replacement of loss of articular cartilage and bone of the knee femoral condyles in symptomatic patients who require surgical treatment, will be enrolled in the study and undergo implantation of the HYALEX Knee Implant.

Eligibility Criteria

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

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

Treatment Details

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).

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

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]

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]

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Management of articular cartilage defects of the knee. [2012]

2. England pubmed.ncbi.nlm.nih.gov

Autologous cartilage implantation for full thickness articular cartilage defects of the knee. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Hyaluronan-based scaffolds (Hyalograft C) in the treatment of knee cartilage defects: preliminary clinical findings. [2022]

4. United States pubmed.ncbi.nlm.nih.gov

Long-term Results After Hyaluronan-based MACT for the Treatment of Cartilage Lesions of the Patellofemoral Joint. [2019]

5. Germany pubmed.ncbi.nlm.nih.gov

[Technique of all arthroscopic autologous chondrocyte implantation (ACI) for the treatment of cartilage defects in the knee]. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Safety of intra-articular hyaluronates for pain associated with osteoarthritis of the knee. [2010]

7. England 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. [2019]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Safety and Efficacy of Kartigen® in Treating Cartilage Defects: A Randomized, Controlled, Phase I Trial. [2021]

9. England pubmed.ncbi.nlm.nih.gov

Safety of three different product doses in autologous chondrocyte implantation: results of a prospective, randomised, controlled trial. [2022]

10. Germany 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]. [2019]

11. Brazil pubmed.ncbi.nlm.nih.gov

AUTOLOGOUS CHONDROCYTE TRANSPLANTATION-SERIES OF 3 CASES. [2020]

12. United States pubmed.ncbi.nlm.nih.gov

Matrices for cartilage repair. [2019]