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Exploring the Efficacy and Safety of CS20AT04 (Allogenic Bone Marrow-Derived Stem Cell) in Systemic Lupus Erythematosus Patients

NCT04835883 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-08

No results posted yet for this study

Summary

This is an open-label, one-arm single-center phase Ⅱa study exploring the efficacy and safety of CS20AT04 (HLA-haplo Matched Allogenic Bone Marrow-Derived Stem Cells) in two subpopulation group of systemic lupus erythematosus patients - lupus nephritis and lupus cytopenia.

Conditions

Interventions

BIOLOGICAL

CS20AT04 (allogenic bone marrow derived mesenchymal stem cell)

Two intravenous infusions of CS20AT04 (2.0×10\^6cell/kg), on 0 day and on 12 weeks The target population of this study is subjects in South Korea with a diagnosis of either lupus nephritis or lupus cytopenia.

Sponsors & Collaborators

  • Corestemchemon, Inc.

    collaborator INDUSTRY

  • Ministry of Health & Welfare, Korea

    collaborator OTHER_GOV

  • Hanyang University Seoul Hospital

    lead OTHER

Principal Investigators

  • Chan-Bum Choi, M.D.,Ph.D. · Department of Rhumatology in Hanyang University Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2019-09-26
Primary Completion
2021-11-05
Completion
2026-01-20

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 NCT04835883 on ClinicalTrials.gov