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Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04184258
Recruitment Status : Recruiting
First Posted : December 3, 2019
Last Update Posted : July 7, 2020
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Tracking Information
First Submitted Date  ICMJE December 1, 2019
First Posted Date  ICMJE December 3, 2019
Last Update Posted Date July 7, 2020
Actual Study Start Date  ICMJE July 1, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 1, 2019)
Efficacy evaluation [ Time Frame: 6 month ]
Efficacy evaluation (SELENA-SLEDAI)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: December 1, 2019)
Safety eveluation [ Time Frame: 1 month ]
Absence of adverse reactions
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
Official Title  ICMJE Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
Brief Summary Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Systemic Lupus Erythematosus
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
    Interventions:
    • Biological: Pooled mesenchymal stem cell
    • Other: 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
    Intervention: Other: Standard treatment according to the Clinical protocols
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: December 1, 2019)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Andrei Y Hancharou, Dr +375296248972 andrei.hancharou@gmail.com
Contact: Natalia G Antonevich, Dr +375295987406 antonevich.n@gmail.com
Listed Location Countries  ICMJE Belarus
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04184258
Other Study ID Numbers  ICMJE IBCE_MSC1(SLE)
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study Sponsor  ICMJE Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators  ICMJE Belarusian State Medical University
Investigators  ICMJE
Study Director: Andrei Hancharou, Dr Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Study Director: Konstantin A Chizh, Dr Associate professor, Belarusian State Medical University
PRS Account Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP