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

September 15, 2020 updated by: Qilu Hospital of Shandong University

Efficacy and Safety of Autologous Adipose-derived Mesenchymal Stem Cells in the Treatment of Early Knee Osteoarthritis

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

8

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Shandong
      • Jinan, Shandong, China, 250000
        • Qilu Hospital of Shandong University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 65 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 1 month
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.
postoperative 3 month
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.
postoperative 6 month
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.
Postoperative 1 month
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.
Postoperative 3 month
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.
Postoperative 6 month
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.
postoperative 1 month
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.
postoperative 3 month
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.
postoperative 6 month
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.
postoperative 3 month
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.
postoperative 6 month
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.
postoperative 3 month
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.
postoperative 6 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
postoperative 1 month
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.
postoperative 3 month
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.
postoperative 6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Hospital of Shandong University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 2, 2019

Primary Completion (Actual)

September 9, 2020

Study Completion (Anticipated)

November 1, 2020

Study Registration Dates

First Submitted

May 16, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (Actual)

May 21, 2019

Study Record Updates

Last Update Posted (Actual)

September 16, 2020

Last Update Submitted That Met QC Criteria

September 15, 2020

Last Verified

September 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2019042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

The acquisition of individual participant data needs the consent of Peilai Liu, the person in charge.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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