Articular Cartilage Disorder of KneeNCT05924763
The Clinical Outcome of BiCRI in the Treatment of Chondral and Osteochondral Lesions
A study testing Biphasic Cartilage Repair Implant (BiCRI) in people with Articular Cartilage Disorder of Knee, run by BioGend Therapeutics Co.Ltd at 2 sites in Taiwan.
Trial summary
Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not… Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Articular Cartilage Disorder of Knee
- What is being tested?
- Biphasic Cartilage Repair Implant (BiCRI)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesTaiwan
- Study dates
- 20 May 2019to 18 Aug 2022
- Phase
- Interventional
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- - Age between 16~65 (inclusive) years old presenting with either symptomatic chondral or osteochondral lesion of knee requiring primary surgical intervention. The lesions may include but not limited to following conditions:
- multiple lesions
- lesion that had been treated with microfracture or mosaicplasty but failed.
- The index lesion is ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4
- Willing and able to consent in wiring to participate in the study
Who cannot join
- 1. Rheumatoid arthritis and other inflammatory arthritis 2. The index cartilage lesion requires more than 3 (exclusive) implants 3. Skeletally immature (epiphyses are not closed based on x-ray) 4. Concomitant comorbidities 5. Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively 6. Pregnancy or breast feeding 7. Prisoner 8. Patient is actively participating in another medical device, drug, or biologic investigation (active defines as within the last 30 days prior to signing the consent form) 9. Any condition that is not suitable to participate in the study based on the physician's judgement
Trial locations and contacts
2 sites in 1 country.
Taiwan2 sites
En Chu Kong Hospital
New Taipei City
Ministry of Health and Welfare Shuang-Ho Hospital
New Taipei City
About this study
Official title: The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.
Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not limited to more than one (1) lesion and the lesion that had been treated with microfracture or mosaicplasty but failed.
Read the detailed description
Patients who qualify for this trial and who are interested in participating will be consented using an Institutional Review Board (IRB) approved Informed Consent. Once a patient has signed the Informed Consent Form he/she is considered enrolled in the trial. If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.
Clinical trial eligibility should be determined by confirmation that the patient meets the criteria included in the Protocol. Standard arthroscopic technique should be used to fully assess the joint and determine if the chondral or osteochondral defect is appropriate for inclusion in the study. Through arthroscopic examination after initial debridement, the investigator should use his best judgment to estimate the size of the lesion, and the number of BiCRI to be applied.
Plain radiographs and MRI prior to 6-month (inclusive) visit will be performed according to routine clinical practice; however, 12-month and 24-monthpostoperative images should be done for study outcome evaluation
- Conditions
- Articular Cartilage Disorder of Knee
- Being tested
- Biphasic Cartilage Repair Implant (BiCRI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biphasic Cartilage Repair Implant (BiCRI)Device
The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and β-triCalcium phosphate (TCP).
| Study group | Role | What they receive |
|---|---|---|
| BiCRI | Experimental | Biphasic Cartilage Repair Implant Receives: Device: Biphasic Cartilage Repair Implant (BiCRI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
International Knee Documentation Committee-2000 Subjective Knee Evaluation
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
Measured: 24 months after operation
International Knee Documentation Committee-2000 Knee Examination Form
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Measured: 24 months after operation
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
Measured: 24 months after operation
Pain (visual analogue scale;VAS)
Pain (visual analogue scale;VAS) compare to baseline
Measured: 24 months after operation
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Measured: 24 months after operation
Secondary outcomes (5)
International Knee Documentation Committee-2000 Subjective Knee Evaluation
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
Measured: 12 months after operation
International Knee Documentation Committee-2000 Knee Examination Form
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Measured: 12 months after operation
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
Measured: 12 months after operation
Pain (visual analogue scale;VAS)
Pain (visual analogue scale;VAS) compare to baseline
Measured: 12 months after operation
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Measured: 12 months after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2023
- Study start20 May 2019
- Primary completion10 Jun 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage Disorder of KneeStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioGend Therapeutics Co.Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Gwen Chang, Study director, BioGend Therapeutics Co.Ltd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05924763
- Sponsor's protocol ID
- CR18-001
- Status last verified
- Jan 2023
- First submitted
- 25 May 2023
- Last updated
- 25 Sep 2025
- 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 25 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Clinical Outcome of the Biphasic Cartilage Repair Implant (BiCRI) in the Treatment of Chondral and Osteochondral Lesions of the Knee.
- ClinicalTrials.gov ID
- NCT05924763
- Acronym / sponsor ID
- CR18-001
- Conditions
- Articular Cartilage Disorder of Knee
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- BioGend Therapeutics Co.LtdIndustry (pharma, biotech, devices)
- Study start
- 20 May 2019 (actual)
- Primary completion
- 10 Jun 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 29 Jun 2023 (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.
Based on the previous successful experiences, the investigators like to extend our patient population. In this study, the investigators aim to determine the safety and effectiveness of the Biphasic Cartilage Repair Implant (BiCRI) in the treatment of chondral and osteochondral lesions of the knee, including but not limited to more than one (1) lesion and the lesion that had been treated with microfracture or mosaicplasty but failed.
Detailed description
Patients who qualify for this trial and who are interested in participating will be consented using an Institutional Review Board (IRB) approved Informed Consent. Once a patient has signed the Informed Consent Form he/she is considered enrolled in the trial. If during surgery the size of lesion is found to meet exclusion criteria, the subject will be considered withdrawn (screen failure) from the trial.
Clinical trial eligibility should be determined by confirmation that the patient meets the criteria included in the Protocol. Standard arthroscopic technique should be used to fully assess the joint and determine if the chondral or osteochondral defect is appropriate for inclusion in the study. Through arthroscopic examination after initial debridement, the investigator should use his best judgment to estimate the size of the lesion, and the number of BiCRI to be applied.
Plain radiographs and MRI prior to 6-month (inclusive) visit will be performed according to routine clinical practice; however, 12-month and 24-monthpostoperative images should be done for study outcome evaluation
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BiCRI | Experimental | Device: Biphasic Cartilage Repair Implant (BiCRI)Biphasic Cartilage Repair Implant |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- - Age between 16~65 (inclusive) years old presenting with either symptomatic chondral or osteochondral lesion of knee requiring primary surgical intervention. The lesions may include but not limited to following conditions:
- The index lesion is ICRS grade 3-4 lesion, Outerbridge grade 4, or OCD grades 3-4
- Willing and able to consent in wiring to participate in the study
Key exclusion criteria (1 listed)
- 1. Rheumatoid arthritis and other inflammatory arthritis 2. The index cartilage lesion requires more than 3 (exclusive) implants 3. Skeletally immature (epiphyses are not closed based on x-ray) 4. Concomitant comorbidities 5. Local or systemic infection, not including asymptomatic urinary tract infection if treated with antibiotics preoperatively 6. Pregnancy or breast feeding 7. Prisoner 8. Patient is actively participating in another medical device, drug, or biologic investigation (active defines as within the last 30 days prior to signing the consent form) 9. Any condition that is not suitable to participate in the study based on the physician's judgement
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 |
|---|---|---|
| Biphasic Cartilage Repair Implant (BiCRI)The Biphasic Cartilage Repair Implant (BiCRI) is a two-phase scaffold composed of poly(lactic-co-glycolic acid) (PLGA) and β-triCalcium phosphate (TCP). | Device | BiCRI |
Primary outcome
International Knee Documentation Committee-2000 Subjective Knee Evaluation
Time frame: 24 months after operation
International Knee Documentation Committee-2000 Subjective Knee Evaluation compare to baseline
International Knee Documentation Committee-2000 Knee Examination Form
Time frame: 24 months after operation
International Knee Documentation CommitteeC-2000 Knee Examination Form compare to baseline
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 24 months after operation
Knee Injury and Osteoarthritis Outcome Score (KOOS) compare to baseline
Pain (visual analogue scale;VAS)
Time frame: 24 months after operation
Pain (visual analogue scale;VAS) compare to baseline
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Time frame: 24 months after operation
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
5 secondary outcomes
International Knee Documentation Committee-2000 Subjective Knee Evaluation
Time frame: 12 months after operation
International Knee Documentation Committee-2000 Knee Examination Form
Time frame: 12 months after operation
Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time frame: 12 months after operation
Pain (visual analogue scale;VAS)
Time frame: 12 months after operation
Magnetic Resonance Observation of Cartilage Repair Tissue (MOCART) scale
Time frame: 12 months after operation
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 25 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Gwen Chang study director
BioGend Therapeutics Co.Ltd
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biphasic Cartilage Repair Implant (BiCRI) in people with Articular Cartilage Disorder of Knee, run by BioGend Therapeutics Co.Ltd at 2 sites in Taiwan.
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 1 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 25 Sep 2025. 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 Taiwan. 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.
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?
International Knee Documentation Committee-2000 Subjective Knee Evaluation (time frame: 24 months after operation). The study lists 5 primary outcomes in all. 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 25 Sep 2025.