GelrinC Implant

GelrinC Implant

GelrinC is an investigational device for patients with articular cartilage damage in their knee. GelrinC is composed of a synthetic material called polyethylene glycol (PEG) and a structurally modified form of human fibrinogen, a protein which in its native form assists healing processes. PEG and native human fibrinogen have been used individually in medical products for many years with excellent results. GelrinC’s unique mode of action relies upon its ability to be implanted as a liquid so that it completely fills the defect, and then be cured into a gel that enables the body's own stem cells to settle on its surface. Over a period of six to 12 months, the GelrinC is gradually resorbed by the body and replaced by new cartilage tissue. Preliminary clinical studies in Europe have indicated that this regenerated tissue provides excellent improvement in pain and function.

Watch this video to find out more about the GelrinC procedure.

GelrinC Compared to Other Surgical Treatments

The table below shows how GelrinC compares to other surgical interventions for the treatment of cartilage damage.

Cell-based
Products
Cartilage
Graft
Advanced
Hydrogel
Implant
MACI™ OATS GelrinC
Suitable for All Lesions No No Yes
Number of Surgical Procedures 2 1 1
Requires Removal of Healthy Cartilage Yes Yes No
Requires Advanced Planning Yes
(8-12 weeks)
Sometimes
(2-4 weeks)
No
Procedure Time 1-3 hours 15-45 mins 10 min add-on
to standard
microfracturing
Return to daily activities 4-5 months 6-8 weeks 6-8 weeks

GelrinC Publications

In addition to the ongoing clinical study, GelrinC has been extensively studied throughout its design and development. Below is a selection of studies on materials science and engineering and early clinical results.

Berdichevski A, Shachaf Y, Wechsler R, Seliktar D. Protein composition alters in vivo resorption of PEG-based hydrogels as monitored by contrast-enhanced MRI. Biomaterials. 2015 Feb;42:1-10. doi: 10.1016/j.biomaterials.2014.11.015. Epub 2014 Dec 9.

Goldshmid R, Cohen S, Shachaf Y, et al. Steric Interference of Adhesion Supports In-Vitro Chondrogenesis of Mesenchymal Stem Cells on Hydrogels for Cartilage Repair. Nature. Scientific Reports volume 5, Article number: 12607 (2015). DOI: 10.1038/srep12607.

Trattnig S, Ohel K, Mlynark , Juras V, Zbyn S, Korner A. Morphological and compositional monitoring of a new cell-free cartilage repair hydrogel technology – GelrinC by MR using semi-quantitative MOCART scoring and quantitative T2 index and new zonal T2 index calculation. Osteoarthritis and Cartilage. 2015(23)12; 2224-2232. https://doi.org/10.1016/j.joca.­2015.07.007.

Sage Clinical Study

The SAGE study is a Food and Drug Administration (FDA) Investigational Device Exemption (IDE) clinical study comparing GelrinC to microfracture, the current standard of care treatment for damaged knee cartilage. The multi-center Phase III pivotal study will enroll 120 patients. All patients who meet study requirements and agree to enter the study are provided GelrinC as treatment, and their results will be compared to raw level historical data of a microfracture control arm. (NCT03262909)

Following are the main inclusion and exclusion criteria:

Inclusion:

  • Age between 18 and 50.
  • Single contained symptomatic lesion located on the femoral condyle of the femur graded as ICRS III or IV with less than 5 mm of bone loss below the subchondral plate.
  • Lesion size between 1 and 5 cm2 post debridement, less than or equal to 2.5 cm in diameter.
  • BMI ≤35
  • Contralateral knee is asymptomatic, stable, fully functional and not medically treated.

Exclusion:

  • Presence of an additional grade III or IV symptomatic lesion.
  • Recent Osteochondritis Dissecans within 1 year of baseline visit.
  • Untreated ACL and/or PCL deficiency or Complex ligamentous instability of the knee.
  • Patient is excluded if presenting untreated current meniscal tear or if previous menisci resection was within the last 6 months.
  • Previous tendon repair or ligament reconstruction within the last 6 months.
  • Failed Mosaicplasty or ACI or MACI or any other cartilage repair product.
  • Microfracture performed less than 1 year before baseline visit.

If you have patients who would like to be considered for the study, they can visit www.MyKneeStudy.com or call (833) 430-8686.