Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Overview

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Full Title of Study: “Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 31, 2020

Interventions

  • Biological: Pooled mesenchymal stem cell
    • Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
  • Other: Standard treatment according to the Clinical protocols
    • Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus

Arms, Groups and Cohorts

  • Experimental: SLE patients MSC treatment
    • Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
  • Active Comparator: SLE patients standard treatment
    • Patients with SLE, who receive standard treatment according to the Clinical protocols

Clinical Trial Outcome Measures

Primary Measures

  • Efficacy evaluation
    • Time Frame: 6 month
    • Efficacy evaluation (SELENA-SLEDAI)

Secondary Measures

  • Safety eveluation
    • Time Frame: 1 month
    • Absence of adverse reactions

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
  • Collaborator
    • Belarusian State Medical University
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Andrei Hancharou, Dr, Study Director, Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
    • Konstantin A Chizh, Dr, Study Director, Associate professor, Belarusian State Medical University
  • Overall Contact(s)
    • Andrei Y Hancharou, Dr, +375296248972, andrei.hancharou@gmail.com

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