Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT03673748

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

Led by Red de Terapia Celular · Updated on 2025-07-24

20

Participants Needed

1

Research Sites

257 weeks

Total Duration

On this page

Sponsors

R

Red de Terapia Celular

Lead Sponsor

H

Hospital del Rio Hortega

Collaborating Sponsor

AI-Summary

What this Trial Is About

The purpose of this study is to evaluate the safety and efficacy of mesenchymal stem cells (MSCs) obtained from bone marrow for the treatment of adults with active proliferative lupus nephritis. The objective of this study is to evaluate the efficacy of mesenchymal stem cells (MSCs) in achieving a full or partial response in the treatment of Lupus Nephritis (LN) during its induction period.

CONDITIONS

Official Title

Treatment of Lupus Nephritis With Allogeneic Mesenchymal Stem Cells

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Females or males aged 18 years or older who provide written informed consent.
  • Diagnosis of systemic lupus erythematosus by meeting at least 4 of 11 criteria from ACR or SLICC.
  • Diagnosis of lupus nephritis confirmed by kidney biopsy within 6 months before selection or within one year if moderate/severe recurrence.
  • No response or partial response to standard lupus nephritis treatment or moderate/severe recurrence.
  • SLEDAI-2K score of 10 or higher during selection.
  • Women of childbearing potential must use effective contraception.
  • Vaccinated against pneumococcus and influenza during vaccination campaigns.
Not Eligible

You will not qualify if you...

  • Use of corticosteroids or mycophenolate above allowed induction doses.
  • Use of rituximab, belimumab, ocrelizumab, or other B-cell biologics within 6 months.
  • Use of cyclophosphamide within 6 months.
  • Use of tumor necrosis factor inhibitors within 6 months.
  • Use of immunoglobulins within 6 months.
  • Change in angiotensin converting enzyme or receptor inhibitor doses within 2 months.
  • Treatment with another investigational drug within 3 months or 5 half-lives.
  • Any uncontrolled or contraindicating disease other than SLE posing risk.
  • Cardiac, peripheral, or cerebrovascular events within 6 months.
  • Active arrhythmia or significant ECG abnormalities posing risk.
  • Thromboembolic events within 12 months or inadequate anticoagulation.
  • Severe or progressive central nervous system lupus.
  • History or diagnosis of demyelinating diseases like multiple sclerosis.
  • Comorbidities requiring systemic corticosteroids such as asthma or inflammatory bowel disease.
  • History or plans for organ transplant.
  • Active significant infections or recent major infections requiring hospitalization or IV treatment.
  • Positive HIV, hepatitis C, or hepatitis B tests.
  • Active or latent tuberculosis unless adequately treated.
  • Class 3 or 4 uncontrolled congestive heart failure.
  • Active cancer.
  • Major surgery within 6 weeks prior or planned.
  • Pregnant or lactating women.
  • Significant laboratory abnormalities not due to SLE.
  • Chest X-ray showing active tuberculosis within 3 months.
  • Legal incapacity.

AI-Screening

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Trial Site Locations

Total: 1 location

1

University Hospital Río Hortega

Valladolid, Valladolid, Spain, 47012

Actively Recruiting

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Research Team

J

Julia Barbado, MD, PhD

CONTACT

M

Margarita González-Vallinas, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

TRIPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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