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
- Conditions
- Diseases of the musculo-skeletal system and connective tissue
- Registration Number
- KCT0004337
- Lead Sponsor
- Hanyang University Seoul Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 8
(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
oNitrogen mustard, chlorambucil, vincristine, procarbazine
oAbatacept
oRituximab, 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
(1)Patients with HLA-haplo-matched bone marrow donor aged 18 – 70 years old (inclusive)
(2)Patients meeting:
oat least 4 of the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria, including at least 1 clinical criterion and 1 immunology criterion; or
oat 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:
ounresponsive to treatment with standard care, or
owith 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
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Tapering of corticosteroids with improvement in lupus nephritis or cytopenia
- Secondary Outcome Measures
Name Time Method Safety of CS20AT04