Cartilage InjuryPhase 1NCT04953572
Treatment of Cartilage Defects With Peripheral Blood Stem Cells
A Phase 1 study testing autologous peripheral blood mesenchymal stem cell, Microfracture and Microfracture + collagen membrane in people with Cartilage Injury, run by Peking University Third Hospital at 1 site in China.
Trial summary
Knee joint cartilage cells metabolize slowly, and it is difficult to repair themselves after injury. Any knee joint trauma or the progression of osteoarthritis may lead to the progression of cartilage or osteochondral defects. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Cartilage Injury
- What is being tested?
- autologous peripheral blood mesenchymal stem cell, Microfracture and Microfracture + collagen membrane
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 252 participants
- Where
- 1 siteChina
- Study dates
- 1 Aug 2021to 31 Dec 2023
- 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
- Adults over 18 and under 60, regardless of gender.
- Symptoms, signs and imaging changes are consistent with knee joint limitations IV cartilage defect or patella chondromalacia, patellofemoral joint cartilage injury, mild to moderate knee osteoarthritis.
- Other treatments are ineffective.
- No treatment for other knee cartilage defects during the specified period of the test.
- The subject must be able to communicate well with the researcher and comply with the research requirements, and must give written, signed and dated informed consent before conducting any research-related activities. All relevant legal representatives will also sign a written research agreement in accordance with local laws and regulations.
Who cannot join
- The diameter of the cartilage defect in the patient is less than 5mm.
- Grade Ⅲ and Ⅳ knee joint OA.
- The patient's symptoms and signs are not closely related to the cartilage defect area.
- Suffering from concomitant inflammatory diseases (such as rheumatoid arthritis), osteochondrotis dissecans, sepsis, osteonecrosis, and various tumor diseases in the past; in the past three months, there was in the joint cavity of the affected knee History of injection.
- Suffer from the underlying medical conditions (including but not limited to metabolism, hematology, kidney, liver, lung, nerve , Endocrine, heart, infection, or gastrointestinal tract); currently suffering from a serious progressive or uncontrolled disease that is not suitable for the test or puts it at high risk, including the researchers belief that it will prevent the subject from following the protocol or completing the study according to the protocol Any medical or psychiatric condition of
- Being infected with human immunodeficiency virus (HIV), infectious hepatitis B or hepatitis C or corresponding medical history.
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- Suffer from a progressive infection or malignant disease, and be able to produce chest X-ray, computed tomography (CT scan) or MRI evidence within 12 weeks before screening, and be evaluated and confirmed by a qualified physician.
- Active systemic infections (except colds) or any other infections that will recur regularly in the previous two weeks.
- There is a history of chronic or recurrent infectious diseases, or evidence of tuberculosis infection that was judged to be positive at the time of screening. Subjects who have obtained positive or uncertain results can participate in the study if they undergo a comprehensive tuberculosis examination (according to local practice/guidelines) within 12 weeks before baseline and finally prove that there is no evidence of active tuberculosis. If the presence of latent tuberculosis is confirmed, treatment must be initiated and maintained in accordance with local or national guidelines before the baseline.
- History of lymphoproliferative disease, or any known malignant tumor, or history of malignant tumor of any organ system in the past 5 years (Bowen's disease, basal cell carcinoma, or actinic keratosis after treatment and no evidence of recurrence in the past 12 weeks Except for diseases; except for excised cervical carcinoma in situ or non-invasive malignant colon polyps).
- Suffer from medical problems at the same time, including but not limited to the following:
- Uncontrolled hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥95mmHg), congestive heart failure (New York Heart Association status classification III or IV).
- Subjects whose serum creatinine level exceeds 2.0 mg/dl (176.8 μmol/L).
- Total white blood cell (WBC) count at screening <2500/μL, or platelet <100000/μL or neutrophil <1500/μL or hemoglobin <8.5 g/dL.
- For pregnant or lactating women, pregnancy is defined as the state of a woman after conception until the termination of pregnancy, which is confirmed by the positive result of the hCG laboratory test.
- Women with childbearing potential are defined as all women who are physiologically able to become pregnant, unless they use effective contraceptive methods during the entire study treatment administration period.
- In the six months before the baseline, there is a history of alcohol or drug abuse or evidence of ongoing abuse.
- A history of allergies to the components of the therapeutic drugs used.
- The returning visitors cannot be tracked in time.
Trial locations and contacts
1 site in 1 country.
China1 site
Institute of Sports Medicine, Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Jia-kuo Yu, MD, 86-10-82267392, yujiakuo@126.com
About this study
Official title: Autologous Peripheral Blood Mesenchymal Stem Cell Transplantation for Repair of Degree IV Local Cartilage Injury of Knee Joint
Knee joint cartilage cells metabolize slowly, and it is difficult to repair themselves after injury. Any knee joint trauma or the progression of osteoarthritis may lead to the progression of cartilage or osteochondral defects. Compared with bone marrow mesenchymal stem cells (MSCs), peripheral blood MSCs have better chondrogenic differentiation ability. At the same time, the mobilization of peripheral blood MSCs and the advancement of extraction technology also make it feasible to treat osteochondral damage by using peripheral blood MSCs. The purpose of this study is to evaluate the therapeutic effect of surgical transplantation of autologous peripheral blood MSCs to repair knee joint Ⅳ-degree localized cartilage injury, and to explore a new treatment for osteochondral defects based on the foundation of the research group's previous research.
Read the detailed description
- Explore the clinical efficacy of autologous peripheral blood mesenchymal stem cell transplantation in the treatment of osteochondral defects
- Exploring the characteristics of cartilage regeneration in autologous peripheral blood mesenchymal stem cell transplantation
- Conditions
- Cartilage Injury
- Being tested
- autologous peripheral blood mesenchymal stem cell, Microfracture, Microfracture + collagen membrane, Autologous osteochondral transplantation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
autologous peripheral blood mesenchymal stem cellGenetic
Transplantation of autologous peripheral blood mesenchymal stem cell
MicrofractureProcedure or surgery
Microfracture
Microfracture + collagen membraneCombination product
Microfracture plus collagen membrane transplantation
Autologous osteochondral transplantationProcedure or surgery
Autologous osteochondral transplantation
| Study group | Role | What they receive |
|---|---|---|
| test group | Experimental | Patients in the test group received autologous peripheral blood mesenchymal stem cell therapy Receives: Genetic: autologous peripheral blood mesenchymal stem cell |
| control group 1 | Active comparator | Patients in the control group 1 received microfracture surgical treatment Receives: Procedure: Microfracture |
| control group 2 | Active comparator | Patients in the control group 2 received microfracture combined with surgical treatment of collagen membrane Receives: Combination Product: Microfracture + collagen membrane |
| control group 3 | Active comparator | Patients in the control group 3 received autologous osteochondral transplantation Receives: Procedure: Autologous osteochondral transplantation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Magnetic Resonance Imaging in the 6th month after surgery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the magnetic resonance observation of cartilage repair tissue (MOCART) score of cartilage regeneration in the knee articular cartilage defect area at 6 months after sugery. The MOCART score ranges from 0 to 100 points, the higher the score, the better the repair effect.
Measured: 6 months after sugery
Magnetic Resonance Imaging in the 12th month after surgery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the MOCART score of cartilage regeneration in the knee articular cartilage defect area at 12 months after sugery
Measured: 12 months after sugery
Magnetic Resonance Imaging in the 24th month after surgery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the MOCART score of cartilage regeneration in the knee articular cartilage defect area at 24 months after sugery
Measured: 24 months after sugery
Secondary outcomes (2)
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
The higher the WOMAC osteoarthritis index, the more severe the OA. Evaluate the severity of OA according to the following criteria: less than 80 is mild, 80-120 is moderate, and greater than 120 is severe.
Measured: 3, 6, 12, 18 and 24 months after sugery
International knee documentation committee (IKDC) Knee Joint Score Sheet
IKDC is an internationally recognized score sheet for comprehensive evaluation of the subjective symptoms and objective signs of the knee joint system.
Measured: 3, 6, 12, 18 and 24 months after sugery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2021
- Study start1 Aug 2021 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2023 (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.
- 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 252 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University Third Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Inner Mongolia People's Hospital, Hebei Medical University Third Hospital, Tianjin Hospital
- Responsible party
- Principal investigator, Yu Jiakuo, Peking University Third Hospital
- Investigators
- Jia-kuo Yu, Prof., Study chair, Peking University Third Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04953572
- Sponsor's protocol ID
- PekingUTH001
- Status last verified
- Jun 2021
- First submitted
- 15 Jun 2021
- Last updated
- 8 Jul 2021
- Results posted
- 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 8 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Autologous Peripheral Blood Mesenchymal Stem Cell Transplantation for Repair of Degree IV Local Cartilage Injury of Knee Joint
- ClinicalTrials.gov ID
- NCT04953572
- Acronym / sponsor ID
- PekingUTH001
- Conditions
- Cartilage Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 252 participants (estimated)
- Lead sponsor
- Peking University Third HospitalUniversity, hospital or other
- Collaborators
- Inner Mongolia People's Hospital, Hebei Medical University Third Hospital, Tianjin Hospital
- Study start
- 1 Aug 2021 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 8 Jul 2021 (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.
Knee joint cartilage cells metabolize slowly, and it is difficult to repair themselves after injury. Any knee joint trauma or the progression of osteoarthritis may lead to the progression of cartilage or osteochondral defects. Compared with bone marrow mesenchymal stem cells (MSCs), peripheral blood MSCs have better chondrogenic differentiation ability. At the same time, the mobilization of peripheral blood MSCs and the advancement of extraction technology also make it feasible to treat osteochondral damage by using peripheral blood MSCs. The purpose of this study is to evaluate the therapeutic effect of surgical transplantation of autologous peripheral blood MSCs to repair knee joint Ⅳ-degree localized cartilage injury, and to explore a new treatment for osteochondral defects based on the foundation of the research group's previous research.
Detailed description
- Explore the clinical efficacy of autologous peripheral blood mesenchymal stem cell transplantation in the treatment of osteochondral defects
- Exploring the characteristics of cartilage regeneration in autologous peripheral blood mesenchymal stem cell transplantation
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| test group | Experimental | Genetic: autologous peripheral blood mesenchymal stem cellPatients in the test group received autologous peripheral blood mesenchymal stem cell therapy |
| control group 1 | Active comparator | Procedure: MicrofracturePatients in the control group 1 received microfracture surgical treatment |
| control group 2 | Active comparator | Combination Product: Microfracture + collagen membranePatients in the control group 2 received microfracture combined with surgical treatment of collagen membrane |
| control group 3 | Active comparator | Procedure: Autologous osteochondral transplantationPatients in the control group 3 received autologous osteochondral transplantation |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adults over 18 and under 60, regardless of gender.
- Symptoms, signs and imaging changes are consistent with knee joint limitations IV cartilage defect or patella chondromalacia, patellofemoral joint cartilage injury, mild to moderate knee osteoarthritis.
- Other treatments are ineffective.
- No treatment for other knee cartilage defects during the specified period of the test.
- The subject must be able to communicate well with the researcher and comply with the research requirements, and must give written, signed and dated informed consent before conducting any research-related activities. All relevant legal representatives will also sign a written research agreement in accordance with local laws and regulations.
Key exclusion criteria (19 listed)
- The diameter of the cartilage defect in the patient is less than 5mm.
- Grade Ⅲ and Ⅳ knee joint OA.
- The patient's symptoms and signs are not closely related to the cartilage defect area.
- Suffering from concomitant inflammatory diseases (such as rheumatoid arthritis), osteochondrotis dissecans, sepsis, osteonecrosis, and various tumor diseases in the past; in the past three months, there was in the joint cavity of the affected knee History of injection.
- Suffer from the underlying medical conditions (including but not limited to metabolism, hematology, kidney, liver, lung, nerve , Endocrine, heart, infection, or gastrointestinal tract); currently suffering from a serious progressive or uncontrolled disease that is not suitable for the test or puts it at high risk, including the researchers belief that it will prevent the subject from following the protocol or completing the study according to the protocol Any medical or psychiatric condition of
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 |
|---|---|---|
| autologous peripheral blood mesenchymal stem cellTransplantation of autologous peripheral blood mesenchymal stem cell | Genetic | test group |
| MicrofractureMicrofracture | Procedure or surgery | control group 1 |
| Microfracture + collagen membraneMicrofracture plus collagen membrane transplantation | Combination product | control group 2 |
| Autologous osteochondral transplantationAutologous osteochondral transplantation | Procedure or surgery | control group 3 |
Primary outcome
Magnetic Resonance Imaging in the 6th month after surgery
Time frame: 6 months after sugery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the magnetic resonance observation of cartilage repair tissue (MOCART) score of cartilage regeneration in the knee articular cartilage defect area at 6 months after sugery. The MOCART score ranges from 0 to 100 points, the higher the score, the better the repair effect.
Magnetic Resonance Imaging in the 12th month after surgery
Time frame: 12 months after sugery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the MOCART score of cartilage regeneration in the knee articular cartilage defect area at 12 months after sugery
Magnetic Resonance Imaging in the 24th month after surgery
Time frame: 24 months after sugery
Magnetic Resonance Imaging，including T2-mapping sequence, to evaluate the MOCART score of cartilage regeneration in the knee articular cartilage defect area at 24 months after sugery
2 secondary outcomes
The Western Ontario and McMaster Universities (WOMAC) Osteoarthritis Index
Time frame: 3, 6, 12, 18 and 24 months after sugery
International knee documentation committee (IKDC) Knee Joint Score Sheet
Time frame: 3, 6, 12, 18 and 24 months after sugery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2021.
- 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.
Jia-kuo Yu, Prof. study chair
Peking University Third Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing autologous peripheral blood mesenchymal stem cell, Microfracture and Microfracture + collagen membrane in people with Cartilage Injury, run by Peking University Third Hospital 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 19 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 8 Jul 2021. 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.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jia-kuo Yu, Prof. (+86 13331031448, yujiakuo@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Magnetic Resonance Imaging in the 6th month after surgery (time frame: 6 months after sugery). The study lists 3 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 8 Jul 2021.