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“A Phase II, double-blinded, placebo-controlled clinical trial to evaluate the safety and efficacy of mesenchymal cells (MSV-ALLO®) in the treatment of lupus nephritis”
EU CTIS ID: 2024-514750-67-00
What this study is testing
General: The main objective of this trial is to evaluate the safety and efficacy of MSV-allo® compared to placebo in obtaining complete or partial remission in active LN. Principal: Proportion of patients achieving complete or partial response at week 24, relative to baseline, in the treatment group compared to the placebo group .
- Phase II and Phase III (Integrated)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Females or males aged ≥ 18 years who give written informed consent at the screening visit.
- Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit.
- 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.
- No response, or partial response, to standard treatment, or moderate/severe recurrence of lupus nephritis
- SLEDAI-2K # 10 during the screening period
- Women of childbearing age must use effective methods of contraception to prevent pregnancy
You likely can't join if
- *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.
- 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 to the New York Heart Association
- 2.- Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening
- 13. Active cancer
- 14. Major surgical intervention within 6 weeks prior to the screening visit or planned during the trial period, including follow-up.
See the full eligibility criteria
Who can join
- Females or males aged ≥ 18 years who give written informed consent at the screening visit.
- Systemic Lupus Erythematosus Diagnosis by meeting at least 4 criteria of the 11 included in ACR classification and/or SLICC criteria, at screening visit.
- 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.
- No response, or partial response, to standard treatment, or moderate/severe recurrence of lupus nephritis
- SLEDAI-2K # 10 during the screening period
- Women of childbearing age must use effective methods of contraception to prevent pregnancy
- Have been vaccinated against pneumococcus and influenza at vaccination campaign time
What rules you out
- *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.
- 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 to the New York Heart Association
- 2.- Use of rituximab, belimumab, ocrelizumab or other biological therapies against B cells 6 months prior to screening
- 13. Active cancer
- 14. Major surgical intervention within 6 weeks prior to the screening visit or planned during the trial period, including follow-up.
- 15. Pregnant or lactating women
- 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.- 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
- 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.
- 7.- Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease
- *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.
- *Laboratory abnormalities 1. Clinically significant abnormalities in laboratory tests not attributed to active SLE
- 2. Chest X-ray significant abnormalities indicating active TB. The chest x-ray must have been done within 3 months prior to the screening visit or during the screening period.
- *Other 1. Legal incapacity
- 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.
- 7.Comorbidities that require treatment with systemic corticosteroids (oral, rectal or injectable) such as asthma or inflammatory bowel disease
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.