Cartilage InjuryNCT07094100
Tissue Engineered Cartilage to Repairing Articular Cartilage Defects
A study testing Tissue engineered cartilage in people with Cartilage Injury and OA Knee, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
Trial summary
The joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Cartilage Injury, OA Knee
- What is being tested?
- Tissue engineered cartilage
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 20 Apr 2026to Dec 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The patients' age ranges from 18 to 65 years old, and gender is not restricted;
- The imaging results show that the epiphyseal growth is mature;
- The defects or localized injuries of joint cartilage caused by trauma or other reasons;
- The injured area is the distal weight-bearing surface of the femoral condyle of the knee joint, with no more than 4 lesions, and there is no injury to the cruciate ligaments;
- The patients voluntarily sign and provide a written informed consent form and are willing to closely cooperate with the doctor's strict postoperative rehabilitation program.
Who cannot join
- The patient is extremely overweight, with a body mass index greater than 35;
- The lower limb alignment is valgus by more than 10° and varus by more than 5°;
- Multiple ligament injuries;
- There are numerous bad habits such as heavy smoking, drug abuse, and excessive alcohol consumption;
- Has undergone open knee joint surgery within the past six months;
- Has severe joint stiffness or fibrosis;
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- Has an allergic constitution or a history of allergic reactions to collagen;
- Has mental abnormalities;
- Cannot or is unwilling to undergo rehabilitation training;
- Has primary cardiovascular diseases, lung diseases, endocrine and metabolic disorders, or other serious diseases that affect their daily life, such as tumors or AIDS;
- Pregnant or lactating women, or those planning to conceive during the trial period;
- Other acute or chronic diseases, for which the researchers consider surgery to be inappropriate.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital of Xinxiang Medical College
Xinxiang, Henan, 453000
Wenjie Ren, 13937354075, 13937354075@163.com
Wenjie Ren, 13937354075@163.com
About this study
Official title: Clinical Study of Cartilage Constructed by Autologous Bone Marrow Mesenchymal Stem Cells in Repairing Articular Cartilage Defects
The joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage.
Read the detailed description
Trauma, degeneration, inflammation, tumors, etc. can all cause damage to the cartilage of human joints. The cartilage has an extremely low self-repairing ability. Once damaged, the damage will become more and more severe over time, accelerating the occurrence and development of osteoarthritis, and causing varying degrees of joint dysfunction and reduced quality of life. Currently, traditional surgical treatments such as joint debridement, microfracture, and mosaic cartilage transplantation only apply to small-scale cartilage injuries, and long-term follow-up has found that the results are not satisfactory. The breakthrough in the core technology of in vitro constructing living cartilage based on tissue engineering principles has brought new hope for the physiological function reconstruction of joint cartilage damage. Cartilage was the first tissue to successfully regenerate using tissue engineering technology, but due to the limitation of the source of seed cells, no significant clinical breakthrough has been achieved. Studies have shown that bone marrow mesenchymal stem cells (BMSCs) are a type of cell with multi-directional differentiation potential (including cartilage and bone differentiation potential). Due to the fact that BMSCs can be autologously collected, the trauma is minimal, and the in vitro expansion ability is strong, therefore, they can meet the dual requirements of "quality and quantity" of seed cells for tissue engineering cartilage, and are very suitable for clinical application in the field of joint cartilage repair. More importantly, BMSCs have good cartilage formation ability. Our research group has established and invented a series of key technologies and methods for inducing BMSCs to form cartilage in vivo and in vitro in previous studies, and by applying BMSCs combined with three-dimensional degradable scaffold materials, we have been able to construct cartilage with a certain volume and morphology even biological joint tissues in vitro. At the same time, the application of autologous BMSCs for in vitro regeneration of cartilage has successfully repaired joint cartilage and bone composite defects in large animals, and especially has successfully carried out the exploratory clinical research of "in vitro construction of cartilage using autologous bone marrow mesenchymal stem cells for repairing joint cartilage defects", and after a 5-year follow-up, it has been confirmed that this technology can achieve satisfactory clinical repair effects. The research purpose of this application project is to use BMSCs combined with three-dimensional materials to construct joint cartilage to achieve the goal of repairing joint cartilage.
- Conditions
- Cartilage Injury, OA Knee
- Being tested
- Tissue engineered cartilage
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tissue engineered cartilageDevice
Cartilage constructed by autologous bone marrow mesenchymal stem cells
| Study group | Role | What they receive |
|---|---|---|
| Tissue-engineered cartilage to repair articular cartilage defects | Experimental | Not described Receives: Device: Tissue engineered cartilage |
What is being measured
The primary outcome is the main question the study is designed to answer.
KSS score
subjective knee clinical and functional score (0-100)score.100 is better in function
Measured: before the operation, at 3, 6, 12 and 24 months after the operation.
Secondary outcomes (3)
Koos scores
subjective knee functional score (0-100)score.100 is better in function
Measured: before the operation, at 3, 6, 12 and 24 months after the operation.
Lysholm score
subjective knee functional score (0-100)score.100 is better in function
Measured: before the operation, at 3, 6, 12 and 24 months after the operation.
WOMAC score
The higher the index, the more severe the osteoarthritis. It is less than 80 for mild cases, 80 to 120 for moderate cases, and more than 120 for severe cases.
Measured: before the operation, at 3, 6, 12 and 24 months after the operation.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2025
- Study start20 Apr 2026 (estimated)
- Primary completionDec 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cartilage InjuryStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical College
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07094100
- Sponsor's protocol ID
- TECOA-2021
- Status last verified
- Jul 2025
- First submitted
- 25 Jun 2025
- Last updated
- 4 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of Cartilage Constructed by Autologous Bone Marrow Mesenchymal Stem Cells in Repairing Articular Cartilage Defects
- ClinicalTrials.gov ID
- NCT07094100
- Acronym / sponsor ID
- TECOA-2021
- Conditions
- Cartilage Injury, OA Knee
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- The First Affiliated Hospital of Xinxiang Medical CollegeUniversity, hospital or other
- Study start
- 20 Apr 2026 (estimated)
- Primary completion
- Dec 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 30 Jul 2025 (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 joint cartilage constructed by combining bone marrow mesenchymal stem cells with three-dimensional materials has achieved the goal of repairing joint cartilage.
Detailed description
Trauma, degeneration, inflammation, tumors, etc. can all cause damage to the cartilage of human joints. The cartilage has an extremely low self-repairing ability. Once damaged, the damage will become more and more severe over time, accelerating the occurrence and development of osteoarthritis, and causing varying degrees of joint dysfunction and reduced quality of life. Currently, traditional surgical treatments such as joint debridement, microfracture, and mosaic cartilage transplantation only apply to small-scale cartilage injuries, and long-term follow-up has found that the results are not satisfactory. The breakthrough in the core technology of in vitro constructing living cartilage based on tissue engineering principles has brought new hope for the physiological function reconstruction of joint cartilage damage. Cartilage was the first tissue to successfully regenerate using tissue engineering technology, but due to the limitation of the source of seed cells, no significant clinical breakthrough has been achieved. Studies have shown that bone marrow mesenchymal stem cells (BMSCs) are a type of cell with multi-directional differentiation potential (including cartilage and bone differentiation potential). Due to the fact that BMSCs can be autologously collected, the trauma is minimal, and the in vitro expansion ability is strong, therefore, they can meet the dual requirements of "quality and quantity" of seed cells for tissue engineering cartilage, and are very suitable for clinical application in the field of joint cartilage repair. More importantly, BMSCs have good cartilage formation ability. Our research group has established and invented a series of key technologies and methods for inducing BMSCs to form cartilage in vivo and in vitro in previous studies, and by applying BMSCs combined with three-dimensional degradable scaffold materials, we have been able to construct cartilage with a certain volume and morphology even biological joint tissues in vitro. At the same time, the application of autologous BMSCs for in vitro regeneration of cartilage has successfully repaired joint cartilage and bone composite defects in large animals, and especially has successfully carried out the exploratory clinical research of "in vitro construction of cartilage using autologous bone marrow mesenchymal stem cells for repairing joint cartilage defects", and after a 5-year follow-up, it has been confirmed that this technology can achieve satisfactory clinical repair effects. The research purpose of this application project is to use BMSCs combined with three-dimensional materials to construct joint cartilage to achieve the goal of repairing joint cartilage.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tissue-engineered cartilage to repair articular cartilage defects | Experimental | Device: Tissue engineered cartilage |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The patients' age ranges from 18 to 65 years old, and gender is not restricted;
- The imaging results show that the epiphyseal growth is mature;
- The defects or localized injuries of joint cartilage caused by trauma or other reasons;
- The injured area is the distal weight-bearing surface of the femoral condyle of the knee joint, with no more than 4 lesions, and there is no injury to the cruciate ligaments;
- The patients voluntarily sign and provide a written informed consent form and are willing to closely cooperate with the doctor's strict postoperative rehabilitation program.
Key exclusion criteria (12 listed)
- The patient is extremely overweight, with a body mass index greater than 35;
- The lower limb alignment is valgus by more than 10° and varus by more than 5°;
- Multiple ligament injuries;
- There are numerous bad habits such as heavy smoking, drug abuse, and excessive alcohol consumption;
- Has undergone open knee joint surgery within the past six months;
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 |
|---|---|---|
| Tissue engineered cartilageCartilage constructed by autologous bone marrow mesenchymal stem cells | Device | Tissue-engineered cartilage to repair articular cartilage defects |
Primary outcome
KSS score
Time frame: before the operation, at 3, 6, 12 and 24 months after the operation.
subjective knee clinical and functional score (0-100)score.100 is better in function
3 secondary outcomes
Koos scores
Time frame: before the operation, at 3, 6, 12 and 24 months after the operation.
Lysholm score
Time frame: before the operation, at 3, 6, 12 and 24 months after the operation.
WOMAC score
Time frame: before the operation, at 3, 6, 12 and 24 months after the operation.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2026.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tissue engineered cartilage in people with Cartilage Injury and OA Knee, run by The First Affiliated Hospital of Xinxiang Medical College at 1 site in China.
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 12 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: looking for participants now, as of the sponsor's last update on 4 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wenjie Ren (8613937354075, 13937354075@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
KSS score (time frame: before the operation, at 3, 6, 12 and 24 months after the operation.). 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 4 May 2026.