“CartiLife Hyaline Cartilage Treatment Comes With An Easier Injector”
CartiLife, an autologous cell therapy derived from chondrocyte cartilage for regenerating knee cartilage, will be easier to inject with a new injector, industry officials said.
CartiLife won a conditional agreement from the Ministry of Food and Pharmaceutical Safety in April 2019 to treat knee cartilage defects (ICRS Grade 3 to 4 with defect sizes of 2 to 10 square centimeters).
In clinical trials, 90 percent of patients treated with CartiLife had regenerated cartilage after one year of treatment. The treatment also proved the long-term effect, as the regenerated cartilage was maintained for up to five years.
Additionally, doctors will find it more convenient to perform a CartiLife procedure with a new injector.
Korea Biomedical Review (KBR) met with Jung Min-kyung, Associate Project Manager at Specialty Care BU at Mundipharma Korea, and Lee Jeong-yun, Principal Investigator at Biosolution, to learn about the context of CartiLife’s transformation, clinical trials and sales and marketing plans.
KBR: A ââCartiLife procedure involves cleaning out damaged cartilage and transplanting the cultivated cartilage tissue. The treatment is different from existing therapies in terms of procedure and use of pellet-like tissue. Can you tell us why Biosolution decided to develop this product?
Lee: Unlike existing treatments, a CartiLife procedure involves a simple cleansing of the lesion and transplantation of the prepared tissue without a separate process such as making a small hole in the subchondral bone. So, it takes little time. Therefore, cleaning the damaged cartilage legion is not a tedious task for an orthopedic surgeon. In addition, unlike suspension treatments, CartiLife involves the implantation of solid pellets (beads), which allows the cartilage to fill up more quickly. In addition, CartiLife is the only product in the world based on hyaline cartilage among the approved treatments for knee cartilage defects.
KBR: How did the doctors react for the first time to CartiLife?
Jung: Even in a virtual meeting, they show great interest in explaining the development background of CartiLife, the mechanism of action and the clinical data. We have met many doctors who are interested in clinically experimenting with the most advanced treatment for cartilage defects. After speaking with doctors who have performed CartiLife procedures, we found that over 90 percent of them were satisfied due to a good prognosis three months after the procedure.
KBR: What is CartiLife’s strongest advantage?
Lee: Usually, the cartilage tissue generated by other treatments is usually fibrocartilage. But in the CartiLife treatment, the hyaline cartilage tissue is grown outside and transplanted to the site of the defect. Thus, the quality of the regenerated cartilage is excellent. In addition, the cultivated cartilage tissue is in pellets, which shows greater structural regeneration than conventional suspension treatments. For this reason, the rehabilitation period using CartiLife is six weeks, much shorter than that of existing treatments.
KBR: We have heard that CartiLife’s injector is going to be changed soon. Why do we have to change the injector when it has only been a year and a half since it was put on the market? Also, the existing injector was used until the phase 2 studies. We wonder if there will be a difference in the results of the treatment with the new injector.
Lee: We decided to change the injector to improve the comfort of the doctors. As the product remains the same, the change will not affect the therapeutic effect. The change of injector reflected the opinion of the doctors who had used it after it was put on the market. This reflects the view that lozenges can remain inside the existing silicone NGO catheter. So we designed a funnel shaped injector to get the most out of the product without pellet residue and separately made a pusher to use the remaining pellets.
Jung: This was part of Biosolution’s efforts to actively receive feedback from physicians and find ways to respond quickly.
KBR: When do you plan to change the injector for a new one?
Lee: We have completed the development of the new injector, but we need to submit separate test results and get approval from the Ministry of Food and Pharmaceutical Safety. So we expect the new injector to be used for patient care towards the end of this year or early next year.
KBR: How many medical institutions can perform a CartiLife procedure, and what is their size?
Jung: By the end of August, around 80 hospitals across the country could perform the procedure. About 40 percent of them are teaching hospitals, and the rest are spine and joint hospitals.
KBR: How is the CartiLife trial going?
Lee: CartiLife has obtained conditional approval after a local phase 2 trial, and a phase 3 study has been underway since last year. In May of last year we recruited the first patient and in August we started the procedure in the treatment group. We have recruited 75 patients so far and plan to enroll a total of 104 patients by the end of the year. We have also started a phase 2 study in the United States and started recruiting patients.
KBR: Who are CartiLife’s target patients?
Jung: We have focused our marketing activities on patients 50 years of age or younger with ICRS (International Cartilage Regeneration & Joint Preservation) grade 3 or 4 cartilage defects. Until the start of this year, the average age of patients treated with CartiLife was 46.6 years.
Recently, with the accumulated experience of doctors, the target patient group is expanding in the late 50s or early 60s and even to patients with K&L (Kellgren & Lawrence) Grade 3. At the end of the month As of August of this year, the average age of CartiLife- treated patients rose to around 50.
KBR: Patients may think that more competent medical treatment and a younger patient might increase the effect of cartilage regeneration. Is it true?
Lee: The skill levels of individual doctors do not affect the outcome of treatment due to the simple CartiLife procedure. In a test from the Biosolution laboratory, the effect has nothing to do with age.
A slight difference in the result of regeneration arises from the different cellular characteristics of individual patients rather than age. The authorization of the MFDS states that it can be used regardless of age. Some 70-year-old patients have also received CartiLife procedures.
KBR: Can you explain the long-term follow-up data and side effects of CartiLife?
Lee: We have confirmed the data from the five-year follow-up data from the local phase 1 study. We also plan to continue to follow five-year data from a local phase 2 trial and the 10-year data from the phase 1 study. Until the national phase 2 trial, no serious side effects were reported. Sometimes some patients had their cartilage bulging slightly from the original height of the cartilage, but this was only confirmed by MRI scans, and there was no problem with the naked eye. It did not cause any health problems such as pain.