NCT03955497

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P50-P75 for phase_1 knee-osteoarthritis

Timeline
Completed

Started Oct 2018

Longer than P75 for phase_1 knee-osteoarthritis

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2018

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

May 14, 2019

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 20, 2019

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2022

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2022

Completed
Last Updated

September 16, 2020

Status Verified

September 1, 2020

Enrollment Period

4 years

First QC Date

May 14, 2019

Last Update Submit

September 15, 2020

Conditions

Knee OsteoarthritisCartilage Degeneration

Keywords

Knee OsteoarthritisStem CellCartilage repair

Outcome Measures

Primary Outcomes (25)

  • 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

  • Hospital for special surgery knee score 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.

    postoperative 12 month

  • Hospital for special surgery knee score 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.

    postoperative 24 month

  • Hospital for special surgery knee score 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.

    postoperative 36 month

  • Visual Analogue Scale 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.

    Postoperative Day 1

  • Visual Analogue Scale 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.

    Postoperative Day 2

  • Visual Analogue Scale 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.

    Postoperative Day 3

  • Visual Analogue Scale 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.

    Postoperative Day 7

  • 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

  • Visual Analogue Scale 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.

    Postoperative 12 month

  • Visual Analogue Scale 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.

    Postoperative Day One

  • Visual Analogue Scale Postoperative 24 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 24month

  • Visual Analogue Scale 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.

    Postoperative 36 month

  • Evaluation of cartilage repair under MRI 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.

    Postoperative 12 month

  • Evaluation of cartilage repair under MRI 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.

    Postoperative 24 month

  • Evaluation of cartilage repair under MRI 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.

    Postoperative 36 month

  • Degree of meniscus injury under MRI 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.

    postoperative 12 month

  • Degree of meniscus injury under MRI 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.

    postoperative 24 month

  • Degree of meniscus injury under MRI 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.

    postoperative 36 month

  • Evaluation of cartilage repair under arthroscope 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.

    postoperative 12 month

  • Degree of meniscus injury under arthroscope postoperative 12 month

    The degree of meniscus injury under arthroscopy was classified into three grades, including normal, degenerative and tear.

    postoperative 12 month

Secondary Outcomes (6)

  • Squatting to Standing Time postoperative 1 month

    postoperative 1 month

  • Squatting to Standing Time postoperative 3 month

    postoperative 3 month

  • Squatting to Standing Time postoperative 6 month

    postoperative 6 month

  • Squatting to Standing Time postoperative 12 month

    postoperative 12 month

  • Squatting to Standing Time postoperative 24 month

    postoperative 24 month

  • +1 more secondary outcomes

Study Arms (2)

Autologous Adipose-derived Mesenchymal Stem Cell Gel

EXPERIMENTAL

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 GelProcedure: Extraction of abdominal fat

sodium hyaluronate

PLACEBO COMPARATOR

The control group received intra-articular injection of sodium hyaluronate one month after operation.

Drug: Sodium Hyaluronate

Interventions

Autologous Adipose-derived Mesenchymal Stem Cell GelOTHER

The experimental group received intra-articular injection of Autologous Adipose-derived Mesenchymal Stem Cell Gel one month after operation.

Autologous Adipose-derived Mesenchymal Stem Cell Gel
Sodium HyaluronateDRUG

The control group received intra-articular injection of sodium hyaluronate one month after operation.

Also known as: hyaluronic acid
sodium hyaluronate
Extraction of abdominal fatPROCEDURE

In the experimental group, abdominal fat was extracted before operation to prepare Autologous Adipose-derived Mesenchymal Stem Cell Gel.

Also known as: Fat extraction
Autologous Adipose-derived Mesenchymal Stem Cell Gel

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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;

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Qilu hospital of Shandong University

Jinan, Shandong, 250012, China

RECRUITING

Related Publications (4)

  • Yu D, Xu J, Liu F, Wang X, Mao Y, Zhu Z. Subchondral bone changes and the impacts on joint pain and articular cartilage degeneration in osteoarthritis. Clin Exp Rheumatol. 2016 Sep-Oct;34(5):929-934. Epub 2016 Aug 31.

    PMID: 27606839BACKGROUND

  • Wilusz RE, Sanchez-Adams J, Guilak F. The structure and function of the pericellular matrix of articular cartilage. Matrix Biol. 2014 Oct;39:25-32. doi: 10.1016/j.matbio.2014.08.009. Epub 2014 Aug 27.

    PMID: 25172825BACKGROUND

  • Baer PC, Geiger H. Adipose-derived mesenchymal stromal/stem cells: tissue localization, characterization, and heterogeneity. Stem Cells Int. 2012;2012:812693. doi: 10.1155/2012/812693. Epub 2012 Apr 12.

    PMID: 22577397BACKGROUND

  • Chareancholvanich K, Pornrattanamaneewong C, Narkbunnam R. Increased cartilage volume after injection of hyaluronic acid in osteoarthritis knee patients who underwent high tibial osteotomy. Knee Surg Sports Traumatol Arthrosc. 2014 Jun;22(6):1415-23. doi: 10.1007/s00167-013-2735-1. Epub 2013 Oct 27.

    PMID: 24162762BACKGROUND

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Hyaluronic Acid

Condition Hierarchy (Ancestors)

OsteoarthritisArthritisJoint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

GlycosaminoglycansPolysaccharidesCarbohydrates

Study Officials

  • Peilai Liu, MD

    Qilu Hospital of Shandong University

    STUDY CHAIR

Central Study Contacts

Songlin Li, MD

CONTACT

0531-82166541bysonglin@126.com

Heran Ma, Ph.D

CONTACT

+86 173645900202523129824@qq.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 14, 2019

First Posted

May 20, 2019

Study Start

October 1, 2018

Primary Completion

October 1, 2022

Study Completion

December 1, 2022

Last Updated

September 16, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

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

Locations

CN(1)