Lupus nephritis MedDRA version: 21.1 Level: PT Classification code 10025140 Term: Lupus nephritis System Organ Class: 10038359 - Renal and urinary disorders
Conditions
Interventions
Product Name: Allogeneic adult mesenchymal stem cells bone marrow derived expanded in suspension
Product Code: MSV®-allo
Pharmaceutical Form: Suspension for injection
INN or Proposed INN: células mese
Sponsors
Hospital Universitario Rio Hortega
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Females or males aged = 18 years who give written informed consent at the screening visit. 2. Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit. 3. Lupus Nephritis Diagnosis according to 2003 International Society of Nephrology and Renal Pathology Society classification, by biopsy performed no more than 6 months prior to the screening visit if including from the induction period and performed no more than 1 year if including with moderate/severe recurrence. 4. Non-response or partial response after 3 months of uninterrupted standard induction therapy treatment, or having started induction therapy during the screening period. Or moderate/severe recurrence of lupus nephritis during the maintenance phase. 5. SLEDAI-2K = 10 during the screening period. 6. Women of childbearing age must use effective methods of contraception to prevent pregnancy. 7. Have been vaccinated against pneumococcus and influenza at vaccination campaign time. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 20 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Previous treatments related: 1. Use of corticosteroids or mycophenolate above allowed doses for induction, according to Systemic Autoimmune Diseases Group of Internal Medicine Spanish Society and Nephrology Spanish Society Consensus Document. 2. Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening. 3. Use of cyclophosphamide at any time during 6 months prior to selection. 4. Use of any tumor necrosis factor inhibitor therapy at any time during 6 months prior to selection. 5. Use of immunoglobulins at any time during 6 months prior to selection. 6. Angiotensin-converting enzyme inhibitor or angiotensin receptor inhibitor dosis change during 2 months prior to selection. 7. Other investigational agent treatment during three months prior to screening or 5 times agent's half-life. Medical conditions related 1. Any medical condition, including an uncontrolled disease other than SLE, that, in investigator opinion, sponsor or designee, represents an inappropriate risk or trials participation contraindication or would interfere with trial objectives , conduct or evaluation. 2. Cardiac, peripheral or cerebrovascular cardiovascular episodes during 6 months prior to screening visit. 3. Active cardiac arrhythmia or significant ECG clinical abnormalities at screening visit or on randomization day which, according to investigator, sponsor, or designee opinion, constitute an inappropriate risk or contraindication to study participation. 4. Thromboembolic episodes 12 months prior to or at screening visit, whether or not related to associated antiphospholipid syndrome, or inadequate anticoagulation testing 6 weeks immediately prior to or during the screening visit. 5. Central nervous system SLE active considered severe or progressive (recent or uncontrolled seizures, anticonvulsant therapy changes in the 3 months prior to the screening visit, or leading to significant cognitive impairment). 6. Diagnosis of any demyelinating disease such as multiple sclerosis or optic neuritis. 8. Previous or plans for organ transplantation. 9. Active viral, bacterial or fungal infection clinically significant, or any major episode of infection which required hospitalization or parenteral treatment in 4 weeks prior to the screening visit, during the screening visit, or anti-infective treatment completion in the 2 weeks prior to or during the screening visit, or recurrent infections (three or more same type of infection cases in a period of 12 consecutive months). Vaginal candidiasis, onychomycosis and controlled genital or oral herpes simplex virus would not be reasons for exclusion. 10. History or positive result for human immunodeficiency virus (HIV) test, hepatitis C antibodies and/or polymerase chain reaction, hepatitis B surface antigen (HBsAg+), and/or total IgM antibodies to hepatitis B nuclear antigen at screening. 11. Diagnosis of active or latent tuberculosis by a purified protein derivative TB skin test (induration = 5 mm) or a positive Quantiferon test result, at screening or 3 months prior to the screening visit. Patients who have completed adequate prior treatment or who are receiving treatment will not repeat the test. Patients who are receiving adequate TB treatment for at least 4 continuous weeks prior to the screening visit and who are expected to complete the treatment regimen will not be excluded. 12. Presence of class 3 or 4 uncontrolled congestive heart failure according
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: 1. Time to achieve complete or partial remission after transplantation with MSV-allo®. 2. Time to maintain response. 3. Effect on corticosteroids use reduction during induction period. 4. Effect on immunosuppressants use reduction during induction period. 5. Safety, tolerability and immunogenicity profiles of MSV-allo® in Lupus nephritis patients. 6. MSV-allo® effect on pacients life quality.;Main Objective: Safety and efficacy assessing of MSV-allo® compared to placebo to achieve complete or parcial lupus nephritis remision after the indution period;Primary end point(s): Patients proportion with reduced renal and SLE activity at week 24, compared with placebo.;Timepoint(s) of evaluation of this end point: 24 weeks after the screening visit. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Patients proportion at week 24 whose prednisone-equivalent corticosteroid dose was reduced relative to the screening visit. 2. Patients proportion at week 24 whose immunosuppressants dose has been reduced relative to the screening visit. 3. Reduction by at least 4 points in the SLEDAI-2K index at week 24 after IMP administration. 4. Time taken to achieve complete remission after IMP administration.;Timepoint(s) of evaluation of this end point: 24 weeks after the screening visit. | — |
Countries
Spain
Contacts
Public ContactRosa Conde
Hospital Universitario Rio Hortega
Outcome results
None listed