Back to resultsThe Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
Primary Purpose
Knee Osteoarthritis
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mesenchymal Stem Cells from adipose
Hyaluronic Acid
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis focused on measuring Knee Osteoarthritis, adipose, mesenchymal stem cells
Eligibility Criteria
Inclusion Criteria:
- K / L score of 2-3;
- chronic knee pain;
- no local or systemic infection;
- without obvious contraindication of the joint puncture from hematology and biochemical tests;
- informed consent.
Exclusion Criteria:
- older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
- HIV, hepatitis virus or syphilis virus infection or their serology is positive;
- BMI index is greater than 30;
- congenital or acquired knee deformity;
- pregnant or lactating women;
- tumor patients;
- immunodeficiency patients;
- intra-articular drug injection history within 3 months;
- participating in other clinical trials;
- other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Mesenchymal Stem Cells from adipose
hyaluronic acid
Arm Description
Mesenchymal Stem Cells from adipose will be injected.
Hyaluronic acid will be injectied.
Outcomes
Primary Outcome Measures
Unexplained local and systemic symptoms or death
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
Secondary Outcome Measures
VAS score
VAS score decrease 3 points or more
WOMAC score
two or more terms of WOMAC score have improvement.
Full Information
NCT ID
NCT03357575
First Posted
November 25, 2017
Last Updated
November 29, 2017
Sponsor
Peking University People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03357575
Brief Title
The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
Official Title
The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid in the Treatment of Adult Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2018 (Anticipated)
Primary Completion Date
June 1, 2020 (Anticipated)
Study Completion Date
December 1, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Peking University People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The aim of this study was to evaluate the efficacy and safety of Mesenchymal Stem Cells (MSCs) from adipose anticular injection in comparison with hyaluronic acid anticular injection in the treatment of human knee osteoarthritis(OA).
Detailed Description
This is a single-centre, quadruple blined, randomized controlled clinical trials with a total of 14 knee osteoarthrits patients as participants, who will be randomly assigned into experiment group or compare group.Participants in experiment group will receive the treatment of MSCs from adipose anticular injection, while participants in compare group will receive hyaluronic acid. Unexplained local and systemic symptoms as well as visual analog scale pain score, WesternOntario McMasterUniversities (WOMAC) Osteoarthritis Index scorewill be assessed at baseline and 2 years after the injection.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Osteoarthritis
Keywords
Knee Osteoarthritis, adipose, mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
14 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Mesenchymal Stem Cells from adipose
Arm Type
Experimental
Arm Description
Mesenchymal Stem Cells from adipose will be injected.
Arm Title
hyaluronic acid
Arm Type
Active Comparator
Arm Description
Hyaluronic acid will be injectied.
Intervention Type
Biological
Intervention Name(s)
Mesenchymal Stem Cells from adipose
Intervention Description
inject mesenchymal Stem Cells from adipose
Intervention Type
Biological
Intervention Name(s)
Hyaluronic Acid
Intervention Description
inject hyaluronic acid
Primary Outcome Measure Information:
Title
Unexplained local and systemic symptoms or death
Description
The severity of AE must be recorded and graded according to the CTCAE criteria, and its relationship to therapy must be assessed according to the following definition:①not related: there is evidence that the cause of adverse events is not due to intra-articular injection therapy (such as previous conditions, potential diseases, concurrent diseases); ②related: AE and intra-articular injection are time-related and it is known or suspected that intra-articular injection of drugs can cause the AE; ③it can't be assessed.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
VAS score
Description
VAS score decrease 3 points or more
Time Frame
2 years
Title
WOMAC score
Description
two or more terms of WOMAC score have improvement.
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
K / L score of 2-3;
chronic knee pain;
no local or systemic infection;
without obvious contraindication of the joint puncture from hematology and biochemical tests;
informed consent.
Exclusion Criteria:
older than 75 years old or less than 18 years old, or without full capacity for civil conduct;
HIV, hepatitis virus or syphilis virus infection or their serology is positive;
BMI index is greater than 30;
congenital or acquired knee deformity;
pregnant or lactating women;
tumor patients;
immunodeficiency patients;
intra-articular drug injection history within 3 months;
participating in other clinical trials;
other patients who researchers believe are not eligible for inclusion such as suffering from other concomitant diseases.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ziyi Yang, MD
Phone
18810335110
Email
bjmuyangziyi@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ziyi Yang
Organizational Affiliation
arthritis clinic and research center
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
The Comparison of Efficacy and Safety of the Mesenchymal Stem Cells From Adipose and Hyaluronic Acid
We'll reach out to this number within 24 hrs