The objective of the study is to establish the safety profile of the autologous engineered osteochondral tissues (eOCT) in treating traumatic chondral lesions in patients.
TCL-aMSC- eOCT is a single arm first-in-human trial designed to establish the safety profile of autologous tissue engineered osteochondral tissue (eOCT) in patients with traumatic chondral lesions. Patient selection will base on medical records, especially MRI results, and other criteria. Patient enrollment and informed consent will be conducted at the baseline visit. In a pre-treatment visit, bone marrow aspiration will be conducted to harvest autologous bone marrow for mesenchymal stem/stromal cells (MSCs) isolation and subsequent eOCT manufacturing. Cartilage lesion will be repaired in the treatment visit by delivering eOCT through arthroscopic surgery roughly 13 weeks after the pre-treatment visit. Rehabilitation will be conducted post-implantation. Multiple follow-up visits will be conducted up to 24 months post-implantation, data including adverse events, clinical and functional scoring and blood tests will be collected during each follow-up visit. Radiological assessment such as magnetic resonance imaging (MRI) will be conducted regularly until the end of the study.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
9
eOCT is regarded as an Advanced Therapy Product (ATP).
Queen Elizabeth Hospital
Jordon, Hong Kong
RECRUITINGPrince of Wales Hospital
Shatin, Hong Kong
RECRUITINGSafety Outcomes
Incidence of Adverse events/ Serious adverse events (AEs/SAEs). To establish the safety profile of the autologous engineered osteochondral tissues (eOCT) from the data collected on adverse events/ serious adverse events.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Visual Analogue Scale (VAS)
The Visual Analogue Scale (VAS) measures pain intensity of the participants, where 0 represents no pain and 10 represents the worst pain imaginable.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
KOOS is a specialized tool designed to gather patients' perspectives on their knee and associated problems. It evaluates both short-term and long-term consequences of knee injury and has five subscales to assess the knee: pain symptoms, activities of daily living, sport and recreation function and knee-related quality of life.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
The Western Ontario and McMaster University Osteoarthritis index (WOMAC)
WOMAC is a widely used questionnaires to evaluate the functional condition of participant's hip and knee osteoarthritis. It includes 3 subscales: pain, stiffness, and physical functioning of the joints, and assess the activities of daily living, functional mobility, gait, general health and the quality of life.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
WHOQOL-BREF is a quality-of-life scale developed through the World Health Organization which contains 26 items.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
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Short-Form- 36 (SF-36)
The SF-36 health survey has 36 questions to measure the functional health and general well-being of a participant. It is a reliable and validated measure that summarizes the participants' physical and mental health.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Kellgren and Lawrence (K&L) grading
K\&L grading is a common method of classifying the severity of osteoarthritis (OA) using five grades.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score 2.0
MOCART 2.0 scoring will occur by independent assessment to evaluate the cartilage repair tissue. The score is a 7-part and 24-item scoring system, also resulting in a final cartilage repair tissue score between 0 and 100 points; 0 points represent the worst imaginable score, 100 points represent the best imaginable score.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
T2 mapping signal
The value T2 mapping signal represents continuous data of the T2 mapping signal intensity at the defect site relative to that of the surrounding uninjured cartilage, with arbitrary units, measuring the quality of the cartilage at the defect site.
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Cartilage thickness
Cartilage thickness (mm) of cartilage lesion and neighboring normal cartilage measured by specific sequence.
Time frame: From subject enrollment to 24 months after the eOCT implantation.