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Completed

NCT Number: NCT04184258

Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

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Key information

Conditions

Systemic Lupus Erythematosus Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Lupus Erythematosus, Systemic Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • SLE diagnosis (4 of 11 criteria by ACR);
  • positive dsDNA;
  • SELENA-SLEDAI index ≥6;
  • active lupus nephritis;
  • patient can read, understand and follow the procedures.

Exclusion criteria

  • need for dialysis;
  • planned renal transplantation;
  • any medical condition which can be associated with the high risk for the patient;
  • pregnancy/lactation;
  • chronic infections, including hepatitis B/C, tuberculosis, HIV;
  • any malignant tumor in the last 5 years.

Treatment and study plan

Pooled mesenchymal stem cell

Biological

Pooled allogenic mesenchymal stem cell derived from olfactory mucosa

Standard treatment according to the Clinical protocols

Other

Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus

Primary outcomes

  1. Efficacy evaluation

    Time frame: 6 month

    Efficacy evaluation (SELENA-SLEDAI)

Secondary outcomes

  1. Safety eveluation

    Time frame: 1 month

    Absence of adverse reactions

Sponsors and collaborators

Lead sponsor

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Other Gov

Collaborators

  • Belarusian State Medical University

Registry information

Official study title

Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Dec 3, 2019
Registry last updated
Jan 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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