Back to resultsTreatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
Primary Purpose
Systemic Lupus Erythematosus
Status
Completed
Phase
Phase 1
Locations
Belarus
Study Type
Interventional
Intervention
Pooled mesenchymal stem cell
Standard treatment according to the Clinical protocols
Sponsored by
About this trial
This is an interventional treatment trial for Systemic Lupus Erythematosus focused on measuring Systemic Lupus Erythematosus, mesenchymal stem cells
Eligibility 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.
Sites / Locations
- Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
SLE patients MSC treatment
SLE patients standard treatment
Arm Description
Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
Patients with SLE, who receive standard treatment according to the Clinical protocols
Outcomes
Primary Outcome Measures
Efficacy evaluation
Efficacy evaluation (SELENA-SLEDAI)
Secondary Outcome Measures
Safety eveluation
Absence of adverse reactions
Full Information
NCT ID
NCT04184258
First Posted
December 1, 2019
Last Updated
January 20, 2021
Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
1. Study Identification
Unique Protocol Identification Number
NCT04184258
Brief Title
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
Official Title
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Collaborators
Belarusian State Medical University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Systemic Lupus Erythematosus
Keywords
Systemic Lupus Erythematosus, mesenchymal stem cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
7 (Actual)
8. Arms, Groups, and Interventions
Arm Title
SLE patients MSC treatment
Arm Type
Experimental
Arm Description
Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols
Arm Title
SLE patients standard treatment
Arm Type
Active Comparator
Arm Description
Patients with SLE, who receive standard treatment according to the Clinical protocols
Intervention Type
Biological
Intervention Name(s)
Pooled mesenchymal stem cell
Intervention Description
Pooled allogenic mesenchymal stem cell derived from olfactory mucosa
Intervention Type
Other
Intervention Name(s)
Standard treatment according to the Clinical protocols
Intervention Description
Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus
Primary Outcome Measure Information:
Title
Efficacy evaluation
Description
Efficacy evaluation (SELENA-SLEDAI)
Time Frame
6 month
Secondary Outcome Measure Information:
Title
Safety eveluation
Description
Absence of adverse reactions
Time Frame
1 month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrei Hancharou, Dr
Organizational Affiliation
Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Konstantin A Chizh, Dr
Organizational Affiliation
Associate professor, Belarusian State Medical University
Official's Role
Study Director
Facility Information:
Facility Name
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
City
Minsk
ZIP/Postal Code
220072
Country
Belarus
12. IPD Sharing Statement
Learn more about this trial
Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells
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