Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis
Primary Purpose
Knee Osteoarthritis
Status
Completed
Phase
Phase 1
Locations
Taiwan
Study Type
Interventional
Intervention
GXCPC1
HA
Sponsored by
About this trial
This is an interventional treatment trial for Knee Osteoarthritis
Eligibility Criteria
Inclusion Criteria:
- Provision of signed and dated informed consent form
- Aged 40 to 80 years old (inclusive)
- Kellgren-Lawrence grading II-IV, as determined by American College ofRheumatology (ACR) criteria for osteoarthritis of the knee
- Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7 ~ 17 (inclusive) in the target knee despite use of NSAID
- Contraindicated to long term systemic NSAID (e.g. suffer from severe gastrointestinal side effects upon systemic NSAID administration, or due to underlying increased gastrointestinal, cardiovascular, or renal risk) and not able to receive or wish to delay knee arthroplasty
Exclusion Criteria:
- With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
- With previous intra-articular intervention (e.g. steroid, anesthetics, hyaluronate, arthroscopic surgery) on the target knee joint 12 weeks prior to screening
- Administered or required systemic or local on the target knee joint immunosuppressive agent, anti-inflammatory drug, steroid, analgesics, opioid, or duloxetine for OA knee except for acetaminophen and NSAID within 1 week prior to screening
- With joint diseases other than knee osteoarthritis considered by investigator not eligible to enter the study
- Unable to receive MRI examination, including allergic to the contrast medium for MRI used in the study, with known history of claustrophobia, having any existing metallic intraocular foreign body or active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator
- Active or suspected infection of the target knee joint
- History of human immunodeficiency virus (HIV) infection
- History of malignancy within 2 years prior to screening
- With body mass index (BMI) greater or equal to 35 kg/m2
- Known hypersensitivity to any component of the investigational product or the active control
- Participated other investigational study within 4 weeks prior to screening
- With ongoing or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Screening
Subject with childbearing potential refuses to use highly effective contraceptives from signing informed consent until Final/Early Termination Visit. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
- Established use of oral, injected or implanted hormonal methods of contraception
- Placement of an intrauterine device (IUD) or intrauterine system (IUS)
- Barrier methods of contraception: condom, or occlusive cap (diaphragmor cervical/vault caps)
Sites / Locations
- GWOXI Stem Cell Applied Technology Co., Ltd.
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
GXCPC1
hyaluronic acid
Arm Description
GXCPC1 contains 6.7×10^6 or 4×10^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL
Hya Joint Plus synovial fluid supplement 3mL
Outcomes
Primary Outcome Measures
WOMAC pain score
Change from baseline in WOMAC pain score at Week 24
Secondary Outcome Measures
MRI
Change from baseline to post-treatment visits on the target knee in MRI examination results
Visual Analogue Scale (VAS)
Changes from baseline to post-treatment visits on the target knee in Visual Analogue Scale (VAS) for pain
12-item Short Form (SF-12)
Change from baseline to post-treatment visits in total score of 12-item Short Form (SF-12) health survey questionnaire
Full Information
NCT ID
NCT03943576
First Posted
January 23, 2019
Last Updated
June 5, 2023
Sponsor
Gwo Xi Stem Cell Applied Technology Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT03943576
Brief Title
Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis
Official Title
Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
December 1, 2019 (Actual)
Primary Completion Date
April 27, 2022 (Actual)
Study Completion Date
March 22, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gwo Xi Stem Cell Applied Technology Co., 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
The aim of the investigators study was to investigate the safety and efficacy of allogeneic ADSCs for the clinical treatment of 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 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
GXCPC1
Arm Type
Experimental
Arm Description
GXCPC1 contains 6.7×10^6 or 4×10^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL
Arm Title
hyaluronic acid
Arm Type
Active Comparator
Arm Description
Hya Joint Plus synovial fluid supplement 3mL
Intervention Type
Drug
Intervention Name(s)
GXCPC1
Intervention Description
The dose regimen is one single intra-articular injection of GXCPC1 containing 6.7×10^6 or 4×10^7 ADSCs in 3 mL saline. (allogeneic injection)
Intervention Type
Device
Intervention Name(s)
HA
Intervention Description
Hya Joint Plus synovial fluid supplement 3mL
Primary Outcome Measure Information:
Title
WOMAC pain score
Description
Change from baseline in WOMAC pain score at Week 24
Time Frame
week 24
Secondary Outcome Measure Information:
Title
MRI
Description
Change from baseline to post-treatment visits on the target knee in MRI examination results
Time Frame
week 0, 24, 48
Title
Visual Analogue Scale (VAS)
Description
Changes from baseline to post-treatment visits on the target knee in Visual Analogue Scale (VAS) for pain
Time Frame
week 0, 1, 4, 12, 24
Title
12-item Short Form (SF-12)
Description
Change from baseline to post-treatment visits in total score of 12-item Short Form (SF-12) health survey questionnaire
Time Frame
week 0, 1, 4, 12, 24
10. Eligibility
Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Provision of signed and dated informed consent form
Aged 40 to 80 years old (inclusive)
Kellgren-Lawrence grading II-IV, as determined by American College ofRheumatology (ACR) criteria for osteoarthritis of the knee
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) pain score of 7 ~ 17 (inclusive) in the target knee despite use of NSAID
Contraindicated to long term systemic NSAID (e.g. suffer from severe gastrointestinal side effects upon systemic NSAID administration, or due to underlying increased gastrointestinal, cardiovascular, or renal risk) and not able to receive or wish to delay knee arthroplasty
Exclusion Criteria:
With previous surgery of articular fracture, ligament reconstruction, meniscal reconstruction, and knee arthroplasty on the target knee joint
With previous intra-articular intervention (e.g. steroid, anesthetics, hyaluronate, arthroscopic surgery) on the target knee joint 12 weeks prior to screening
Administered or required systemic or local on the target knee joint immunosuppressive agent, anti-inflammatory drug, steroid, analgesics, opioid, or duloxetine for OA knee except for acetaminophen and NSAID within 1 week prior to screening
With joint diseases other than knee osteoarthritis considered by investigator not eligible to enter the study
Unable to receive MRI examination, including allergic to the contrast medium for MRI used in the study, with known history of claustrophobia, having any existing metallic intraocular foreign body or active/inactive implanted medical devices, such as cardiac pacemaker, cochlear, intracranial vascular clips or neurostimulator
Active or suspected infection of the target knee joint
History of human immunodeficiency virus (HIV) infection
History of malignancy within 2 years prior to screening
With body mass index (BMI) greater or equal to 35 kg/m2
Known hypersensitivity to any component of the investigational product or the active control
Participated other investigational study within 4 weeks prior to screening
With ongoing or within the past 2 years serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigators' opinion could interfere with the results of the trial or adversely affect the safety of the subject
Female subject with childbearing potential who is lactating or has positive serum or urine pregnancy test at Screening
Subject with childbearing potential refuses to use highly effective contraceptives from signing informed consent until Final/Early Termination Visit. At least two forms of birth control must be adopted and one of which must be a barrier method. Acceptable forms include:
Established use of oral, injected or implanted hormonal methods of contraception
Placement of an intrauterine device (IUD) or intrauterine system (IUS)
Barrier methods of contraception: condom, or occlusive cap (diaphragmor cervical/vault caps)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheng-FONG Chen
Organizational Affiliation
Taipei Veterans General Hospital, Taiwan
Official's Role
Principal Investigator
Facility Information:
Facility Name
GWOXI Stem Cell Applied Technology Co., Ltd.
City
Hsinchu
ZIP/Postal Code
30261
Country
Taiwan
12. IPD Sharing Statement
Learn more about this trial
Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis
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