Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis
|ClinicalTrials.gov Identifier: NCT03174587|
Recruitment Status : Enrolling by invitation
First Posted : June 2, 2017
Last Update Posted : August 8, 2017
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.
|Condition or disease||Intervention/treatment||Phase|
|Lupus Nephritis||Biological: allogenic bone marrow derived mesenchymal stem cells||Phase 1|
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 Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||6 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase 1 Study to Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis.|
|Actual Study Start Date :||May 30, 2017|
|Estimated Primary Completion Date :||June 30, 2018|
|Estimated Study Completion Date :||July 30, 2018|
Test group : CS20AT04 (allogenic bone marrow derived mesenchymal stem cells.)
Biological: allogenic bone marrow derived mesenchymal stem cells
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
Other Name: CS20AT04
- Safety assessment(evaluation) [ Time Frame: 28 days after administration ]Adverse events(AE), Laboratory test(hematology/blood chemistry, urine test), Vital signs, Physical examination, ECG
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03174587
|Korea, Republic of|
|Hanyang university hospital|
|Seoul, Korea, Republic of, 04763|
|Principal Investigator:||SANG-CHEOL BAE||Hanyang University|