Rheumatoid ArthritisPhase 1/2NCT03618784
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
A Phase 1/2 study testing FURESTEM-RA Inj and sterile saline in people with Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 7 sites in South Korea.
Trial summary
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- FURESTEM-RA Inj and sterile saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 7 sitesSouth Korea
- Study dates
- 11 Jul 2018to 13 May 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 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- of either gender, 19-80years old
- Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- Subjects must be diagnosed with ACR functional class I. II, III
- ≥ 6 tender joints, swollen joints (68 joint count) at Screening
- Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
- History of treatment for one of conventional DMARDs or biologic DMARDs or JAK inhibitors AND people diagnosed with either (a) or (b) by a trained person, or people that have potential side effects thus not qualified from using biologic DMARDs.
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- people that have no effect with permitted dose taking for more than 3 months
- people with a history of side effects of relevant treatment
- Subjects must be taking cDMARDs(including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide) or tacrolimus of stable dose More than 12 weeks before baseline visit and be willing to remain on stable dose throughout the study
- If subject is currently administering steroids everyday, when steroid dose is converted into prednisolone oral dose, the subject should take a stable dose(≤10mg/day) over 4 weeks on screening visit
- In case of taking NASAIDs, Tramadol patients with stable amount of medication at least 2 weeks before screening visit.
- During screening visit , patients with an ESR result of 28mm/hr; patients with a 1.0mg/dL or greater in a CRP testing
- Subject who understands and voluntarily sign an informed consent form
Who cannot join
- Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical trials due to uncontrolled or unstable cardiovascular disease or severe blood disease
- Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- Prior use of bDMARDs, within the following windows prior to baseline
- 24 weeks for Rituximab
- 10 weeks for Abatacept, Golimumab, Certolizumab pegol, Tocilizumab
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- 7 weeks for Infliximab
- 4 weeks for Etanercept
- 3 weeks for Tofacitinib, Baricitinib
- Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
- Subject who has treated intravenous, intramuscular steroid injection within 2 weeks before screening visit or intra-articular steroid injection within 4 weeks before screening visit
- Subject who has administered ACTH(adrenocorticotropic hormone) agents within 4 weeks before screening visit
- Subject who has undergone administration of any investigational drug within 30 days before screening visit.
- Use of prohibited medication or inability to avoid the use of prohibited medication during the study
- Pregnant, breast-feeding women
- A female or male in their childbearing ages that is not willing to take proper contraceptive methods during a study
- Subject who has sever dyshepatia (Serum creatinine level ≥ 1.7mg/dl)
- Subject who has severe renal dysfunction (ALT/AST/bilirubin value ≥ 2 upper limit of the normal range at screening test)
- Any other condition which the PI Judges would make patient unsuitable for study participation
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
South Korea7 sites
Chonnam National University Hospital
Gwangju
Gangdong Kyung Hee University Hospital
Seoul
Konkuk University Medical Center
Seoul
Kyung Hee University Hospital
Seoul
Seoul Hospital attached to Soonchunhyang University
Seoul
Seoul national University Boramae
Seoul
Seoul National University Hospital
Seoul
About this study
Official title: A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis
Read the detailed description
Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis
- Conditions
- Rheumatoid Arthritis
- Being tested
- FURESTEM-RA Inj, sterile saline
- Keywords
- FURESTEM-RA Inj., Rheumatoid Arthritis, Cell therapy
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-RA InjBiological
The allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.
- Dose level 1: 5.0 x 10^7 cells /body 3 repeated intravenous injection at 4 week intervals
- Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals
sterile salineOther
sterile saline 3 repeated intravenous injection at 4 week intervals
Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension.
Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump.
| Study group | Role | What they receive |
|---|---|---|
| FURESTEM-RA Inj. | Experimental | Not described Receives: Biological: FURESTEM-RA Inj |
| Placebo Comparator: Placebo | Placebo comparator | Not described Receives: Other: sterile saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of FURESTEM-RA Inj. - number of adverse events
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
Measured: 4 weeks follow-up after treatment
Secondary outcomes (8)
Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
Measured: 16 weeks follow-up after treatment
Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
Measured: 16 weeks follow-up after treatment
Efficacy as measured by DAS(Disease activity scores)28-ESR
DAS range is from ≥ 3.2 (inactive) , >3.2 but ≤ 5.1(moderate), >5.1(very active)
Measured: 16 weeks follow-up after treatment
Efficacy as measured by KHAQ(Korean Health assessment questionnaire)
KHAQ range is from 0 (clear) to 60 (severe)
Measured: 16 weeks follow-up after treatment
Efficacy as measured by CDAI (clinical disease activity index)
CDAI range is from 0 (clear) to 76 (severe)
Measured: 16 weeks follow-up after treatment
Efficacy as measured by 100mm Pain VAS(Visual analogue scale)
100mm Pain VAS range is from 0 (clear) to 100 (severe)
Measured: 16 weeks follow-up after treatment
Total number of use and consumed amount of rescue medicine
Measured: 16 weeks follow-up after treatment
Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22)
Measured: 16 weeks follow-up after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2018
- Study start11 Jul 2018
- Primary completion5 Oct 2021
- Study completion13 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03618784
- Sponsor's protocol ID
- K0202
- Status last verified
- Oct 2022
- First submitted
- 24 Jul 2018
- Last updated
- 10 Oct 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-center, Randomized, Double-blind, Parallel, Placebo-controlled Phase I/2a Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT03618784
- Acronym / sponsor ID
- K0202
- Conditions
- Rheumatoid Arthritis
- Keywords
- FURESTEM-RA Inj., Rheumatoid Arthritis, Cell therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 11 Jul 2018 (actual)
- Primary completion
- 5 Oct 2021 (actual)
- Study completion
- 13 May 2022 (actual)
- First posted
- 7 Aug 2018 (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.
Safety and Efficacy of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid arthritis
Detailed description
Phase 1: Single center, open Phase 2a : Multi-center, randomized, double-blind, parallel, placebo Clinical Trial to Evaluate the Efficacy and Safety of FURESTEM-RA Inj. for Moderate to Severe Rheumatoid arthritis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| FURESTEM-RA Inj. | Experimental | Biological: FURESTEM-RA Inj |
| Placebo Comparator: Placebo | Placebo comparator | Other: sterile saline |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- of either gender, 19-80years old
- Subjects must be diagnosed according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- Subjects must be diagnosed with ACR functional class I. II, III
- ≥ 6 tender joints, swollen joints (68 joint count) at Screening
- Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
Key exclusion criteria (19 listed)
- Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- Patients who are judged by the PI(or Sub-I) to be unable to participate in clinical trials due to uncontrolled or unstable cardiovascular disease or severe blood disease
- Subjects who has AIDS, other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- Prior use of bDMARDs, within the following windows prior to baseline
- Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
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 |
|---|---|---|
| FURESTEM-RA InjThe allogeneic umbilical cord blood-derived mesenchymal stem cells of each dose level as below were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump. * Dose level 1: 5.0 x 10^7 cells /body 3 repeated intravenous injection at 4 week intervals * Dose level 2: 1.0 x 10^8 cells /body 3 repeated intravenous injection at 4 week intervals | Biological | FURESTEM-RA Inj. |
| sterile salinesterile saline 3 repeated intravenous injection at 4 week intervals Placebo were mixed into an IV bag containing 100 ml of sterile saline solution and the IV bag was gently massaged to obtain homogeneous mixture of the cell suspension. Administer the constituted cell suspension by IV infusion to a subject. The infusion should be completed in 60 minutes using infusion pump. | Other | Placebo Comparator: Placebo |
Primary outcome
Safety of FURESTEM-RA Inj. - number of adverse events
Time frame: 4 weeks follow-up after treatment
Evaluate the number of adverse events Safety of FURESTEM-RA Inj.
8 secondary outcomes
Efficacy as measured by ACR(American College of Rheumatology)20,50,70 reaction rate
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by EULAR (European League Against Rheumatism)reaction rate
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by DAS(Disease activity scores)28-ESR
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by KHAQ(Korean Health assessment questionnaire)
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by CDAI (clinical disease activity index)
Time frame: 16 weeks follow-up after treatment
Efficacy as measured by 100mm Pain VAS(Visual analogue scale)
Time frame: 16 weeks follow-up after treatment
Total number of use and consumed amount of rescue medicine
Time frame: 16 weeks follow-up after treatment
Change in Cytokine(TNF-a, Interleukin (IL)-1b, IL-4,IL-6,IL-8,IL-10,IL-13,IL-17A,IL-21,IL-22)
Time frame: 16 weeks follow-up after treatment
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 10 Oct 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
7 sites 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 FURESTEM-RA Inj and sterile saline in people with Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 7 sites 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 13 inclusion and 19 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 10 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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?
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?
Safety of FURESTEM-RA Inj. - number of adverse events (time frame: 4 weeks follow-up after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Oct 2022.