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Trial record 15 of 99 for:    stem cell arthritis AND Mesenchymal

Treatment of Early Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells

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ClinicalTrials.gov Identifier: NCT03956719
Recruitment Status : Recruiting
First Posted : May 21, 2019
Last Update Posted : August 30, 2019
Sponsor:
Information provided by (Responsible Party):
Qilu Hospital of Shandong University

Brief Summary:
The purpose of this study is to explore the efficacy and safety of autologous adipose mesenchymal stem cells in the treatment of early knee arthritis. Investigator believes that autologous adipose mesenchymal stem cells can relieve pain, improve knee function, promote knee cartilage regeneration and improve life satisfaction of patients.

Condition or disease Intervention/treatment Phase
Knee Osteoarthritis Drug: Autologous adipose-derived mesenchymal stem cells Procedure: abdominal liposuction Not Applicable

Detailed Description:
Investigators extracted abdominal fat from eight patients, extracted autologous adipose mesenchymal stem cells and injected them into the knee joint of the patients. The data were followed up regularly after operation and compared with those before operation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Early Knee Osteoarthritis
Actual Study Start Date : March 2, 2019
Estimated Primary Completion Date : September 2, 2019
Estimated Study Completion Date : September 2, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis

Arm Intervention/treatment
Experimental: Autologous adipose-derived mesenchymal stem cells
Patients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells
Drug: Autologous adipose-derived mesenchymal stem cells
Autologous adipose-derived mesenchymal stem cells is extracted from human abdominal fat, which is crushed, filtered and immediately returned to the articular cavity through a specific device.

Procedure: abdominal liposuction
50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells




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. 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.

  5. 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.

  6. 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.

  7. Evaluation of cartilage repair under MRI postoperative 3 month [ Time Frame: postoperative 3 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.

  8. Evaluation of cartilage repair under MRI postoperative 6 month [ Time Frame: postoperative 6 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.

  9. Degree of meniscus injury under MRI postoperative 3 month [ Time Frame: postoperative 3 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.


  10. Degree of meniscus injury under MRI postoperative 6 month [ Time Frame: postoperative 6 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.


  11. 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.

  12. 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.

  13. 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.


Secondary Outcome Measures :
  1. Satisfaction of patients postoperative 1 month [ Time Frame: postoperative 1 month ]
    The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.

  2. Satisfaction of patients postoperative 3 month [ Time Frame: postoperative 3 month ]
    The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.

  3. Satisfaction of patients postoperative 6 month [ Time Frame: postoperative 6 month ]
    The satisfaction degree of patients with treatment effect, full score of 10 points, 1 represents not satisfied at all, 10 represents very satisfied.



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Ages Eligible for Study:   15 Years to 65 Years   (Child, 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 early stage degenerative arthritis by Radiographic Criteria and physical examination;
  • Obviously extra-articular malformation;
  • Course of disease ≥ six months;
  • No medication for knee osteoarthritis in the past three months
  • 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): NCT03956719


Contacts
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Contact: Songlin Li, MD 15634057227 bysonglin@126.com

Locations
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China, Shandong
Qilu hospital of Shandong University Recruiting
Jinan, Shandong, China, 250000
Contact: Peiali Liu, MD    0531-82166540    15634057227@163.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: NCT03956719     History of Changes
Other Study ID Numbers: 2019042
First Posted: May 21, 2019    Key Record Dates
Last Update Posted: August 30, 2019
Last Verified: March 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:
Autologous adipose-derived mesenchymal stem cells
Knee Osteoarthritis
Additional relevant MeSH terms:
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Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases