Phase 2 Study of Human Umbilical Cord Derived Mesenchymal Stem Cell for the Treatment of Lupus Nephritis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The efficacy measure of hUC-MSC in the treatment of proliferative lupus nephritis on remission of lupus nephritis (combined partial and complete remission) in terms of stabilization and improvement in renal function.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Allogeneic Amniotic Mesenchymal Stem Cell Therapy for Lupus Nephritis

NCT04318600

Lupus Nephritis Mesenchymal Stem Cells

COMPLETED PHASE1

MSC303 Subcutaneous Injection for the Treatment of Immunologic Glomerular Disease.

NCT07000292

Lupus Nephritis (LN) ANCA-Associated Glomerulonephritis

NOT_YET_RECRUITING PHASE1/PHASE2

MMF Versus CYC in the Induction Therapy of Pediatric Active Proliferative LN

NCT05495893

Mycophenolate Mofetil Cyclophosphamide Lupus Nephritis

UNKNOWN PHASE4

MMF Versus CTX in the Induction Treatment of ANCA Associated Vasculitis

NCT00301652

Vasculitis Anti-Neutrophil Cytoplasmic Antibody

COMPLETED NA

Study on Pharmacokinetics of Meperizumab Injection and NUCALA® in Healthy Male Volunteers

NCT05353179

Granulomatosis With Polyangiitis Hemophagocytic Syndrome

UNKNOWN EARLY_PHASE1

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Inclusion criteria:

1. Male or non-pregnant females age 16 to 65 years inclusive.
2. Written informed consent obtained from patient or parents/guardian.
3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B.
4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lupus Nephritis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Human Umbilical Cord derived MSCs

Group Type EXPERIMENTAL

Human Umbilical Cord derived MSCs

Intervention Type BIOLOGICAL

Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion

Cyclophosphamide

Group Type PLACEBO_COMPARATOR

Cyclophosphamide

Intervention Type DRUG

Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Human Umbilical Cord derived MSCs

Human Umbilical Cord derived MSCs treatment for lupus nephritis via infusion

Intervention Type BIOLOGICAL

Cyclophosphamide

Cyclophosphamide based immunosuppressive agent for treatment for lupus nephritis

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Allogeneic stem cells derived from umbilical cord Immunosupressive agent

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Male or non-pregnant females age 16 to 65 years inclusive.
2. Written informed consent obtained from patient or parents/guardian.
3. Patients with SLE fulfilling American Rheumatism Association criteria and SLEDAI score\>8 or BILAG score A/B.
4. Patients with newly diagnosed World Health Organization (WHO) Class III or IV Lupus Nephritis

Exclusion Criteria

Patients with any of the following are not eligible for enrollment into the study:

1. Pregnant or nursing woman or women of childbearing potential except if post-menopausal, surgically sterile or using accepted method(s) of birth control or having negative pregnancy test.
2. Participation in any research in which the patient received an investigational product within 30 days preceding the screening phase of this study.
3. Those persons directly involved in the conduct of the study.
4. Serum creatinine more than 250 µmol/L.
5. White blood cell (WBC) count of less than 3.5 X 109/L.
6. Active peptic ulcer disease.
7. Active systemic infection.
8. History of alcohol or substance abuse.
9. History of malignancy within previous 5 years.
10. Any serious medical conditions or disability, which in the opinion of the investigator, would interfere with treatment or assessment or preclude completion of this study.

Minimum Eligible Age

16 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No