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Safety and efficacy of umbilical cord blood-derived mononuclear cells in the treatment of refractory membranous nephropathy

Safety and efficacy of umbilical cord blood-derived mononuclear cells in the treatment of refractory membranous nephropathy

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2400083681
Enrollment
Unknown
Registered
2024-04-30
Start date
2024-05-01
Completion date
Unknown
Last updated
2024-05-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

refractory membranous nephropathy

Interventions

Trial group:Standardized treatment combined with intravenous transfusion of umbilical cord blood-derived mononuclear cells
Control group:Standardized treatment with corticosteroids and immunosuppressants

Sponsors

Tai'an Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

Inclusion criteria: (1) Age = 18 years old. Renal biopsy pathologically confirmed membranous nephropathy or elevated serological anti-phospholipase A2 receptor antibody titers; (2) Patients who have received first-line immunosuppressant therapy such as steroids, cyclophosphamide, and tacrolimus for 3 months, and have not achieved partial or complete response; (3) Patients with positive anti-PLA2R antibody persisted serum anti-PLA2R antibody (not negative or improved) after receiving immunosuppressive therapy; (4) Patients who voluntarily participate in the study and sign informed consent; (5) Patients who are willing and able to carry out treatment and follow-up according to the requirements of the protocol, and can follow the doctor's instructions for basic treatment.

Exclusion criteria

Exclusion criteria: (1) eGFR<30 ml·min?¹·(1.73 m²)?¹; (2) Patients with secondary membranous nephropathy; (3) Patient with active hepatitis; (4) Patients with malignant tumors, severe infections, tuberculosis and dysfunction of organs such as heart, lung, and liver; (5) Patients with mental illness who cannot cooperate with treatment; (6) Pregnant or lactating women.

Design outcomes

Primary

MeasureTime frame
24-hour urinary protein quantification;Serum albumin;Gomerular filtration rate;Serum anti-PLA2R antibody;

Secondary

MeasureTime frame
Safety;Blood lipids;Routine urine test;IgG, IgA, IgM, serum cytokines, and lymphocyte subsets;

Countries

China

Contacts

Public ContactWang Liya

Tai'an Central Hospital

liya_dr@126.com+86 538 629 8472

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026