IDENTIFYING THE RIGHT PATIENT

Checking the patient's medical history is crucial for better clinical understanding and prognosis. Do take note of the patient's concomitant medication and co­ morbidities, if any. Do ensure the patient is currently not associated with any of the following:

• On-going chemotherapy/radiation treatment

• Previously undergone organ or bone marrow transplant in the last 6 months

• Pregnancy, breast-feeding

• Patients aged below 18 years

• Degenerative joint changes due to osteoarthritis and rheumatoid arthritis

Confirm the Stage of Cartilage Damage: Magnetic Resonance Imaging can be used to determine the Stage and Extent of Cartilage Damage

RECARTA is applicable for ICRS stages (Stage III-IV) without subchondral bone damage

Assessment of candidacy for RECARTA

Staging of knee cartilage damage

Arthroscopic assessment – determining defect size, location, bone involvement

Step 1. CARTILAGE TISSUE BIOPSY

Confirm patients candidacy

Cartilage tissue harvest

A small biopsy of healthy cartilage is taken arthroscopically from a non-weight-baring area of the patient's knee joint (intercondylar notch, the proximal aspect of the medial or lateral femoral condyle) and packaged to RECARTA cartilage tissue harvest transport kit

Coordinate with KELI Therapeutics and the patient to find a suitable RECARTA cell therapy implantation date and time

Refer to the Cartilage Tissue Harvest Manual for the detailed treatment procedure

Step 2. RECARTA PROCESS

The biopsy is shipped to the KELI Therapeutics state-of-the-art facility that provides optimal RECARTA product safety and quality

Chondrocytes are isolated from the biopsy, and cells are cultured for 24±4 days. Rigorous in-process controls and release quality control testing are performed

RECARTA is delivered to a treatment facility at a controlled dose of 1,33 – 2,67 mln. cells per cm2 of defect size

Step 3. RECARTA IMPLANTATION

The cartilage defect is debrided to the healthy, stable cartilage with the ring curette

RECARTA is implanted with a supplied commercial collagen membrane. Use the template provided with the membrane to measure the cartilage defect and cut the membrane to the exact size of the cartilage defect

Before surgery, please Refer to the Implantation manual for step-by-step guidance

RECARTA cells are seeded on the porous side of the membrane and let attach for 10 minutes

RECARTA is implanted in the cartilage defect and checked for stability