Lupus NephritisPhase 1NCT03174587
Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis
A Phase 1 study testing allogenic bone marrow derived mesenchymal stem cells in people with Lupus Nephritis, run by Corestemchemon, Inc. at 1 site in South Korea.
Trial summary
The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis. Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients. Read more about this study
- Who is it for?
- Ages 18 to 69 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- allogenic bone marrow derived mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSouth Korea
- Study dates
- 30 May 2017to 19 Aug 2019
- 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 18 to 69 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female Patients aged ≥18 years and < 70years.
- Patients with HLA-haplo-matched bone marrow donor is less than 70 years old.
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Patients had suffered from active renal disease in the past or patients has active renal disease now. Active renal disese should have include below.
- Spot urine protein/creatinine ratio ≥ 1.0 and ① >5 RBC/HPF, ② >5 WBC/HPF, ③ columnar cell.
- Biopsy confirmed active type III or type IV, or type V lupus nephritis.
- Patients can be immunosuppressive agent to , steroids, taking, such as anti-Malarials (hydroxychloroquine) in a certain capacity, during the test period, to maintain the same capacity before 4-weeks screening.
- Patients who consented to participate in the study in writing by themselves or their legal representatives.
Who cannot join
- Those who do not kidney disease for SLE.
- Patients with a history of hypersensitivity, such as heavy metal poisoning similar to drug testing and drug ingredients.
- Patients a history Major organs (kidney, liver, lung, heart) transplant or liver hematopoietic cells / transplant or during of scheduled transplantation clinical trial.
- patients a history of kidney dialysis or during of the scheduled dialysis clinical trials within 2 weeks prior to the screening.
- Tested positive for hepatitis B(HBsAg, Anti-HBcAB, HBV-DNA) and hepatitis C(Anti-HCV, HCV-RNA) \.
- Patients a history of anaphylactic reaction for the parenteral administration of a monoclonal antibody or contrast agent, a mouse protein or human.
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- Patients whose e-GFR ≤ 30mL/min at screening.
- Patients with a history of malignancy within 5 years prior to the screening(basal cell carcinoma of skin, squamous cell carcinoma of skin, or cervical intraepithelial neoplasia are excluded).
- Patients who were administered drug of the follow within 6 months prior to the screening.
- nitrogen mustard, chlorambucil, vin·cris·tine, procarbazine, Abatacept, Rituximab, Belimumab
- Patients who were administered drug of the follow within 3 months prior to the screening.
- Anti-TNF therapy(Etanercept, adalimumab, Infliximab, golimumab, Tocilizumab)
- Interleukin-1 receptor antagonist(anakinra)
- Intravenous immunoglobulin(IVIG)
- Plasmapheresis
- Those who are hypersensitive to antibiotics including penicillin and streptomycin.
- Patients with systemic infection at screening.
- Uncontrolled hypertension or diabetes.
- If that may affect proteinuria increased capacity or begin taking medication(ACE inhibitors, ARB (Angiotensin Receptor Blocker)) (However, more than four weeks allowed capacity, taking is possible during the trial period without changing capacity).
- Patients who showed myocardial infarction or angina on ECG at screening, or received stent procedure or bypass.
- Patients who were administered another study drug 3 months prior to the study.
- Patients with severe mental disease(for example, schizophrenia, bipolar disorder etc;).
- Patients are expected to be administered the combination contraindicated drugs about inevitable or taker within clinical trial.
- Women of childbearing age are not implement adequate contraception during clinical trials. the proper method of contraception, which has Oral contraceptive continued more than four weeks, a surgical procedures including the insertion loop, condom use etc. and Medically it is determined that there is no possibility of pregnant women do not belong to women of childbearing age due to the ovary removal, hysterectomy and menopause, etc.
- Pregnant women or nursing women.
- Except as permitted in the following Case and laboratory test results than moderate adverse events(NCI-CTC (National Cancer Institute-Common Toxicity Criteria) version 4.0) grade 3.
- proteinuria
- hematuria
- pyuria
- Columnar
- Hypoalbuminemia caused by lupus nephritis
- Class III due to stable prothrombin time of warfarin therapy
- Lupus anticoagulant group, and are not associated with liver disease or stable anticoagulation 3 grade partial thromboplastin time
- Lupus due to hepatitis and alcoholic liver disease, are not associated with uncontrolled diabetes or viral hepatitis stable 3 grade gamma glutamyl transferase (GGT) increases. If it appears to be less than ALT and / or AST is above all on the second level.
- Stable grade 3 neutropenia or white blood cell count
- Patients who previously received stem cell therapy.
- Subjects who by the investigator to make them ineligible for participation in this clinical study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.
The purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.
Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.
Read the detailed description
Lupus is a representative autoimmune disease that affects the whole body. It is occurred by generation of autoantibody and immune complex due to abnormal activation of the immune cells on the basis of abnormal immune responses.
Although about 50% of lupus patients have lupus nephritis, there is no therapy product targeted for the lupus nephritis now.
We have performed the pre-clinical and clinical studies using allogenic bone marrow derived mesenchymal stem cells in SLE.
CS20AT04 has anti-inflammatory effects, controls activity of immune cells and reduces generation of autoantibodies. So, it is expected to have treatment effects of lupus nephritis.
The clinical trial was designed as a single center, open-label, phase 1 clinical trials.
If that subject's written informed consent form to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol within 56 days investigational drug administration.
Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.
Check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 3 days, 7 days and 28 days.
Except for dose administration, all subject are tested in the same schedule. As a result of evaluating severity of AE divided into grades in accordance with the CTCAE (Version 4.0) standards.
- Conditions
- Lupus Nephritis
- Being tested
- allogenic bone marrow derived mesenchymal stem cells
- Keywords
- Systemic lupus erythematosus, HLA-haplo-matching, allogenic bone marrow derived mesenchymal stem cell, Phase 1 clinical trial
- Medical subject headings
- Lupus Nephritis, Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogenic bone marrow derived mesenchymal stem cellsBiological
Also called CS20AT04
Step -1 dose : 1.0x10^6cells/kg Step 1 dose : 2.0x10^6cells/kg Step 2 dose : 3.0x10^6cells/kg The single injection of CS20AT04 Inj. in the peripheral veins.(IV) The duration of follow up study following the single dose of CS20AT04 is 28 days
| Study group | Role | What they receive |
|---|---|---|
| CS20AT04 | Experimental | Test group : CS20AT04 (allogenic bone marrow derived mesenchymal stem cells.) Receives: Biological: allogenic bone marrow derived mesenchymal stem cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety assessment(evaluation)
Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG
Measured: 28 days after administration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2017
- Study start30 May 2017
- Primary completion12 Mar 2019
- Study completion19 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Lupus NephritisStudies 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
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corestemchemon, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hanyang University
- Responsible party
- Sponsor
- Investigators
- SANG-CHEOL BAE, Principal investigator, Hanyang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03174587
- Sponsor's protocol ID
- CS20AT04-LN101
- Status last verified
- Nov 2019
- First submitted
- 31 May 2017
- Last updated
- 20 Nov 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Jang E, Jeong M, Kim S, Jang K, Kang BK, Lee DY, Bae SC, Kim KS, Youn J. Infusion of Human Bone Marrow-Derived Mesenchymal Stem Cells Alleviates Autoimmune Nephritis in a Lupus Model by Suppressing Follicular Helper T-Cell Development. Cell Transplant. 2016;25(1):1-15. doi: 10.3727/096368915X688173. Epub 2015 May 13.
PubMed 25975931Shim JS, Sung YK, Joo YB, Lee HS, Bae SC. Prevalence and incidence of systemic lupus erythematosus in South Korea. Rheumatol Int. 2014 Jul;34(7):909-17. doi: 10.1007/s00296-013-2915-9. Epub 2013 Dec 10.
PubMed 24322455
Study at a glance
From the registry record, last updated by the sponsor on 20 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.
- ClinicalTrials.gov ID
- NCT03174587
- Acronym / sponsor ID
- CS20AT04-LN101
- Conditions
- Lupus Nephritis
- Keywords
- Systemic lupus erythematosus, HLA-haplo-matching, allogenic bone marrow derived mesenchymal stem cell, Phase 1 clinical trial
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Corestemchemon, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Hanyang University
- Study start
- 30 May 2017 (actual)
- Primary completion
- 12 Mar 2019 (actual)
- Study completion
- 19 Aug 2019 (actual)
- First posted
- 2 Jun 2017 (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 purpose of conducting phase 1 trial to evaluate the safety and tolerability of allogenic bone marrow-derived mesenchymal stem cells(CS20AT04) in subjects with lupus nephritis.
Evaluating DLT by IV injection according to dose-escalating in lupus nephritis patients.
Detailed description
Lupus is a representative autoimmune disease that affects the whole body. It is occurred by generation of autoantibody and immune complex due to abnormal activation of the immune cells on the basis of abnormal immune responses.
Although about 50% of lupus patients have lupus nephritis, there is no therapy product targeted for the lupus nephritis now.
We have performed the pre-clinical and clinical studies using allogenic bone marrow derived mesenchymal stem cells in SLE.
CS20AT04 has anti-inflammatory effects, controls activity of immune cells and reduces generation of autoantibodies. So, it is expected to have treatment effects of lupus nephritis.
The clinical trial was designed as a single center, open-label, phase 1 clinical trials.
If that subject's written informed consent form to participate in this clinical trial will be conducted the required examinations and tests in accordance with the study protocol within 56 days investigational drug administration.
Then, the register for each dose step. For the final 3 subjects in the inclusion / exclusion criteria and be administered a drug test.
Check the adverse events for more than four hours after administration of the investigational drug, and will determine whether the expression of adverse drug reaction(ADR) by the visit after 3 days, 7 days and 28 days.
Except for dose administration, all subject are tested in the same schedule. As a result of evaluating severity of AE divided into grades in accordance with the CTCAE (Version 4.0) standards.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CS20AT04 | Experimental | Biological: allogenic bone marrow derived mesenchymal stem cellsTest group : CS20AT04 (allogenic bone marrow derived mesenchymal stem cells.) |
Who may qualify
- Ages
- 18 to 69 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female Patients aged ≥18 years and < 70years.
- Patients with HLA-haplo-matched bone marrow donor is less than 70 years old.
- Clinical diagnosis of SLE by American College of Rheumatology (ACR) criteria.
- Patients had suffered from active renal disease in the past or patients has active renal disease now. Active renal disese should have include below.
- Patients can be immunosuppressive agent to , steroids, taking, such as anti-Malarials (hydroxychloroquine) in a certain capacity, during the test period, to maintain the same capacity before 4-weeks screening.
Key exclusion criteria (37 listed)
- Those who do not kidney disease for SLE.
- Patients with a history of hypersensitivity, such as heavy metal poisoning similar to drug testing and drug ingredients.
- Patients a history Major organs (kidney, liver, lung, heart) transplant or liver hematopoietic cells / transplant or during of scheduled transplantation clinical trial.
- patients a history of kidney dialysis or during of the scheduled dialysis clinical trials within 2 weeks prior to the screening.
- Tested positive for hepatitis B(HBsAg, Anti-HBcAB, HBV-DNA) and hepatitis C(Anti-HCV, HCV-RNA) \.
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 |
|---|---|---|
| allogenic bone marrow derived mesenchymal stem cellsAlso: CS20AT04Step -1 dose : 1.0x10^6cells/kg Step 1 dose : 2.0x10^6cells/kg Step 2 dose : 3.0x10^6cells/kg The single injection of CS20AT04 Inj. in the peripheral veins.(IV) The duration of follow up study following the single dose of CS20AT04 is 28 days | Biological | CS20AT04 |
Primary outcome
Safety assessment(evaluation)
Time frame: 28 days after administration
Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG
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 20 Nov 2019.
- Background: PubMed 25975931Jang E, Jeong M, Kim S, Jang K, Kang BK, Lee DY, Bae SC, Kim KS, Youn J. Infusion of Human Bone Marrow-Derived Mesenchymal Stem Cells Alleviates Autoimmune Nephritis in a Lupus Model by Suppressing Follicular Helper T-Cell Development. Cell Transplant. 2016;25(1):1-15. doi: 10.3727/096368915X688173. Epub 2015 May 13.
- Background: PubMed 24322455Shim JS, Sung YK, Joo YB, Lee HS, Bae SC. Prevalence and incidence of systemic lupus erythematosus in South Korea. Rheumatol Int. 2014 Jul;34(7):909-17. doi: 10.1007/s00296-013-2915-9. Epub 2013 Dec 10.
- Corestem Inc.Link provided by the sponsor.
- Hanyang University Medical CenterLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
SANG-CHEOL BAE principal investigator
Hanyang University
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 allogenic bone marrow derived mesenchymal stem cells in people with Lupus Nephritis, run by Corestemchemon, Inc. 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 37 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 20 Nov 2019. 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 assessment(evaluation) (time frame: 28 days after administration). 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 NCT03174587, which also lists 2 linked publications.
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 20 Nov 2019.