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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04184258
Other study ID # IBCE_MSC1(SLE)
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received
Last updated
Start date July 1, 2019
Est. completion date December 31, 2020

Study information

Verified date January 2021
Source Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells


Recruitment information / eligibility

Status Completed
Enrollment 7
Est. completion date December 31, 2020
Est. primary completion date December 31, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Intervention

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

Locations

Country Name City State
Belarus Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Minsk

Sponsors (2)

Lead Sponsor Collaborator
Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus Belarusian State Medical University

Country where clinical trial is conducted

Belarus, 

Outcome

Type Measure Description Time frame Safety issue
Primary Efficacy evaluation Efficacy evaluation (SELENA-SLEDAI) 6 month
Secondary Safety eveluation Absence of adverse reactions 1 month
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