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Effectiveness of Autologous Adipose-derived Stem Cells in the Treatment of Knee Cartilage Injury

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ClinicalTrials.gov Identifier: NCT03955497
Recruitment Status : Recruiting
First Posted : May 20, 2019
Last Update Posted : May 20, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Brief 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. Investigator believe that this method will enable patients to recover better knee function and more repair of knee cartilage.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Cartilage Degeneration Other: Autologous Adipose-derived Mesenchymal Stem Cell Gel Drug: Sodium Hyaluronate Procedure: Extraction of abdominal fat Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy and Safety Research of Autologous Adipose-derived Mesenchymal Stem Cell Gel in the Treatment of Cartilage Damage in the Knee
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : December 1, 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Autologous Adipose-derived Mesenchymal Stem Cell Gel
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
The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.

Procedure: Extraction of abdominal fat
In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.
Other Name: Fat extraction

Placebo Comparator: sodium hyaluronate
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Drug: Sodium Hyaluronate
The control group received intra-articular injection of sodium hyaluronate one month after operation.
Other Name: hyaluronic acid




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.

  11. 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.

  12. 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.

  13. 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.

  14. 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.

  15. 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.

  16. 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.

  17. 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.

  18. 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.

  19. 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.

  20. 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.

  21. 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.


  22. 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.


  23. 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.


  24. 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.

  25. 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.


Secondary Outcome Measures :
  1. Squatting to Standing Time postoperative 1 month [ Time Frame: postoperative 1 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

  2. Squatting to Standing Time postoperative 3 month [ Time Frame: postoperative 3 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

  3. Squatting to Standing Time postoperative 6 month [ Time Frame: postoperative 6 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

  4. Squatting to Standing Time postoperative 12 month [ Time Frame: postoperative 12 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

  5. Squatting to Standing Time postoperative 24 month [ Time Frame: postoperative 24 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.

  6. Squatting to Standing Time postoperative 36 month [ Time Frame: postoperative 36 month ]
    The patient squatted on the floor and then stood up completely for five consecutive times, recording the time required.



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955497


Contacts
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Contact: Songlin Li, MD 0531-82166541 984319829@qq.com
Contact: Heran Ma, Ph.D +86 17364590020 2523129824@qq.com

Locations
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China, Shandong
Qilu hospital of Shandong University Recruiting
Jinan, Shandong, China, 250012
Contact: Songlin Li, MD    053182166541    984319829@qq.com   
Contact: Heran Ma, Ph.D    +8617364590020    2523129824@qq.com   
Sponsors and Collaborators
Qilu Hospital of Shandong University
Investigators
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Study Chair: Peilai Liu, MD Qilu Hospital of Shandong University

Publications:
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Responsible Party: Qilu Hospital of Shandong University
ClinicalTrials.gov Identifier: NCT03955497     History of Changes
Other Study ID Numbers: 2018023
First Posted: May 20, 2019    Key Record Dates
Last Update Posted: May 20, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Qilu Hospital of Shandong University:
Knee Osteoarthritis
Stem Cell
Cartilage repair

Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Hyaluronic Acid
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Viscosupplements
Protective Agents