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

Study Overview
=================
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.

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.

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

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Drug: Autologous adipose-derived mesenchymal stem cells
* Procedure: abdominal liposuction


Participation Criteria
=================
Eligibility 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.

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 65 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Autologous adipose-derived mesenchymal stem cells<br>Patients receiving intra-articular injection of autologous adipose-derived mesenchymal stem cells | Drug: Autologous adipose-derived mesenchymal stem cells<br>* 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.<br>Procedure: abdominal liposuction<br>* 50 ml abdominal fat was extracted by abdominal liposuction to prepare autologous adipose-derived mesenchymal stem cells<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | postoperative 6 month | 
| 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. | 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. | 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. | Postoperative 6 month | 
| Evaluation of cartilage repair under MRI 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 | 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 | 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 | 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 | 
| 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. | 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. | 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. | postoperative 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction of patients 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 | 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 | 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 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autologous adipose-derived mesenchymal stem cells, Knee Osteoarthritis