A Phase 1/2 interventional study of Autologous Adipose-derived Mesenchymal Stem Cell Gel and Sodium Hyaluronate in Knee Osteoarthritis and Cartilage Degeneration, sponsored by Qilu Hospital of Shandong University. Status unknown at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2020-09-16.
Sponsored by Qilu Hospital of Shandong University · Phase 1/2, Interventional, and Treatment
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.
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's planned enrollment of 30 is below the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
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Exclusion Criteria:
The 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 · Procedure: Extraction of abdominal fat
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Drug: Sodium Hyaluronate
The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Also known as: hyaluronic acid
In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.
Also known as: Fat extraction
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: postoperative 12 month
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: postoperative 36 month
Plan to share: No — The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.
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Qilu Hospital of Shandong University