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Evaluate the Safety of CS20AT04 Inj. in Subjects With Lupus Nephritis

NCT03174587 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 7

Last updated 2019-11-20

No results posted yet for this study

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.

Conditions

Interventions

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

Sponsors & Collaborators

  • Hanyang University

    collaborator OTHER

  • Corestemchemon, Inc.

    lead INDUSTRY

Principal Investigators

  • SANG-CHEOL BAE · Hanyang University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
69 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-05-30
Primary Completion
2019-03-12
Completion
2019-08-19

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03174587 on ClinicalTrials.gov