CARTISTEM Study

Study Overview

We are looking for patients with symptomatic knee osteoarthritis who have tried at least three months of conservative treatment without lasting relief and who are not yet ready to consider knee replacement surgery. Candidates should have imaging that confirms focal or multifocal cartilage lesions with preserved joint space, mild to moderate osteoarthritis, and reasonable limb alignment. Because the study includes a structured rehabilitation program and follow-up visits over two years, candidates should be motivated and able to commit to the full course of the study.

Who May Qualify

Failed Conservative Treatment
Patients with knee osteoarthritis who have tried conservative options, such as injections, without success, and who are not yet candidates for knee arthroplasty.

Confirmed or Suspected Cartilage Lesions
Imaging that shows or suggests focal or multifocal cartilage lesions, with preserved joint space, mild to moderate osteoarthritis, and reasonable alignment.

Ready to Commit to Rehab and Follow Up
Willingness and ability to complete a structured rehabilitation program and attend follow up visits for the full two year study period.

Sponsor

Multi-site industry-sponsored trial (N≈300)

Research Type

Randomized, prospective, double blind controlled trial

Candidate Criteria

Patients ages 18 to 75 with a BMI of 35 or under, diagnosed with knee osteoarthritis, who have failed at least 3 months of conservative treatment. Candidates must have a Kellgren Lawrence grade of 2 to 3, a specific range of femoral cartilage defect size, and pain and function scores within defined ranges. Full screening and baseline eligibility criteria apply, including limits on recent injections, other joint conditions, and certain medical histories.

Purpose

To compare pain and functional outcomes between CARTISTEM and standard surgical debridement over a two year period in patients with a focal cartilage defect and early-stage knee osteoarthritis.

Study Design

Patients are screened with X-ray, MRI, labs, and questionnaires, then complete a baseline patient-reported outcome visit within 10 days of surgery. On surgery day, half of the participants receive CARTISTEM and half receive debridement only. Patients complete a daily symptom diary between screening and their baseline visit, then again for the 7 days preceding each follow-up visit.

Study Procedures

1. Screening visit: X-ray, MRI, labs, questionnaires
2. Baseline PRO visit (within 10 days of surgery): VAS Pain, WOMAC
3. Surgery day: CARTISTEM or debridement only
4. Follow-up visits at:
   • 2 weeks (MRI)
   • 3 months
   • 6 months
   • 9 months
   • 12 months (MRI, X-ray)
   • 18 months
   • 24 months (MRI, X-ray)

Each follow-up visit includes a physical exam, knee evaluation, medication check, patient-reported outcomes, labs, and diary review.