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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 : December 4, 2019
Sponsor:
Collaborator:
Belarusian State Medical University
Information provided by (Responsible Party):
Andrei Y. Hancharou, Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Brief Summary:
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Condition or disease Intervention/treatment Phase
Systemic Lupus Erythematosus Biological: Pooled mesenchymal stem cell Other: Standard treatment according to the Clinical protocols Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lupus

Arm Intervention/treatment
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
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

Active Comparator: SLE patients standard treatment
Patients with SLE, who receive standard treatment according to the Clinical protocols
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




Primary Outcome Measures :
  1. Efficacy evaluation [ Time Frame: 6 month ]
    Efficacy evaluation (SELENA-SLEDAI)


Secondary Outcome Measures :
  1. Safety eveluation [ Time Frame: 1 month ]
    Absence of adverse reactions



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04184258


Contacts
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Contact: Andrei Y Hancharou, Dr +375296248972 andrei.hancharou@gmail.com
Contact: Natalia G Antonevich, Dr +375295987406 antonevich.n@gmail.com

Locations
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Belarus
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Recruiting
Minsk, Belarus, 220072
Contact: Andrei Y Hancharou, Dr    375296248972    andrei.hancharou@gmail.com   
Contact: Natalia G Antonevich, Dr    +375295987406    antonevich.n@gmail.com   
Sponsors and Collaborators
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Belarusian State Medical University
Investigators
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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

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Responsible Party: Andrei Y. Hancharou, Director, Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
ClinicalTrials.gov Identifier: NCT04184258    
Other Study ID Numbers: IBCE_MSC1(SLE)
First Posted: December 3, 2019    Key Record Dates
Last Update Posted: December 4, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Andrei Y. Hancharou, Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus:
Systemic Lupus Erythematosus
mesenchymal stem cells
Additional relevant MeSH terms:
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Lupus Erythematosus, Systemic
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases