search
Back to results

Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis

Primary Purpose

Knee Osteoarthritis

Status
Not yet recruiting
Phase
Phase 3
Locations
China
Study Type
Interventional
Intervention
Mesenchymal progenitor cells
Sodium Hyaluronate Injection
Sponsored by
Cellular Biomedicine Group Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Knee Osteoarthritis

Eligibility Criteria

40 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Subjects who understand and voluntarily sign the consent form before this study; According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed; Age: 40-75, males and females; The course of knee osteoarthritis was more than 6 months; The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC score at least 48 hours after discontinuation of all painkillers); The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III; Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches. Exclusion Criteria: The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on). The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells. The subject has a BMI of over 30. Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L, platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upper limit of 1.2 times normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase > upper limit of 2 times of normal value range. The subject has diseases or symptoms may affect VAS, WOMAC and so on. The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers. The subject has an history malignant tumour. The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis. The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial. According to the researchers, the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on. The subject had any other coagulation dysfunction caused by acute or chronic diseases, according to the judgment of the researchers, this coagulation dysfunction may endanger the safety of patients and / or affect the judgment of knee joint evaluation indicators. The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial. The subject has received other intra-articular injections, including but not limited to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic glucose and so on for KOA in the 3 months preceding the trial. The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment. The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment. The subject has attenuated or live attenuated vaccine injection with 1 month before the treatment. The subject has undergone knee prosthesis or a plan of knee prosthesis within the trial. The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on. The subject tests positive for: HIV, HBV, HCV and treponema pallidum. The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial. The subject has participated in any other clinical trial in the 3 months prior to this trial. The subject (including male subjects) has fertility, sperm donation or egg donation plans during the trial period; the female subject is pregnant, lactating or having a positive pregnancy test. The subject is legally disabled by reference to the law of the people's Republic of China on the protection of disabled persons (April 2008). The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator. The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.

Sites / Locations

  • Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
  • China-Japan Friendship Hospital
  • The Second Affiliated hospital of Zhejiang University School of Medicine
  • Huashan Hospital Affiliated to Fudan University
  • Shanghai General Hospital
  • Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Mesenchymal progenitor cells

Sodium hyaluronate

Arm Description

Mesenchymal progenitor cells group

Sodium hyaluronate injection group

Outcomes

Primary Outcome Measures

WOMAC score
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome,will be tested at 24 weeks after the first injection

Secondary Outcome Measures

MRI quantitative analysis of articular cartilage
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 48 weeks after the first injection
WOMAC Score
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
VAS Score
Visual Analogue Scale/Score;0-10 points;10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
SF-36
The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points;100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
MRI quantitative analysis of articular cartilage
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24 and 96 weeks after the first injection
Whole-Organ Magnetic Resonance Imaging Score
Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 24、48 and 96 weeks
mJSW
Minimum joint space width (mJSW) of the knee, will be measured at baseline and 96 weeks
Adverse Events and Serious Adverse Events
AE and SAE, will be assessed within the 96 week time span
Physical examination
Height and weight will be tested and combined to report BMI in kg/m^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、96

Full Information

First Posted
May 8, 2023
Last Updated
August 9, 2023
Sponsor
Cellular Biomedicine Group Ltd.
search

1. Study Identification

Unique Protocol Identification Number
NCT05996224
Brief Title
Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis
Official Title
A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for Knee Osteoarthritis.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
October 2023 (Anticipated)
Primary Completion Date
December 2025 (Anticipated)
Study Completion Date
December 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cellular Biomedicine Group Ltd.

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
Evaluate the efficacy and safety of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells Therapy
Detailed Description
A Multicenter, Randomized, Double-blind, Controlled Phase III Trial of Allogenic Adipose Tissue-Derived Mesenchymal Progenitor Cells (AlloJoin®) Therapy for 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
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
488 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Mesenchymal progenitor cells
Arm Type
Experimental
Arm Description
Mesenchymal progenitor cells group
Arm Title
Sodium hyaluronate
Arm Type
Active Comparator
Arm Description
Sodium hyaluronate injection group
Intervention Type
Biological
Intervention Name(s)
Mesenchymal progenitor cells
Intervention Description
Allogenic Adipose tissue-derived mesenchymal progenitor cells administrated for intra- articular use
Intervention Type
Drug
Intervention Name(s)
Sodium Hyaluronate Injection
Other Intervention Name(s)
Hyaluronic acid injection
Intervention Description
Sodium Hyaluronate administrated for intra-articular use
Primary Outcome Measure Information:
Title
WOMAC score
Description
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome,will be tested at 24 weeks after the first injection
Time Frame
24 weeks
Secondary Outcome Measure Information:
Title
MRI quantitative analysis of articular cartilage
Description
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 48 weeks after the first injection
Time Frame
48 weeks
Title
WOMAC Score
Description
The Western Ontario and McMaster Universities Osteoarthritis Index;0-96 points;96 points mean a worse outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
Time Frame
4、12、24、36、48、60、72、84、96 weeks
Title
VAS Score
Description
Visual Analogue Scale/Score;0-10 points;10 points mean the worse outcome,will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
Time Frame
4、12、24、36、48、60、72、84、96 weeks
Title
SF-36
Description
The Medical Outcomes Study 36-Item Short-Form Health Survey;0-100 points;100 points mean a better outcome, will be tested at 4、12、24、36、48、60、72、84 and 96 weeks after the first injection
Time Frame
4、12、24、36、48、60、72、84、96 weeks
Title
MRI quantitative analysis of articular cartilage
Description
Magnetic Resonance Imaging analysis of articular cartilage, will be tested at 24 and 96 weeks after the first injection
Time Frame
24 weeks and 96 weeks
Title
Whole-Organ Magnetic Resonance Imaging Score
Description
Whole-Organ Magnetic Resonance Imaging Score(WORMS) of the knee; 0-332points; 332 points means the worst outcome; will be assessed at 24、48 and 96 weeks
Time Frame
24、48 and 96 weeks
Title
mJSW
Description
Minimum joint space width (mJSW) of the knee, will be measured at baseline and 96 weeks
Time Frame
96 weeks
Title
Adverse Events and Serious Adverse Events
Description
AE and SAE, will be assessed within the 96 week time span
Time Frame
Day 0 to 96 weeks
Title
Physical examination
Description
Height and weight will be tested and combined to report BMI in kg/m^2at Day 0 and week 1、2、3、4、12、24、36、48、60、72、84、96
Time Frame
Day 0、week 1、2、3、4、12、24、36、48、60、72、84、96
Other Pre-specified Outcome Measures:
Title
Inflammatory biomarkers detection
Description
Prostaglandin E2 in serum will be tested at Day 0 and week 4、12、24、36、48、96
Time Frame
Day 0 and week 4、12、24、36、48、96

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Subjects who understand and voluntarily sign the consent form before this study; According to the diagnostic criteria (American Rheumatology Association, clinical + radiology criteria), patients with knee osteoarthritis are definitely diagnosed; Age: 40-75, males and females; The course of knee osteoarthritis was more than 6 months; The subjects' WOMAC score was 24-72, and the WOMAC pain score was 7-17 (the WOMAC score at least 48 hours after discontinuation of all painkillers); The Kellgren Lawrence grade (X-ray axial position of knee joint) of subjects was grade II / III; Subjects are generally in good condition and can walk autonomously, except for those who use wheelchairs, walking aids or crutches. Exclusion Criteria: The subject may be allergic to the main cell preparation components (B vitamins, amino acids and so on). The subject received systemic and / or local treatment with autologous and / or allogeneic mesenchymal progenitor cells. The subject has a BMI of over 30. Laboratory test (any item meets): neutrophil absolute number < 1.0 × 10^9 / L, platelet count < 50 × 10^9 / L, serum albumin < 30g / L, serum creatinine > upper limit of 1.2 times normal value range, total bilirubin、alanine aminotransferase、aspartate aminotransferase > upper limit of 2 times of normal value range. The subject has diseases or symptoms may affect VAS, WOMAC and so on. The subject has serious and poorly controlled concomitant diseases, such as (but not limited to) nervous system, cardiovascular, liver, kidney, gastrointestinal and endocrine diseases, which may prevent the subjects from participating in the study according to the judgment of the researchers. The subject has an history malignant tumour. The subject has connective tissue disease or rheumatoid arthritis、chondropathy、Chondrocalcinosis articularis、 Hemochromatosis、inflammatory arthropathy、avascular necrosis of femoral head、Paget's disease、hemophilic arthropathy、infectional arthritis、Charcot' s disease、villonodular synovitis or synovial chondromatosis. The subject has severe generalized infectious diseases or local knee infection (including skin and intra-articular infection) in the 3 months prior to this trial. According to the researchers, the subject has disease of lower limbs which may be interfered knee evaluation, for example fibromyalgia, osphyalgia, lumbar disc protrusion and so on. The subject had any other coagulation dysfunction caused by acute or chronic diseases, according to the judgment of the researchers, this coagulation dysfunction may endanger the safety of patients and / or affect the judgment of knee joint evaluation indicators. The subject has received arthroscopic surgery or other open surgery related to knee joint operation in the 6 months prior to this trial. The subject has received other intra-articular injections, including but not limited to hyaluronic acid, hormone, PRP, BMP (bone morphogenetic protein) , hypertonic glucose and so on for KOA in the 3 months preceding the trial. The subject has received aminoglucose or chondroitin sulfate within 1 month before the treatment. The subject has used dexamethasone, prednisone, hydrocortisone and other hormones orally / intravenously within 1 month before the treatment. The subject has attenuated or live attenuated vaccine injection with 1 month before the treatment. The subject has undergone knee prosthesis or a plan of knee prosthesis within the trial. The subject has contraindication of MRI, included but not only: the subject installed heart pacemaker, defibrillator, heart bracket, heart valve prosthesis, metal clip after aneurysm surgery, drug infusion device implanted in vivo, any electronic device implanted in the body (nerve stimulator, bone growth stimulator) endovascular coil, strainer, ECG monitor, metal suture, shrapnel or sand of body, plate fixation and steel nail after fracture surgery, artificial cochlea, middle ear shift plant, metallic intraocular foreign body etc; the subject is a claustrophobia, critical ill patient and so on. The subject tests positive for: HIV, HBV, HCV and treponema pallidum. The subject has history of alcoholism, drug abuse, or mental illness in the 3 years prior to this trial. The subject has participated in any other clinical trial in the 3 months prior to this trial. The subject (including male subjects) has fertility, sperm donation or egg donation plans during the trial period; the female subject is pregnant, lactating or having a positive pregnancy test. The subject is legally disabled by reference to the law of the people's Republic of China on the protection of disabled persons (April 2008). The subject has any other unsuitable condition (such as factors reducing the follow-up compliance) to be determined by the investigator. The Kellgren Lawrence grade (X-ray axial position of knee joint) of any knee joint of the subjects was grade IV.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Chunde Bao, M.D. & Ph.D.
Phone
M.D. & Ph.D.
Email
xck@renji.com
Facility Information:
Facility Name
Department of Rheumatology,Ren Ji Hospital,School of Medicine,Shanghai Jiao Tong University,Shanghai,China
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Facility Name
China-Japan Friendship Hospital
City
Beijing
ZIP/Postal Code
100029
Country
China
Facility Name
The Second Affiliated hospital of Zhejiang University School of Medicine
City
Hangzhou
ZIP/Postal Code
310009
Country
China
Facility Name
Huashan Hospital Affiliated to Fudan University
City
Shanghai
ZIP/Postal Code
200040
Country
China
Facility Name
Shanghai General Hospital
City
Shanghai
ZIP/Postal Code
200080
Country
China
Facility Name
Shanghai Ninth People's Hospital, Shanghai JiaoTong University School of Medicine
City
Shanghai
Country
China

12. IPD Sharing Statement

Learn more about this trial

Allogenic Adipose-Derived Mesenchymal Progenitor Cells for the Treatment of Knee Osteoarthritis

We'll reach out to this number within 24 hrs