Articular Cartilage InjuryGCRMNCT04463238
Guided Cartilage Regeneration Membrane
A study testing Guided cartilage regeneration membrane and Microfracture in people with Articular Cartilage Injury and Knee Ligament Injury, run by Peking University Third Hospital at 8 sites in China.
Trial summary
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Articular Cartilage Injury, Knee Ligament Injury
- What is being tested?
- Guided cartilage regeneration membrane and Microfracture
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 8 sitesChina
- Study dates
- 3 Aug 2020to 3 Aug 2023
- 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 18 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- ≥18 years old and ≤50 years old, regardless of gender
- 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
- Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
Who cannot join
- Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
- Those with stage III or above degeneration of bone and joint
- Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
- Those who are sensitive to collagen, foreign protein or pig-derived materials
- Repair the damaged area> 8 cm2 or <2 cm2, lack of normal cartilage tissue around the injury
- Severe heart, liver and kidney insufficiency are defined as:
Show all 16Show fewer
- Heart function: NYHA grade III or above; ALT, AST> 2.5 times the upper limit of normal value; Serum creatinine> 1.5 times the upper limit of normal value;
- People with systemic immune diseases or systemic or local infections
- Joint fibrosis, joint stiffness, and obviously restricted movement
- Those with moderate or severe osteoarthritis
- People with contraindications for MRI examination
- Patients with hemophilia
- Those who cannot tolerate surgery
- Women who are pregnant or plan to become pregnant and breastfeeding women
- Persons with mental abnormalities and incapacity to act autonomously
- Other conditions that the doctor judges cannot participate in the trial
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
China8 sites
Chinese PLA General Hospital
Beijing, Beijing Municipality, 100853
Zhongli Li, PhD
Zhongli Li, PhD
The First Affiliated Hospital of Kunming Medical College
Kunming, Yunnan, 650032
Yanlin Li, PhD
Yanlin Li, PhD
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
Qing Jiang, PhD
Jin Dai, PhD
Second Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030012
Zhiqiang Zhang, Postgraduate
Junjun Shi, PhD
Zhongnan Hospital
Wuhan, Hubei, 430071
Liaobin Chen, PhD
Biao Chen, PhD
Xi'an Honghui Hospital
Xi’an, Shanxi, 710000
Jiang Zheng, PhD
Jiang Zheng, PhD
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450000
Jianzhong Xu, PhD
Jianzhong Xu, PhD
Zunyi Medical College
Zunyi, Guizhou, 563000
Yi Liu, Bachelor
Hehe Zhong, PhD
About this study
Official title: Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Read the detailed description
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
- Conditions
- Articular Cartilage Injury, Knee Ligament Injury
- Being tested
- Guided cartilage regeneration membrane, Microfracture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided cartilage regeneration membraneCombination product
On the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot.
MicrofractureProcedure or surgery
Operate in accordance with the clinical microfracture surgery method.
| Study group | Role | What they receive |
|---|---|---|
| Cartilage membrane surgery | Experimental | The test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd.
Cartilage regeneration membrane combined with microfracture surgery. Receives: Combination Product: Guided cartilage regeneration membrane; Procedure: Microfracture |
| Microfracture | Other | The control group was treated with microfractures widely recognized at home and abroad. Receives: Procedure: Microfracture |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
The nuclear magnetic evaluation indicators are as follows:
- Cartilage defect repair filling degree;
- Fusion of repair tissue and adjacent normal cartilage;
- Repair tissue surface structure;
- Repair the internal structure of the organization.
The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
Measured: End of surgery to 730 days after surgery
Secondary outcomes (2)
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
The closer the ratio of the regenerated cartilage T2 value to the normal control cartilage T2 value is 1, it means that the regenerated cartilage The closer the water content and collagen arrangement are to normal cartilage.
Measured: At 24 months after surgery
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
The closer the ratio of the regenerated cartilage △R1 value to the normal control cartilage △R1 value is 1, it means that the GAG content of regenerated cartilage is closer to normal cartilage.
Measured: At 24 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2020
- Study start3 Aug 2020 (estimated)
- Primary completion3 Aug 2022 (estimated)
- Study completion3 Aug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Articular Cartilage InjuryStudies of the same condition, open and under way.
- More trials run by Peking University Third HospitalThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- GCRM-3020\\GCRM-4030
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Zhongnan Hospital, Second Hospital of Shanxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Kunming Medical University, Zunyi Medical College, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Xi'an Honghui Hospital
- Responsible party
- Sponsor
- Investigators
- Yingfang Ao, PhD, Principal investigator, Department of Sports Medicine, Peking University Third HospitalXiaoqing Hu, PhD, Study director, Department of Sports Medicine, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04463238
- Sponsor's protocol ID
- 2015035
- Acronym
- GCRM
- Status last verified
- Jul 2020
- First submitted
- 3 Jul 2020
- Last updated
- 9 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- 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 9 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Open Multicenter Clinical Study to Evaluate the Safety and Effectiveness of Guided Cartilage Regeneration Membrane for Repair of Articular Cartilage Injury
- ClinicalTrials.gov ID
- NCT04463238
- Acronym / sponsor ID
- GCRM / 2015035
- Conditions
- Articular Cartilage Injury, Knee Ligament Injury
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Zhongnan Hospital, Second Hospital of Shanxi Medical University, The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School, First Affiliated Hospital of Kunming Medical University, Zunyi Medical College, The First Affiliated Hospital of Zhengzhou University, Chinese PLA General Hospital, Xi'an Honghui Hospital
- Study start
- 3 Aug 2020 (estimated)
- Primary completion
- 3 Aug 2022 (estimated)
- Study completion
- 3 Aug 2023 (estimated)
- First posted
- 9 Jul 2020 (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.
Guided cartilage regeneration membrane for repairing the safety and effectiveness of articular cartilage injury
Detailed description
MRI evaluation using guided cartilage regeneration membrane for articular cartilage injury repair 730 days (2 years) is the main indicator of this trial. In this experiment, we observe the improvement of Lysholm score, VAS score, ratio change of regenerated cartilage T2 value to normal cartilage T2 value, and ratio of regenerated cartilage △R1 value to normal cartilage △R1 value Indicators such as value changes are secondary evaluation indicators.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- GCRM-3020\GCRM-4030
| Arm | Type | Receives |
|---|---|---|
| Cartilage membrane surgery | Experimental | Combination Product: Guided cartilage regeneration membrane, Procedure: MicrofractureThe test group applied the guidance provided by Shaanxi Baiao Regenerative Medicine Co., Ltd. Cartilage regeneration membrane combined with microfracture surgery. |
| Microfracture | Other | Procedure: MicrofractureThe control group was treated with microfractures widely recognized at home and abroad. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- ≥18 years old and ≤50 years old, regardless of gender
- 2 cm2 ≤ articular cartilage defect repair area ≤ 8 cm2, patients with feasible micro-fractures, no contraindications to surgery
- Patients voluntarily participate in clinical trials, sign informed consent forms, and can cooperate with clinical follow-up
Key exclusion criteria (16 listed)
- Those who have participated in clinical trials of other drugs or medical devices in the last 6 months
- Those with stage III or above degeneration of bone and joint
- Those who cannot accept pig-derived devices or have special religious beliefs due to religion, ethnicity and other issues
- Those who are sensitive to collagen, foreign protein or pig-derived materials
- Repair the damaged area> 8 cm2 or <2 cm2, lack of normal cartilage tissue around the injury
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 |
|---|---|---|
| Guided cartilage regeneration membraneOn the basis of microfracture, the blood clot released from the defect area is covered with a guide cartilage regeneration membrane to provide an attached scaffold for the cells in the blood clot. | Combination product | Cartilage membrane surgery |
| MicrofractureOperate in accordance with the clinical microfracture surgery method. | Procedure or surgery | Cartilage membrane surgery, Microfracture |
Primary outcome
MRI evaluation of articular cartilage injury 730 days (2 years) after repair
Time frame: End of surgery to 730 days after surgery
The nuclear magnetic evaluation indicators are as follows: 1. Cartilage defect repair filling degree; 2. Fusion of repair tissue and adjacent normal cartilage; 3. Repair tissue surface structure; 4. Repair the internal structure of the organization. The MRI score of the experimental group before and after treatment increased by an average of 5 points compared with the control group.
2 secondary outcomes
Change in ratio of regenerated cartilage T2 value to normal cartilage T2 value
Time frame: At 24 months after surgery
Change in ratio of regenerated cartilage △R1 value to normal cartilage △R1 value
Time frame: At 24 months after surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jul 2020.
- Individual participant dataSharing planned: No
Related trials for Articular Cartilage Injury
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Knee Cartilage Repair Registry
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RecruitingPhase 1
AMIC Compared With Microfracture for Focal Articular Cartilage Damage of the Hip
Hip Arthroscopy, Articular Cartilage Defect
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Early Feasibility Study of Cartilage Defect Repair
Osteoarthritis, Hip, Femoroacetabular Impingement
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Impact of Bone-Marrow Aspirate Injections in Knee Arthroscopy
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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.
Yingfang Ao, PhD principal investigator
Department of Sports Medicine, Peking University Third Hospital
Xiaoqing Hu, PhD study director
Department of Sports Medicine, Peking University Third Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided cartilage regeneration membrane and Microfracture in people with Articular Cartilage Injury and Knee Ligament Injury, run by Peking University Third Hospital at 8 sites 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 3 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 9 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yingfang Ao, PhD (13401096777 ext. 13401096777, gcrm_bys01@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MRI evaluation of articular cartilage injury 730 days (2 years) after repair (time frame: End of surgery to 730 days after surgery). 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 9 Jul 2020.