Osteoarthritis, KneePhase 1/2MSC-OANCT04240873
Clinical Study of Intra Articular Injection of Catholic MASTER Cell (Bone Marrow Derived Mesenchymal Stem Cell) in Knee Osteoarthritis
A Phase 1/2 study testing Catholic MASTER cell and Saline in people with Osteoarthritis, Knee, run by Seoul St. Mary's Hospital at 1 site in South Korea.
Trial summary
1. objective safety and efficacy evalaution of MASTER cells injected into knee of patients with osteoarthritis 2. background osteoarthritis Osteoarthritis is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury. Read more about this study
- Who is it for?
- Ages 20 to 80 years
- Conditions the study is for
- Osteoarthritis, Knee
- What is being tested?
- Catholic MASTER cell and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSouth Korea
- Study dates
- 15 Nov 2019to 31 Mar 2022
- 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 20 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 20-80
- diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA
- symptomatic OA that lastede for at least 3 months before screening
- Baseline Pain VAS ≥50 mm
- treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain
- X-ray Kellgren-Lawrence grade 1~4
- volauntarily enrolled with informed consent
- no improvement with medical treatment for at least 3 months
Who cannot join
- disease in spine or lower extremities that can affect the outcome of index knee
- surgery on lower extremities within 6month before injection or planned
- joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis
- steroid injection to the index knee within preivious 3months
- hyaluronic acid injection to the index knee within preivious 6months
- underwent cell therapy or gene therapy in the past
Show all 13Show fewer
- more than 3 times upper normal limit in one or more of the followings: serum creatinine, bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST) or more than 3 times upper normal limit in two or more of the followings: bilirubin, alanine aminotransferase (ALT) or aspartate aminotransferase (AST)
- participation in a different clinical trial other than this within 4 weeks after initiation of the current study
- use (reccuent use or addiction) of substances that can affect pain sensation such as narcotics
- females of childbearing age who do not consent to effective contraceptive methods during the study period
- pregnant or lactating woman
- malignancy
- considered to be inappropriate for the trial by investigators
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Catholic University of Korea
Seoul, 06950
Ji Hyeon Ju, MD, PhD
About this study
Official title: Randomized Double-blind Clinical Study of Intra Articular Injection of Catholic MASTER Cell in Knee Osteoarthritis
- objective
- safety and efficacy evalaution of MASTER cells injected into knee of patients with osteoarthritis
Read more
- background
- osteoarthritis
- Osteoarthritis is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury.
- OA is one of the most prevalent diseases. The prevalence increases with age, but overuse and trauma can result in OA in young population as well.
- Injured cartilage can not be regenerated spontaneously, untreated injured cartilage eventually leads to osteoarthritis. Surgical treatment may repair the damage but the reparied cartilage may turn out to be fibrocartilage rather than hyaline cartilage.
- Curent treatment
- medical therapy: medication for symptom relief, together with exercise. Medications include NSAIDS visco-supplement.
- surgical therapy: total knee replacement arthroplasty
- to overcome such limitations, cell therapy such as stem cell/ chondrocyte injection is being investigated
- Hypothesis
- Intra articular injection of MASTER cells will show safety and efficacy in terms of pain and functional improvement.
- Protocol 1) deisgn : Injection of MASTER cell 1X 10^8 cells/2cc (experimental arm) or 2cc saline (placebo arm) into knee of patients with osteoarthritis 2) outcomes
- primary outcome : safety evaluation(adverse event)
- secondary outcomes : check on 1,2,3,6,9,12 months, atient reported outcome (WOMAC, KOOS, IKDC, pain VAS) 3,12 months SF-36, knee MRI score, serum cytokine, bone turnover marker 12 months x-ray 3) Disease
- osteoarthritis
- Subjects
- inclusion : age 20-80yrs, diagnosed with OA according to ACR criteria for knee OA, baseline pain VAS equal or more than 50mm
- exclusion: lower extremities surgery within 6months or planned surgery, concommitant systemic rheumatic diseases that can affect the results of the trial, steroid intraarticular inejction into the index knee within 3months, clinicallly meaningful abnormal lab tests (liver function, kidney function)
- evaluation
- primary outome : compare the number and proportion of of adverse event and lab test abnormalities between the two arms
- secondary outome
- change of 100mm pain VAS
- change of Western Ontario and McMAster Universities Osteoarthritis (WOMAC) pain VAS, IKDC, KOOS total score
- change WOMAC sub scale, IKDC, KOOS
- chagne of KHAQ
- change of MRI indices
- change of x-ray( joins space narrowing)
- change of serum ESR/CRP, CTX-II
- Conditions
- Osteoarthritis, Knee
- Being tested
- Catholic MASTER cell, Saline
- Keywords
- osteoarthritis, mesenchymal stem cell
- Medical subject headings
- Osteoarthritis, Knee, Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Catholic MASTER cellBiological
Injection of CATHOLIC MASTER cells 1 x 10^8 cells/DMEM 5cc into knee of patents with osteoarthritis
SalineOther
Injection of saline 5cc into knee of patents with osteoarthritis
| Study group | Role | What they receive |
|---|---|---|
| MASTER cell | Experimental | Intraarticular injection of Catholic MASTER cell, 1 time, 1 x 10^8 cells/DMEM 5cc, into knee joint of patients with osteoarthritis Receives: Biological: Catholic MASTER cell |
| Saline | Placebo comparator | Intraarticular injection of saline, 1 time, 5cc, into knee joint of patients with osteoarthritis Receives: Other: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood)
Measured: Change from Baseline blood abnormalities at 12 month
Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Measured: Change from Baseline WOMAC score at 12 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Measured: Change from Baseline KOOS score at 12 month
International knee documentation committee (IKDC)
Measured: Change from Baseline IKDC score at 12 month
Cartilage damage evaluation through knee MRI
Measured: Change from Baseline cartilage morphology at 12 month
SF-36 questionnaire
Measured: Change from Baseline SF-36 score at 12 month
Serum inflammatory cytokine, acute phase reactant, bone turnover marker
Measured: Change from Baseline cytokine level, acute phase reactant, bone turnover marker level at 12 month
Cartilage damage evaluation through knee x-ray
Measured: Change from Baseline cartilage and bone morphology at 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2020
- Study start15 Nov 2019
- Primary completion31 Mar 2021 (estimated)
- Study completion31 Mar 2022 (estimated)
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 Osteoarthritis, KneeStudies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul St. Mary's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ji Hyeon Ju, Seoul St. Mary's Hospital
- Investigators
- Ji Hyeon Ju, MD, PhD, Principal investigator, The Catholic University of Korea
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04240873
- Sponsor's protocol ID
- KC19CNSI0469
- Acronym
- MSC-OA
- Status last verified
- Jan 2020
- First submitted
- 10 Dec 2019
- Last updated
- 27 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Lee BW, Lee JJ, Jung JY, Ju JH. Intra-Articular Injection of Human Bone Marrow-Derived Mesenchymal Stem Cells in Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Trial. Cell Transplant. 2025 Jan-Dec;34:9636897241303275. doi: 10.1177/09636897241303275.
PubMed 39874108
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-blind Clinical Study of Intra Articular Injection of Catholic MASTER Cell in Knee Osteoarthritis
- ClinicalTrials.gov ID
- NCT04240873
- Acronym / sponsor ID
- MSC-OA / KC19CNSI0469
- Conditions
- Osteoarthritis, Knee
- Keywords
- osteoarthritis, mesenchymal stem cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Seoul St. Mary's HospitalUniversity, hospital or other
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 31 Mar 2021 (estimated)
- Study completion
- 31 Mar 2022 (estimated)
- First posted
- 27 Jan 2020 (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.
- objective
- safety and efficacy evalaution of MASTER cells injected into knee of patients with osteoarthritis
- background
- osteoarthritis
- Osteoarthritis is severe and intractable musculoskeletal disease that eventually leads to joint failure and pain due to inflammation and joint injury.
- OA is one of the most prevalent diseases. The prevalence increases with age, but overuse and trauma can result in OA in young population as well.
- Injured cartilage can not be regenerated spontaneously, untreated injured cartilage eventually leads to osteoarthritis. Surgical treatment may repair the damage but the reparied cartilage may turn out to be fibrocartilage rather than hyaline cartilage.
- Curent treatment
- medical therapy: medication for symptom relief, together with exercise. Medications include NSAIDS visco-supplement.
- surgical therapy: total knee replacement arthroplasty
- to overcome such limitations, cell therapy such as stem cell/ chondrocyte injection is being investigated
- Hypothesis
- Intra articular injection of MASTER cells will show safety and efficacy in terms of pain and functional improvement.
- Protocol 1) deisgn : Injection of MASTER cell 1X 10^8 cells/2cc (experimental arm) or 2cc saline (placebo arm) into knee of patients with osteoarthritis 2) outcomes
- primary outcome : safety evaluation(adverse event)
- secondary outcomes : check on 1,2,3,6,9,12 months, atient reported outcome (WOMAC, KOOS, IKDC, pain VAS) 3,12 months SF-36, knee MRI score, serum cytokine, bone turnover marker 12 months x-ray 3) Disease
- osteoarthritis
- Subjects
- inclusion : age 20-80yrs, diagnosed with OA according to ACR criteria for knee OA, baseline pain VAS equal or more than 50mm
- exclusion: lower extremities surgery within 6months or planned surgery, concommitant systemic rheumatic diseases that can affect the results of the trial, steroid intraarticular inejction into the index knee within 3months, clinicallly meaningful abnormal lab tests (liver function, kidney function)
- evaluation
- primary outome : compare the number and proportion of of adverse event and lab test abnormalities between the two arms
- secondary outome
- change of 100mm pain VAS
- change of Western Ontario and McMAster Universities Osteoarthritis (WOMAC) pain VAS, IKDC, KOOS total score
- change WOMAC sub scale, IKDC, KOOS
- chagne of KHAQ
- change of MRI indices
- change of x-ray( joins space narrowing)
- change of serum ESR/CRP, CTX-II
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MASTER cell | Experimental | Biological: Catholic MASTER cellIntraarticular injection of Catholic MASTER cell, 1 time, 1 x 10^8 cells/DMEM 5cc, into knee joint of patients with osteoarthritis |
| Saline | Placebo comparator | Other: SalineIntraarticular injection of saline, 1 time, 5cc, into knee joint of patients with osteoarthritis |
Who may qualify
- Ages
- 20 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age 20-80
- diagnosed with knee osteoarthritis (OA) according to ACR classfication criteia for knee OA
- symptomatic OA that lastede for at least 3 months before screening
- Baseline Pain VAS ≥50 mm
- treated with medication such as acetaminophen, tramadol, NSAID for at least 1month due to OA pain
Key exclusion criteria (13 listed)
- disease in spine or lower extremities that can affect the outcome of index knee
- surgery on lower extremities within 6month before injection or planned
- joint symptoms that can affect the interpretation of the trial data or prevent the subject from enrollement including but not limited to symptomatic fracture, fibromyalgia, rheumatoid arthritis, reactive arthritis
- steroid injection to the index knee within preivious 3months
- hyaluronic acid injection to the index knee within preivious 6months
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 |
|---|---|---|
| Catholic MASTER cellInjection of CATHOLIC MASTER cells 1 x 10^8 cells/DMEM 5cc into knee of patents with osteoarthritis | Biological | MASTER cell |
| SalineInjection of saline 5cc into knee of patents with osteoarthritis | Other | Saline |
Primary outcome
adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood)
Time frame: Change from Baseline blood abnormalities at 12 month
Western Ontario and McMaster Universities Arthritis Index (WOMAC) score
Time frame: Change from Baseline WOMAC score at 12 month
Knee injury and Osteoarthritis Outcome Score (KOOS)
Time frame: Change from Baseline KOOS score at 12 month
International knee documentation committee (IKDC)
Time frame: Change from Baseline IKDC score at 12 month
Cartilage damage evaluation through knee MRI
Time frame: Change from Baseline cartilage morphology at 12 month
SF-36 questionnaire
Time frame: Change from Baseline SF-36 score at 12 month
Serum inflammatory cytokine, acute phase reactant, bone turnover marker
Time frame: Change from Baseline cytokine level, acute phase reactant, bone turnover marker level at 12 month
Cartilage damage evaluation through knee x-ray
Time frame: Change from Baseline cartilage and bone morphology at 12 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2020.
- Derived from this study: PubMed 39874108Lee BW, Lee JJ, Jung JY, Ju JH. Intra-Articular Injection of Human Bone Marrow-Derived Mesenchymal Stem Cells in Knee Osteoarthritis: A Randomized, Double-Blind, Controlled Trial. Cell Transplant. 2025 Jan-Dec;34:9636897241303275. doi: 10.1177/09636897241303275.
- Individual participant dataSharing planned: Undecided
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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.
Ji Hyeon Ju, MD, PhD principal investigator
The Catholic University of Korea
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 Catholic MASTER cell and Saline in people with Osteoarthritis, Knee, run by Seoul St. Mary's Hospital at 1 site in South Korea.
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 8 inclusion and 13 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: status not confirmed, as of the sponsor's last update on 27 Jan 2020. 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 South Korea. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ji Hyeon Ju, MD, PhD (82-2-2258-6893, juji@catholic.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
adverse event according to CTCAE 5.0, clinically meaningful abnormalites in laboratory tests (blood) (time frame: Change from Baseline blood abnormalities at 12 month). The study lists 8 primary outcomes in all. 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 NCT04240873, 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 27 Jan 2020.