Knee OsteoarthritisPhase 1/2NCT03955497
Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury
A Phase 1/2 study testing Autologous Adipose-derived Mesenchymal Stem Cell Gel, Sodium Hyaluronate and Extraction of abdominal fat in people with Knee Osteoarthritis and Cartilage Degeneration, run by Qilu Hospital of Shandong University at 1 site in China.
Trial summary
This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Knee Osteoarthritis, Cartilage Degeneration
- What is being tested?
- Autologous Adipose-derived Mesenchymal Stem Cell Gel, Sodium Hyaluronate and Extraction of abdominal fat
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Oct 2018to 1 Dec 2022
- Phase
- Phase 1/2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18-65 years, male and female, patient can tolerate surgery;
- Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
- Obviously extra-articular malformation;
- Good contralateral interventricular cartilage;
- Course of disease ≥ six months;
- There was no obvious abnormality in tumor marker detection,or patient was evaluated has not at the risk of cancer;
- Subjects who understand and sign the consent form for this study.
Who cannot join
- Acute joint injury;
- Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
- Cancer patients;
- Women who are pregnant or breast feeding,or allergic constitution patient;
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
- Receive other open surgery related to knee operation within 6 months;
- Participation in another clinical trial;
- Failing to comply with the inclusion criteria, unwilling to comply with the research approach, or incomplete data affecting the curative effect or safety judgment.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Qilu hospital of Shandong University
Jinan, Shandong, 250012
Songlin Li, MD, 053182166541, bysonglin@126.com
Heran Ma, Ph.D, +8617364590020, 2523129824@qq.com
About this study
Official title: Efficacy and Safety Research of Autologous Adipose-derived Mesenchymal Stem Cell Gel in the Treatment of Cartilage Damage in the Knee
This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.
Read the detailed description
The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Being tested
- Autologous Adipose-derived Mesenchymal Stem Cell Gel, Sodium Hyaluronate, Extraction of abdominal fat
- Keywords
- Knee Osteoarthritis, Stem Cell, Cartilage repair
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Autologous Adipose-derived Mesenchymal Stem Cell GelOther
The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.
Sodium HyaluronateDrug
Also called hyaluronic acid
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Extraction of abdominal fatProcedure or surgery
Also called Fat extraction
In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.
| Study group | Role | What they receive |
|---|---|---|
| Autologous Adipose-derived Mesenchymal Stem Cell Gel | Experimental | The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation. Receives: Other: Autologous Adipose-derived Mesenchymal Stem Cell Gel; Procedure: Extraction of abdominal fat |
| sodium hyaluronate | Placebo comparator | The control group received intra-articular injection of sodium hyaluronate one month after operation. Receives: Drug: Sodium Hyaluronate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital for special surgery knee score postoperative 1 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 1 month
Hospital for special surgery knee score postoperative 3 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 3 month
Hospital for special surgery knee score postoperative 6 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 6 month
Hospital for special surgery knee score postoperative 12 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 12 month
Hospital for special surgery knee score postoperative 24 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 24 month
Hospital for special surgery knee score postoperative 36 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Measured: postoperative 36 month
Visual Analogue Scale Postoperative Day 1
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day 1
Visual Analogue Scale Postoperative Day 2
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day 2
Visual Analogue Scale Postoperative Day 3
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day 3
Visual Analogue Scale Postoperative Day 7
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day 7
Visual Analogue Scale Postoperative 1 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 1 month
Visual Analogue Scale Postoperative 3 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 3 month
Visual Analogue Scale Postoperative 6 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 6 month
Visual Analogue Scale Postoperative 12 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 12 month
Visual Analogue Scale Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative Day One
Visual Analogue Scale Postoperative 24 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 24month
Visual Analogue Scale Postoperative 36 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Measured: Postoperative 36 month
Evaluation of cartilage repair under MRI postoperative 12 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Measured: Postoperative 12 month
Evaluation of cartilage repair under MRI postoperative 24 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Measured: Postoperative 24 month
Evaluation of cartilage repair under MRI postoperative 36 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Measured: Postoperative 36 month
Degree of meniscus injury under MRI postoperative 12 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus.
But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Measured: postoperative 12 month
Degree of meniscus injury under MRI postoperative 24 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus.
But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Measured: postoperative 24 month
Degree of meniscus injury under MRI postoperative 36 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus.
But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Measured: postoperative 36 month
Evaluation of cartilage repair under arthroscope postoperative 12 month
The arthroscopic classification of knee joint cartilage injury refers to the classification criteria formulated by the International Association of Cartilage Repair, which includes 0-IV grades, of which: 0 grade is normal articular cartilage; 1 grade is the surface injury of cartilage with soft edema on the surface, with only small cracks and intact structure; 2 grade is partial cartilage injury, which extends downward from the surface, but the depth of injury is less than 50% cartilage thickness. Grade III, deep articular injury, injury depth > 50% cartilage thickness or through the whole layer; Grade IV, deep articular cartilage injury to the bone cortex, full-thickness cartilage defect, subchondral bone exposure.
Measured: postoperative 12 month
Degree of meniscus injury under arthroscope postoperative 12 month
The degree of meniscus injury under arthroscopy was classified into three grades, including normal, degenerative and tear.
Measured: postoperative 12 month
Secondary outcomes (6)
Squatting to Standing Time postoperative 1 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 1 month
Squatting to Standing Time postoperative 3 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 3 month
Squatting to Standing Time postoperative 6 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 6 month
Squatting to Standing Time postoperative 12 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 12 month
Squatting to Standing Time postoperative 24 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 24 month
Squatting to Standing Time postoperative 36 month
The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.
Measured: postoperative 36 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2019
- Study start1 Oct 2018
- Primary completion1 Oct 2022 (estimated)
- Study completion1 Dec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Qilu Hospital of Shandong UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Hospital of Shandong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peilai Liu, MD, Study chair, Qilu Hospital of Shandong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03955497
- Sponsor's protocol ID
- 2018023
- Status last verified
- Sep 2020
- First submitted
- 14 May 2019
- Last updated
- 16 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
Publications
Yu D, Xu J, Liu F, Wang X, Mao Y, Zhu Z. Subchondral bone changes and the impacts on joint pain and articular cartilage degeneration in osteoarthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):929-934. Epub 2016 Aug 31.
PubMed 27606839Wilusz RE, Sanchez-Adams J, Guilak F. The structure and function of the pericellular matrix of articular cartilage. Matrix Biol. 2014 Oct;39:25-32. doi: 10.1016/j.matbio.2014.08.009. Epub 2014 Aug 27.
PubMed 25172825Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.
PubMed 22577397Chareancholvanich K, Pornrattanamaneewong C, Narkbunnam R. Increased cartilage volume after injection of hyaluronic acid in osteoarthritis knee patients who underwent high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Jun;22(6):1415-23. doi: 10.1007/s00167-013-2735-1. Epub 2013 Oct 27.
PubMed 24162762
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Research of Autologous Adipose-derived Mesenchymal Stem Cell Gel in the Treatment of Cartilage Damage in the Knee
- ClinicalTrials.gov ID
- NCT03955497
- Acronym / sponsor ID
- 2018023
- Conditions
- Knee Osteoarthritis, Cartilage Degeneration
- Keywords
- Knee Osteoarthritis, Stem Cell, Cartilage repair
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Qilu Hospital of Shandong UniversityUniversity, hospital or other
- Study start
- 1 Oct 2018 (actual)
- Primary completion
- 1 Oct 2022 (estimated)
- Study completion
- 1 Dec 2022 (estimated)
- First posted
- 20 May 2019 (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.
This study was aimed to evaluate the efficacy and safety of Autologous Adipose-derived Mesenchymal Stem Cell Gel combine with High tibial osteotomy therapy in the treatment of cartilage damage in the knee. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.
Detailed description
The patients who will underwent high tibial osteotomy were randomly divided into the experimental group and the control group. Abdominal fat extraction before operation in experimental group to prepare Adipose-derived Mesenchymal Stem Cell Gel, while the control group only underwent high tibial osteotomy. One month after operation, the experimental group was injected with Adipose-derived Mesenchymal Stem Cell Gel into the joint cavity, and the control group was injected with sodium hyaluronate in the joint cavity. Two groups of patients were followed up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Autologous Adipose-derived Mesenchymal Stem Cell Gel | Experimental | Other: Autologous Adipose-derived Mesenchymal Stem Cell Gel, Procedure: Extraction of abdominal fatThe experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation. |
| sodium hyaluronate | Placebo comparator | Drug: Sodium HyaluronateThe control group received intra-articular injection of sodium hyaluronate one month after operation. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 18-65 years, male and female, patient can tolerate surgery;
- Clinical diagnosis of degenerative arthritis by Radiographic Criteria;
- Obviously extra-articular malformation;
- Good contralateral interventricular cartilage;
- Course of disease ≥ six months;
Key exclusion criteria (8 listed)
- Acute joint injury;
- Patients with severe primary diseases, such as cardiovascular,cerebrovascular, liver, kidney and hematopoietic system, and psychosis;
- Cancer patients;
- Women who are pregnant or breast feeding,or allergic constitution patient;
- Positive serology for HIV-1 or HIV-2, Hepatitis B (HBsAg, Anti-Hepatitis C virus -Ab), Hepatitis C (Anti-hepatitis C virus -Ab) and syphilis;
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 Adipose-derived Mesenchymal Stem Cell GelThe experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation. | Other | Autologous Adipose-derived Mesenchymal Stem Cell Gel |
| Sodium HyaluronateAlso: hyaluronic acidThe control group received intra-articular injection of sodium hyaluronate one month after operation. | Drug | sodium hyaluronate |
| Extraction of abdominal fatAlso: Fat extractionIn the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel. | Procedure or surgery | Autologous Adipose-derived Mesenchymal Stem Cell Gel |
Primary outcome
Hospital for special surgery knee score postoperative 1 month
Time frame: postoperative 1 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 3 month
Time frame: postoperative 3 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 6 month
Time frame: postoperative 6 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 12 month
Time frame: postoperative 12 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 24 month
Time frame: postoperative 24 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Hospital for special surgery knee score postoperative 36 month
Time frame: postoperative 36 month
Hospital for special surgery knee score is a knee function scoring system with a full score of 100. 0 means the loss of knee function, 100 means the best knee function, and the greater the value, the better knee function.
Visual Analogue Scale Postoperative Day 1
Time frame: Postoperative Day 1
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 2
Time frame: Postoperative Day 2
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 3
Time frame: Postoperative Day 3
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day 7
Time frame: Postoperative Day 7
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 1 month
Time frame: Postoperative 1 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 3 month
Time frame: Postoperative 3 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 6 month
Time frame: Postoperative 6 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 12 month
Time frame: Postoperative 12 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative Day One
Time frame: Postoperative Day One
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 24 month
Time frame: Postoperative 24month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Visual Analogue Scale Postoperative 36 month
Time frame: Postoperative 36 month
Draw a 10 cm horizontal line on the paper. One end of the line is 0, indicating no pain; the other end is 10, indicating severe pain; and the middle part indicates varying degrees of pain. The patient selects a point from the horizontal line and the length from 0 to this point is the Visual Analogue Scale score.
Evaluation of cartilage repair under MRI postoperative 12 month
Time frame: Postoperative 12 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Evaluation of cartilage repair under MRI postoperative 24 month
Time frame: Postoperative 24 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Evaluation of cartilage repair under MRI postoperative 36 month
Time frame: Postoperative 36 month
Recht criterion was used for grading articular cartilage injury of knee joint, including 0-IV grade, in which: 0 grade, normal articular cartilage, no obvious abnormal signal was found; 1 grade, the layered structure of cartilage disappeared, and there were focal low signal areas, but the surface was smooth; 2 grade, the surface of cartilage was irregular, the depth of cartilage injury was less than 50% cartilage thickness; 3 grade, the surface of cartilage was heavy. The degree of injury is irregular, the depth of injury is more than 50% of the thickness of cartilage or through the whole layer, but the surface of cartilage is not completely exfoliated; Grade IV, full-thickness cartilage defect, articular cartilage injury deep to the cortex, subchondral bone exposed.
Degree of meniscus injury under MRI postoperative 12 month
Time frame: postoperative 12 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Degree of meniscus injury under MRI postoperative 24 month
Time frame: postoperative 24 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Degree of meniscus injury under MRI postoperative 36 month
Time frame: postoperative 36 month
Stoller's criteria were used in the classification of meniscal injuries, including 0-3 grades, in which: 0 grade, the shape of meniscus was regular, complete and even low signal; 1 grade, focal ellipse or circular high signal appeared in the meniscus, which did not extend to the articular surface and margin of the meniscus; 2 grade, the meniscus showed horizontal linear high signal extending to the articular margin of the meniscus. But it did not exceed the articular surface; in grade III, the shape of meniscus was irregular and incomplete. Irregular or linear high signal appeared in the meniscus and extended to the articular surface of meniscus. The grade I and II symptoms of meniscus injury were mild, suggesting meniscus degeneration, and grade III suggesting meniscus tear.
Evaluation of cartilage repair under arthroscope postoperative 12 month
Time frame: postoperative 12 month
The arthroscopic classification of knee joint cartilage injury refers to the classification criteria formulated by the International Association of Cartilage Repair, which includes 0-IV grades, of which: 0 grade is normal articular cartilage; 1 grade is the surface injury of cartilage with soft edema on the surface, with only small cracks and intact structure; 2 grade is partial cartilage injury, which extends downward from the surface, but the depth of injury is less than 50% cartilage thickness. Grade III, deep articular injury, injury depth > 50% cartilage thickness or through the whole layer; Grade IV, deep articular cartilage injury to the bone cortex, full-thickness cartilage defect, subchondral bone exposure.
Degree of meniscus injury under arthroscope postoperative 12 month
Time frame: postoperative 12 month
The degree of meniscus injury under arthroscopy was classified into three grades, including normal, degenerative and tear.
6 secondary outcomes
Squatting to Standing Time postoperative 1 month
Time frame: postoperative 1 month
Squatting to Standing Time postoperative 3 month
Time frame: postoperative 3 month
Squatting to Standing Time postoperative 6 month
Time frame: postoperative 6 month
Squatting to Standing Time postoperative 12 month
Time frame: postoperative 12 month
Squatting to Standing Time postoperative 24 month
Time frame: postoperative 24 month
Squatting to Standing Time postoperative 36 month
Time frame: postoperative 36 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2020.
- Background: PubMed 27606839Yu D, Xu J, Liu F, Wang X, Mao Y, Zhu Z. Subchondral bone changes and the impacts on joint pain and articular cartilage degeneration in osteoarthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):929-934. Epub 2016 Aug 31.
- Background: PubMed 25172825Wilusz RE, Sanchez-Adams J, Guilak F. The structure and function of the pericellular matrix of articular cartilage. Matrix Biol. 2014 Oct;39:25-32. doi: 10.1016/j.matbio.2014.08.009. Epub 2014 Aug 27.
- Background: PubMed 22577397Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.
- Background: PubMed 24162762Chareancholvanich K, Pornrattanamaneewong C, Narkbunnam R. Increased cartilage volume after injection of hyaluronic acid in osteoarthritis knee patients who underwent high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Jun;22(6):1415-23. doi: 10.1007/s00167-013-2735-1. Epub 2013 Oct 27.
- Individual participant dataSharing planned: No. The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
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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.
Peilai Liu, MD study chair
Qilu Hospital of Shandong University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Autologous Adipose-derived Mesenchymal Stem Cell Gel, Sodium Hyaluronate and Extraction of abdominal fat in people with Knee Osteoarthritis and Cartilage Degeneration, run by Qilu Hospital of Shandong University 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 7 inclusion and 8 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 16 Sep 2020. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Songlin Li, MD (0531-82166541, bysonglin@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hospital for special surgery knee score postoperative 1 month (time frame: postoperative 1 month). The study lists 25 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03955497, which also lists 4 linked publications.
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 16 Sep 2020.