CARTISTEM for Osteoarthritis

(CARTISTEM23-01 Trial)

This trial tests a new treatment called CARTISTEM® for individuals with knee osteoarthritis. CARTISTEM® combines special stem cells from umbilical cords with a gel to help reduce knee pain and improve function. The study compares CARTISTEM® combined with a procedure called debridement to debridement alone. It also examines whether CARTISTEM® can slow the progression of osteoarthritis. Suitable candidates have chronic knee osteoarthritis, have not found relief with other treatments like physical therapy or pain medications, and experience knee pain and cartilage damage. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking treatment for knee osteoarthritis.

You may need to stop taking some of your current medications. Participants must stop using all pain medications at least 48 hours before the baseline assessment and each follow-up visit, except for acetaminophen for breakthrough pain. Limited use of NSAIDs is allowed, but there must be a break before scheduled assessments.

Research shows that CARTISTEM®, a treatment derived from stem cells in umbilical cord blood, is generally safe. Previous studies found that patients, particularly those with severe knee cartilage issues, tolerated it well over 24 months. Most participants did not experience serious side effects.

These studies focused on knee osteoarthritis, where cartilage deterioration leads to pain and stiffness. The use of stem cells with a gel-like substance did not result in major health problems.

Unlike the standard treatments for osteoarthritis, which typically include pain management through medications like NSAIDs and corticosteroids, CARTISTEM offers a novel approach by using stem cells to regenerate damaged cartilage. This treatment combines stem cells with a debridement procedure, aiming to not just alleviate symptoms but also repair the underlying joint damage. Researchers are excited about CARTISTEM because it holds the potential to not only relieve pain but also improve joint function and durability by directly addressing the root cause of cartilage degeneration.

Studies have shown that CARTISTEM® can greatly improve knee movement and reduce pain for people with osteoarthritis. Research indicates that this treatment helps grow stronger cartilage compared to other methods. Clinical results have remained consistent for up to seven years, with no major side effects reported. In this trial, one group of participants will receive CARTISTEM® combined with debridement, while another group will undergo only the debridement procedure. Patients treated with CARTISTEM® have experienced significant improvements in their condition. These positive results suggest that CARTISTEM® could be a promising option for those suffering from knee osteoarthritis.¹⁶⁷⁸⁹