Knee OsteoarthritisPhase 1/2NCT03943576
Allogeneic Adipose Tissue-Derived Mesenchymal Stem Cells (GXCPC1) for Knee Osteoarthritis
A Phase 1/2 study testing GXCPC1 and HA in people with Knee Osteoarthritis, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 1 site in Taiwan.
Trial summary
The aim of the investigators study was to investigate the safety and efficacy of allogeneic ADSCs for the clinical treatment of knee osteoarthritis. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Knee Osteoarthritis
- What is being tested?
- GXCPC1 and HA
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTaiwan
- Study dates
- 1 Dec 2019to 22 Mar 2023
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
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- 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)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis
The aim of the investigators study was to investigate the safety and efficacy of allogeneic ADSCs for the clinical treatment of knee osteoarthritis.
- Conditions
- Knee Osteoarthritis
- Being tested
- GXCPC1, HA
- Medical subject headings
- Osteoarthritis, Knee
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GXCPC1Drug
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)
HADevice
Hya Joint Plus synovial fluid supplement 3mL
| Study group | Role | What they receive |
|---|---|---|
| GXCPC1 | Experimental | GXCPC1 contains 6.7×10^6 or 4×10^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL Receives: Drug: GXCPC1 |
| hyaluronic acid | Active comparator | Hya Joint Plus synovial fluid supplement 3mL Receives: Device: HA |
What is being measured
The primary outcome is the main question the study is designed to answer.
WOMAC pain score
Change from baseline in WOMAC pain score at Week 24
Measured: week 24
Secondary outcomes (3)
MRI
Change from baseline to post-treatment visits on the target knee in MRI examination results
Measured: week 0, 24, 48
Visual Analogue Scale (VAS)
Changes from baseline to post-treatment visits on the target knee in Visual Analogue Scale (VAS) for pain
Measured: week 0, 1, 4, 12, 24
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
Measured: week 0, 1, 4, 12, 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start1 Dec 2019
- Primary completion27 Apr 2022
- Study completion22 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee OsteoarthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Cheng-FONG Chen, Principal investigator, Taipei Veterans General Hospital, Taiwan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943576
- Sponsor's protocol ID
- GXCPC1
- Status last verified
- Jun 2023
- First submitted
- 23 Jan 2019
- Last updated
- 6 Jun 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Chen CF, Chen YC, Fu YS, Tsai SW, Wu PK, Chen CM, Chen WM, Wu HH, Lee CH, Chang CL, Lin PC, Kao YC, Chen CH, Chuang MH. Safety and Tolerability of Intra-Articular Injection of Adipose-Derived Mesenchymal Stem Cells GXCPC1 in 11 Subjects With Knee Osteoarthritis: A Nonrandomized Pilot Study Without a Control Arm. Cell Transplant. 2024 Jan-Dec;33:9636897231221882. doi: 10.1177/09636897231221882.
PubMed 38205679
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adipose-Derived Stem Cells (ADSCs) Injections for Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT03943576
- Acronym / sponsor ID
- GXCPC1
- Conditions
- Knee Osteoarthritis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Gwo Xi Stem Cell Applied Technology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 1 Dec 2019 (actual)
- Primary completion
- 27 Apr 2022 (actual)
- Study completion
- 22 Mar 2023 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the investigators study was to investigate the safety and efficacy of allogeneic ADSCs for the clinical treatment of knee osteoarthritis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GXCPC1 | Experimental | Drug: GXCPC1GXCPC1 contains 6.7×10^6 or 4×10^7 allogeneic adipose-derived stem cells (ADSCs) in 3 mL |
| hyaluronic acid | Active comparator | Device: HAHya Joint Plus synovial fluid supplement 3mL |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GXCPC1The 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) | Drug | GXCPC1 |
| HAHya Joint Plus synovial fluid supplement 3mL | Device | hyaluronic acid |
Primary outcome
WOMAC pain score
Time frame: week 24
Change from baseline in WOMAC pain score at Week 24
3 secondary outcomes
MRI
Time frame: week 0, 24, 48
Visual Analogue Scale (VAS)
Time frame: week 0, 1, 4, 12, 24
12-item Short Form (SF-12)
Time frame: week 0, 1, 4, 12, 24
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jun 2023.
- Derived from this study: PubMed 38205679Chen CF, Chen YC, Fu YS, Tsai SW, Wu PK, Chen CM, Chen WM, Wu HH, Lee CH, Chang CL, Lin PC, Kao YC, Chen CH, Chuang MH. Safety and Tolerability of Intra-Articular Injection of Adipose-Derived Mesenchymal Stem Cells GXCPC1 in 11 Subjects With Knee Osteoarthritis: A Nonrandomized Pilot Study Without a Control Arm. Cell Transplant. 2024 Jan-Dec;33:9636897231221882. doi: 10.1177/09636897231221882.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cheng-FONG Chen principal investigator
Taipei Veterans General Hospital, Taiwan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing GXCPC1 and HA in people with Knee Osteoarthritis, run by Gwo Xi Stem Cell Applied Technology Co., Ltd. at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
WOMAC pain score (time frame: week 24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943576, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jun 2023.