Investigator-initiated trial to evaluate the efficacy and safety of autologous bone marrow-derived mesenchymal stem cells for treatment of lupus nephritis or lupus cytopenia

Open-label, single-arm, 24-week investigator study to evaluate the efficacy and safety of CS20AT04 administered in patients with lupus nephritis or lupus cytopenia

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

CRIS

Registry ID

KCT0004337

Enrollment

Registered

2019-10-16

Start date

2019-11-15

Completion date

Unknown

Last updated

2019-11-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Biological/Vaccine, Stem Cell : 2 times IV injection of Allogenic Bone marrow driven mesenchymal stem cell in 3 months interval

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: (1) Patients who have received any investigational product (small molecule or biological agent) within 4 weeks or 5 half-lives prior to baseline, whichever is greater (2) Patients who have received any commercially available biologic agent within 5 half-lives prior to baseline (3) Patient who have a history of an anaphylaxis reaction to parenteral administration of contrast agents, human or murine proteins, or monoclonal antibodies (4) Patients who have received any of the following within 6 months prior to baseline o Nitrogen mustard, chlorambucil, vincristine, procarbazine o Abatacept o Rituximab, belimumab (5) Patients who have received any of the following within 3 months prior to baseline o Anti-TNF therapy(etanercept, adalimumab, infliximab, golimumab, tocilizumab) o Interleukin-1 receptor antagonist(anakinra) o Intravenous immunoglobulin(IVIG) o Plasmapheresis (6) Patients with hypersensitivity to antibiotics of penicillin and streptomycin (7) Patient with an estimated glomerular filtration rate less than 30ml/min at screening (8) Patients with history of Stem Cells Therapy (9) Patients who determined by the investigators to be inappropriate

Exclusion criteria

Exclusion criteria: (1) Patients with HLA-haplo-matched bone marrow donor aged 18 – 70 years old (inclusive) (2) Patients meeting: o at least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, including at least 1 clinical criterion and 1 immunology criterion; or o at least 4 of the 11 Revised American College of Rheumatology (ACR) Criteria for Classification of Systemic Lupus Erythematosus, according to the 1997 Update of the 1982 ACR (3) Patients having a positive test result for antinuclear antibody (ANA; titer at least 1:80) and/or anti-double stranded DNA antibody (anti-dsDNA Ab) at screening (4) Patients (non-responder or partial responder), defined as: o unresponsive to treatment with standard care, or o with continued daily dosage of =15mg of prednisone or its equivalent for maintenance treatment (5) (For lupus cytopenia subpopulation only) Patients with refractory cytopenia (at least one of anemia, leukopenia, or thrombocytopenia) in absence of any other identifiable cause (6) (For lupus nephritis subpopulation only) Patients with clinical disease activity of lupus nephritis

Design outcomes

Primary

Measure	Time frame
Tapering of corticosteroids with improvement in lupus nephritis or cytopenia	—

Secondary

Measure	Time frame
Safety of CS20AT04	—

Countries

Korea, Republic of

Contacts

Public ContactChan-Bum Choi

Hanyang University Seoul Hospital

cbchoi@gmail.com+82-2-2290-9240

Outcome results