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

Primary Purpose

Knee Osteoarthritis

Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Auotologous AMSCs plus autologous PRP
Auotologous PRP
Sponsored by
Yantai Yuhuangding Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray.
  2. Subject's pain score is 8-13 points (Lequesne's index).
  3. Ages between 40-70 years.
  4. Signed informed consent from the subject.

Exclusion Criteria:

  1. Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV
  2. Subject not suitable for liposuction surgery.
  3. Subject with hypersensitivity/allergy to anesthetic.
  4. Subject's creatinine values higher than 1.6mg/dl.
  5. Subject with body mass index, BMI over 30.
  6. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen.
  7. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery.
  8. Subject enrolled in any other cell therapy studies within the past 30 days.
  9. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above.
  10. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint.
  11. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.

Sites / Locations

  • Yantai Yuhuangding HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

AMSCs plus PRP group

PRP group

Arm Description

Three intra-articular injections in total and autologous adipose-derived mesenchymal stem cells (AMSCs) suspended in 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.

Three intra-articular injections in total and 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.

Outcomes

Primary Outcome Measures

Physical function change
Evaluation the physical function change measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Change in pain density
Evaluation the changing of pain density measured by Visual Analogue Scale. 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.

Secondary Outcome Measures

Cartilage repair
Evaluation of cartilage repair under MRI. 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.
Change in MOS item short from health survey(SF-36)
Evaluation of the health-related quality of life change Measured by MOS item short from health survey(SF-36) after each cell injection. SF-36 is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Change in Lequesne Index
Evaluation of severity of knee symptoms Lequesne Index includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function
Change in knee society score (KSS)
The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.Higher scores indicate better knee score/satisfaction/functioning or higher expectations.

Full Information

First Posted
December 26, 2019
Last Updated
March 26, 2023
Sponsor
Yantai Yuhuangding Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04212728
Brief Title
Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Official Title
Treatment of Knee Osteoarthritis With Autologous Adipose-derived Mesenchymal Stem Cells
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 29, 2019 (Actual)
Primary Completion Date
December 2023 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Yantai Yuhuangding Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to explore the efficacy and safety of autologous adipose-derived mesenchymal stem cells (AMSCs) plus autologous platelet rich plasma (PRP) in the treatment of severe knee osteoarthritis.
Detailed Description
This is a single centered, randomized, single blind phase II clinical study. Patients will be divided into two groups of case and control. Patients of case group will receive intra-articular injection of autologous AMSCs suspended in 3 ml autologous PRP for 3 times, patients of control group will receive intra-articular injection of 3 ml of autologous PRP for 3 times. The investigators designed this clinical study to evaluate therapeutic effects of AMSCs in patients with severe knee osteoarthritis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
AMSCs plus PRP group
Arm Type
Experimental
Arm Description
Three intra-articular injections in total and autologous adipose-derived mesenchymal stem cells (AMSCs) suspended in 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Arm Title
PRP group
Arm Type
Active Comparator
Arm Description
Three intra-articular injections in total and 3 ml autologous platelet rich plasma (PRP) for each injection. Time-points for intervention: 1) initial injection; 2) 3 months following initial injection; 3) 6 months following initial injection.
Intervention Type
Biological
Intervention Name(s)
Auotologous AMSCs plus autologous PRP
Intervention Description
150 mL subcutaneous abdominal adipose tissue will be harvested via liposuction . AMSCs will be isolated and cultured from adipose tissue. Before injection, 30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.Cultured AMSCs will be collected and suspended by 3ml autologous PRP.
Intervention Type
Biological
Intervention Name(s)
Auotologous PRP
Intervention Description
30 mL of blood will be collected from each patient to produce 3ml PRP by cenrifugation.
Primary Outcome Measure Information:
Title
Physical function change
Description
Evaluation the physical function change measured by the Western Ontario and McMaster Universities Arthritis Index (WOMAC). The WOMAC consists of three subscales: pain (five questions), stiffness (two questions), and physical function (17 questions). The subscale scores can vary, with pain ranging from 0 to 20 points; stiffness, 0 to 8 points; and physical function, 0 to 68 points. Higher scores represent worse pain, stiffness, and functional limitations.
Time Frame
From before randomization until 3, 6, and 12 months after treatment start.
Title
Change in pain density
Description
Evaluation the changing of pain density measured by Visual Analogue Scale. 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
From before randomization until 3, 6, and 12 months after treatment start.
Secondary Outcome Measure Information:
Title
Cartilage repair
Description
Evaluation of cartilage repair under MRI. 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
From before randomization until 3, 6, and 12 months after treatment start.
Title
Change in MOS item short from health survey(SF-36)
Description
Evaluation of the health-related quality of life change Measured by MOS item short from health survey(SF-36) after each cell injection. SF-36 is a self-administered questionnaire comprising 36-items measuring eight dimensions of general HRQOL: physical functioning (10 items), role limitation due to physical health problems (4 items), bodily pain (2 items), general health perceptions (5 items), vitality (4 items), social functioning (2 items), role limitations due to emotional problems (3 items), and general mental health (5 items).These outcomes will be grouped as physical component summary and mental component summary. The norm data is 0-100, the health related quality of life is increases as the scores are increased. The average score is 50.
Time Frame
From before randomization until 3, 6, and 12 months after treatment start.
Title
Change in Lequesne Index
Description
Evaluation of severity of knee symptoms Lequesne Index includes the measurement of pain (5 items), walking distance (2 items), and activities of daily living (4 items). Maximal score is 24 and higher scores represent worse function
Time Frame
From before randomization until 3, 6, and 12 months after treatment start.
Title
Change in knee society score (KSS)
Description
The knee society score is divided into four parts: it consists of the ''Symptoms''(25 points), the ''Patient satisfaction''(40 points), the ''Patient expectation''(15 points) and the ''Functional activities''(100 points). Each part will be evaluated separately.Higher scores indicate better knee score/satisfaction/functioning or higher expectations.
Time Frame
From before randomization until 3, 6, and 12 months after treatment start.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subject has Kellgren and Lawrence grade II-IV primary osteoarthritis as determined by X-ray. Subject's pain score is 8-13 points (Lequesne's index). Ages between 40-70 years. Signed informed consent from the subject. Exclusion Criteria: Subject infected with hepatitis B, hepatitis C, HIV, syphilis or HTLV Subject not suitable for liposuction surgery. Subject with hypersensitivity/allergy to anesthetic. Subject's creatinine values higher than 1.6mg/dl. Subject with body mass index, BMI over 30. Subject's studied knee treated with intra-articular injection therapy within 6 months prior to screen. Subject has undergone surgery on studied knee, including fracture surgery, arthroscopic surgery, meniscus repair surgery, or cruciate ligament reconstruction surgery. Subject enrolled in any other cell therapy studies within the past 30 days. Subject who the investigator considers inappropriate for the clinical trial due to any other reasons than those listed above. Subject has a history of gouty arthritis, septic arthritis, rheumatoid arthritis and any other autoimmune arthritis of the knee joint. Subject has had major medical problems in vital organs, such as; heart, liver, kidney, or lung.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Peiwen Lian, PhD
Phone
+0086 5356691999
Ext
81511
Email
peiwen.lian@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jian Chen, PhD
Phone
+0086 5356691999
Ext
82708
Email
chenjianyt@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peiwen Lian, PhD
Organizational Affiliation
Yantai Yuhuangding Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Yantai Yuhuangding Hospital
City
Yantai
State/Province
Shandong
ZIP/Postal Code
264000
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peiwen Lian, PhD
Phone
+0086 5356691999
Ext
82708
Email
peiwen.lian@hotmail.com

12. IPD Sharing Statement

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

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