Rheumatoid ArthritisPhase 1RANCT02221258
Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis(RA)
A Phase 1 study testing FURESTEM-RA Inj. in people with Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. at 1 site in South Korea.
Trial summary
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion. 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.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 1 siteSouth Korea
- Study dates
- Oct 2014to Oct 2015
- Phase
- Phase 1
- 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 with ACR functional class I. II, III Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- Subjects must be taking DMARDs or NSAIDs including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide of stable dose within 12 weeks before screening 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
- Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
- Subject who understands and voluntarily sign an informed consent form
Who cannot join
- Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- Subjects who has cardiovascular disorders, blood dyscrasia, AIDS(Acquired Immune Deficiency Syndrome), other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- subject who has administered the following biological DMARDs
- subject who has administered more than 1 drugs(Infliximab, Adalimumab, Etanercept, Anakinra, Abatacept) within 6 months before screening visit
- subject who has administered Rituximab within 1 year before screening visit
- Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
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- Subject who has treated 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.
- Subject who has diseases or takes medicine which are prohibited prescription of NSAIDs.
- Subject who needs to take the medicine which is prohibited to take at the same time
- Pregnant, breast-feeding women
- 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
- Subject who experienced stem cell therapy
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul national University Boramae medical center
Seoul, Seoul, 156-707
About this study
Official title: Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
The purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Read the detailed description
Rheumatoid arthritis(RA) is a chronic and progressive autoimmune disease characterized by synovial hyperplasia and joint damage leading to clinically significant functional impairment. In RA, for some unknown reason, immune cells infiltrate into synovium of joint and produce the 'rheumatoid factor', prostaglandins, cytokines and other mediators. It damages joint and cartilage, even other organs. 80% of the RA patients have Rheumatoid factor which is caused by high expression ratio of auto-antibodies in blood. Produced immune complexes, immune cells and antigen-presenting cells(including macrophages, B cells, dendritic cells) activate and release cytokines and then synovial tissue becomes thickened and damaged.
It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α blockers, abatacept and rituximab, often in combination with MTX, are effective. But they still are limited by lack or loss of efficacy in certain patients and serious complications such as serious infections and malignancies. So, there is a need to identify new treatment.
FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types including osteocytes and chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products for RA patients.
- Conditions
- Rheumatoid Arthritis
- Being tested
- FURESTEM-RA Inj.
- Keywords
- Rheumatoid Arthritis, Rheumatic Disease, RA, Stem cell, Cell therapy, furestem, Umbilical cord Blood, hUCB-MSC, UCB-MSC
- Medical subject headings
- Arthritis, Rheumatoid, Rheumatic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FURESTEM-RA Inj.Biological
Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs)
| Study group | Role | What they receive |
|---|---|---|
| FURESTEM-RA Inj.+DMARDs | Experimental | FURESTEM-RA Inj. 1. 2.5x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 2. 5.0x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 3. 1.0x10^8 stem cells+DMARDs after registration Receives: Biological: FURESTEM-RA Inj. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of FURESTEM-RA Inj. treatment
Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs
Measured: 4 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 posted20 Aug 2014 (estimated)
- Study startOct 2014
- Primary completionOct 2015
- Study completionOct 2015
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kang Stem Biotech Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kichul Shin, Principal investigator, SMG-SNU Boramae Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221258
- Sponsor's protocol ID
- KSB-RA
- Acronym
- RA
- Status last verified
- Mar 2015
- First submitted
- 18 Aug 2014
- Last updated
- 6 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Clinical Trial to Evaluate the Safety of FURESTEM-RA Inj. in Patients With Moderate to Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT02221258
- Acronym / sponsor ID
- RA / KSB-RA
- Conditions
- Rheumatoid Arthritis
- Keywords
- Rheumatoid Arthritis, Rheumatic Disease, RA, Stem cell, Cell therapy, furestem, Umbilical cord Blood, hUCB-MSC
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Kang Stem Biotech Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2014
- Primary completion
- Oct 2015 (actual)
- Study completion
- Oct 2015 (actual)
- First posted
- 20 Aug 2014 (estimated)
- 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 purpose of phase 1 clinical trial is to to evaluate safety in subjects with moderate to severe rheumatoid arthritis after infusion.
Detailed description
Rheumatoid arthritis(RA) is a chronic and progressive autoimmune disease characterized by synovial hyperplasia and joint damage leading to clinically significant functional impairment. In RA, for some unknown reason, immune cells infiltrate into synovium of joint and produce the 'rheumatoid factor', prostaglandins, cytokines and other mediators. It damages joint and cartilage, even other organs. 80% of the RA patients have Rheumatoid factor which is caused by high expression ratio of auto-antibodies in blood. Produced immune complexes, immune cells and antigen-presenting cells(including macrophages, B cells, dendritic cells) activate and release cytokines and then synovial tissue becomes thickened and damaged.
It has been reported that synthetic DMARDs(disease-modifying antirheumatic drugs) including methotrexate(MTX), sulfasalazine and biological DMARDs such as tumor necrosis factors(TNF)-α blockers, abatacept and rituximab, often in combination with MTX, are effective. But they still are limited by lack or loss of efficacy in certain patients and serious complications such as serious infections and malignancies. So, there is a need to identify new treatment.
FURESTEM-RA Inj. is composed of allogeneic hUCB-MSC(human Umbilical Cord Blood derived-Mesenchymal Stem cell). hUCB-MSCs are mesenchymal stem cells from umbilical cord blood. Mesenchymal stem cells are well-known for immunosuppression, anti-inflammatory ability and capable of differentiating into a wide range of cell types including osteocytes and chondrocytes. Therefore, FURESTEM-RA Inj. has huge possibility as cell therapy products for RA patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| FURESTEM-RA Inj.+DMARDs | Experimental | Biological: FURESTEM-RA Inj.FURESTEM-RA Inj. 1. 2.5x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 2. 5.0x10^7 stem cells+DMARDs after registration FURESTEM-RA Inj. 3. 1.0x10^8 stem cells+DMARDs after registration |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- of either gender, 19-80years old
- Subjects must be diagnosed with ACR functional class I. II, III Rheumatoid Arthritis according to the 2010 ACR/EULAR criteria for at least 12 weeks duration.
- Subjects must be taking DMARDs or NSAIDs including methotrexate, sulfasalazine, hydroxychloroquine, leflunomide of stable dose within 12 weeks before screening 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
- Subject who has moderate to severe disease activity (DAS28-ESR>3.2) on screening visit
Key exclusion criteria (16 listed)
- Subjects who is diagnosed ACR function class IV Rheumatoid Arthritis
- Subjects who has cardiovascular disorders, blood dyscrasia, AIDS(Acquired Immune Deficiency Syndrome), other rheumatic disease(Crohn's disease, systemic lupus erythematosus, lyme disease, psoriatic arthritis, spondylarthropathy, infectious or reactive arthritis, reiter's syndrome, etc.)
- subject who has administered the following biological DMARDs
- Subject who has history of hypersensitivity, heavy metal poisoning, etc. to drugs which is composed of similar components.
- Subject who has treated intra-articular steroid injection within 4 weeks before screening visit
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 Inj.Patients will be treated FURESTEM-RA Inj.+DMARDs(Disease-Modifying antirheumatic drugs) | Biological | FURESTEM-RA Inj.+DMARDs |
Primary outcome
Safety of FURESTEM-RA Inj. treatment
Time frame: 4 weeks follow-up after treatment
Evaluate the number of adverse events, including clinically significant changes in physical examination, safety lab tests, ECG, vital signs
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 Oct 2016.
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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.
Kichul Shin principal investigator
SMG-SNU Boramae Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing FURESTEM-RA Inj. in people with Rheumatoid Arthritis, run by Kang Stem Biotech Co., Ltd. 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 6 inclusion and 16 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 Oct 2016. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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. treatment (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 6 Oct 2016.