Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

Systemic Lupus Erythematosus Clinical Trial

Official title:

Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Olfactory Mucosa Derived Mesenchymal Stem Cells

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04184258
• Other study ID #: IBCE_MSC1(SLE)
• Status: Completed
• Phase: Phase 1/Phase 2
• 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
• 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.

Related Conditions & MeSH terms

• Lupus Erythematosus, Systemic
• Systemic Lupus Erythematosus

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