Traumatic Cartilage InjuryPhase 1TCL-aMSC-eOCTNCT06400862
Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
A Phase 1 study testing eOCT implantation in people with Traumatic Cartilage Injury, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Traumatic Cartilage Injury
- What is being tested?
- eOCT implantation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 2 sitesHong Kong
- Study dates
- 28 Feb 2024to 31 Jul 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: Subjects who are in the age range of 18-60 years
- Location: Single symptomatic cartilage defect on medial or lateral femoral condyle
- Size \& Containment: Contained single focal cartilage lesion of size ~1-4 cm square
- Grading: Cartilage damage ICRS/Outerbridge grade III/IV reaching subchondral bone (As diagnosed by MRI)
- Conservative treatments failed (for > 4 months)
Who cannot join
- Disease Factor---
- Previous cartilage repair surgery (OATS or ACI/MACI) in the index knee
- Previous injectional treatments such as HA/PRP/stem cell in the index knee within 3 months before informed consent
- Presence of a clinically relevant patellofemoral cartilage lesion in the index knee (patella/trochlea/both)
- Inflammatory joint disease (specific or non-specific arthritis)
- Metabolic diseases (gout or rheumatism)
Show all 30Show fewer
- Advanced Osteoarthritis (Radiologically apparent degenerative joint disease in the target knee as determined by Kellgren \& Lawrence Grade >2)
- Osteochondritis dissecans
- Multiple or uncontained lesions as detected by MRI or arthroscopy
- Uncorrected ligament deficiency
- Uncorrected varus or valgus malalignment exceeding 5°
- Ongoing Infection or skin diseases at target knee joint
- Significant meniscal loss
- Patient Factor---
- Subjects who are not able or not willing to give voluntary, written informed consent to participate in this study
- Skeletal immaturity
- Female subjects who are pregnant or lactating
- Body mass index > 30 kg/m2
- Malignancy
- Steroid therapy by systemic or intra-articular route within the last 60 days before informed consent or intramuscular or oral steroids within the last 30 days before informed consent
- Contraindications to MR imaging
- Drug addiction (including narcotic, anesthetic or alcohol addiction)
- Patients who are at higher risk for post-surgical bleeding (e.g., bleeding disorder; taking anticoagulants except low dose aspirin
- Patients who are at higher risk for post-surgical infection (e.g., taking immunosuppressants; have a severe infection or a history of serious infection)
- Known allergy to porcine/bovine collagen
- Any concomitant painful or disabling disease of the spine, hips, or lower limbs that would interfere with evaluation of the afflicted knee
- Patients with human immunodeficiency virus, hepatitis, or syphilis
- Any clinically significant or symptomatic vascular or neurologic disorder of the lower extremities
- Poor general health condition as judged by investigator
- Unable to do follow up
Trial locations and contacts
2 sites in 1 country.
Hong Kong2 sites
Queen Elizabeth Hospital
Kowloon
Prince of Wales Hospital
Shatin
About this study
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.
Read the detailed description
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.
- Conditions
- Traumatic Cartilage Injury
- Being tested
- eOCT implantation
- Keywords
- traumatic knee cartilage injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
eOCT implantationCombination product
eOCT is regarded as an Advanced Therapy Product (ATP).
| Study group | Role | What they receive |
|---|---|---|
| eOCT Treatment | Experimental | In a pre-treatment visit, bone marrow aspiration will be conducted to harvest autologous bone marrow for mesenchymal stem/stromal cells (MSCs) isolation for subsequent eOCT manufacturing. Cartilage lesion will be addressed in the treatment visit by delivering eOCT through arthroscopic surgery roughly 13 weeks after the pre-treatment visit. Receives: Combination Product: eOCT implantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety 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.
Measured: From subject enrollment to 24 months after the eOCT implantation.
Secondary outcomes (10)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From subject enrollment to 24 months after the eOCT implantation.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From subject enrollment to 24 months after the eOCT implantation.
Patient Satisfaction Questionnaire
Patient Satisfaction Questionnaire evaluates three key domains related to postoperative outcomes: (1) overall satisfaction with the procedure, (2) satisfaction with pain relief, and (3) satisfaction with functional improvement in daily activities, recreational activities, and sports participation. Each item is rated using a 4-point Likert scale (Very satisfied, Satisfied, Dissatisfied, Very dissatisfied). The instrument provides descriptive information on the participant's perceived benefit of treatment and supports the assessment of patient-centred outcomes.
Measured: At 24 months after the eOCT implantation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2024
- Study start28 Feb 2024
- Primary completion31 Jul 2026
- Study completion31 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Cartilage InjuryStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chan Pui Barbara, Chinese University of Hong Kong
- Investigators
- Barbara Pui CHAN, PhD, Principal investigator, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06400862
- Sponsor's protocol ID
- eOCT
- Acronym
- TCL-aMSC-eOCT
- Status last verified
- Oct 2026
- First submitted
- 9 Mar 2024
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treating Patients With Traumatic Chondral Lesions With Autologous Bone Marrow Cells Derived Engineered Tissues - Engineered Osteochondral Tissue
- ClinicalTrials.gov ID
- NCT06400862
- Acronym / sponsor ID
- TCL-aMSC-eOCT / eOCT
- Conditions
- Traumatic Cartilage Injury
- Keywords
- traumatic knee cartilage injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 31 Jul 2026 (actual)
- Study completion
- 31 Jul 2026 (actual)
- First posted
- 6 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| eOCT Treatment | Experimental | Combination Product: eOCT implantationIn a pre-treatment visit, bone marrow aspiration will be conducted to harvest autologous bone marrow for mesenchymal stem/stromal cells (MSCs) isolation for subsequent eOCT manufacturing. Cartilage lesion will be addressed in the treatment visit by delivering eOCT through arthroscopic surgery roughly 13 weeks after the pre-treatment visit. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age: Subjects who are in the age range of 18-60 years
- Location: Single symptomatic cartilage defect on medial or lateral femoral condyle
- Size \& Containment: Contained single focal cartilage lesion of size ~1-4 cm square
- Grading: Cartilage damage ICRS/Outerbridge grade III/IV reaching subchondral bone (As diagnosed by MRI)
- Conservative treatments failed (for > 4 months)
Key exclusion criteria (30 listed)
- Disease Factor---
- Previous cartilage repair surgery (OATS or ACI/MACI) in the index knee
- Previous injectional treatments such as HA/PRP/stem cell in the index knee within 3 months before informed consent
- Presence of a clinically relevant patellofemoral cartilage lesion in the index knee (patella/trochlea/both)
- Inflammatory joint disease (specific or non-specific arthritis)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| eOCT implantationeOCT is regarded as an Advanced Therapy Product (ATP). | Combination product | eOCT Treatment |
Primary outcome
Safety Outcomes
Time frame: From subject enrollment to 24 months after the eOCT implantation.
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.
10 secondary outcomes
Visual Analogue Scale (VAS)
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: From subject enrollment to 24 months after the eOCT implantation.
The Western Ontario and McMaster University Osteoarthritis index (WOMAC)
Time frame: From subject enrollment to 24 months after the eOCT implantation.
World Health Organization Quality of Life Instruments (WHOQOL-BREF)
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Short-Form- 36 (SF-36)
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Kellgren and Lawrence (K&L) grading
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) Score 2.0
Time frame: From subject enrollment to 24 months after the eOCT implantation.
T2 mapping signal
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Cartilage thickness
Time frame: From subject enrollment to 24 months after the eOCT implantation.
Patient Satisfaction Questionnaire
Time frame: At 24 months after the eOCT implantation.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Traumatic Cartilage Injury
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Recruiting
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Anterior Cruciate Ligament Injuries, Post-traumatic Osteoarthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Barbara Pui CHAN, PhD principal investigator
Chinese University of Hong Kong
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing eOCT implantation in people with Traumatic Cartilage Injury, run by Chinese University of Hong Kong at 2 sites in Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety Outcomes (time frame: From subject enrollment to 24 months after the eOCT implantation.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.