NCT04184258

Brief Summary

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for phase_1

Timeline
Completed

Started Jul 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2019

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

December 1, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 3, 2019

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

January 22, 2021

Status Verified

January 1, 2021

Enrollment Period

1.5 years

First QC Date

December 1, 2019

Last Update Submit

January 20, 2021

Conditions

Systemic Lupus Erythematosus

Keywords

Systemic Lupus Erythematosusmesenchymal stem cells

Outcome Measures

Primary Outcomes (1)

  • Efficacy evaluation

    Efficacy evaluation (SELENA-SLEDAI)

    6 month

Secondary Outcomes (1)

  • Safety eveluation

    1 month

Study Arms (2)

SLE patients MSC treatment

EXPERIMENTAL

Patients with SLE, who receive pooled mesenchymal stem cells in addition to the standard treatment according to the Clinical protocols

Biological: Pooled mesenchymal stem cellOther: Standard treatment according to the Clinical protocols

SLE patients standard treatment

ACTIVE COMPARATOR

Patients with SLE, who receive standard treatment according to the Clinical protocols

Other: Standard treatment according to the Clinical protocols

Interventions

Pooled mesenchymal stem cellBIOLOGICAL

Pooled allogenic mesenchymal stem cell derived from olfactory mucosa

SLE patients MSC treatment
Standard treatment according to the Clinical protocolsOTHER

Standard SLE treatment according to the Clinical protocols approved by the Ministry of healthcare of Republic of Belarus

SLE patients MSC treatmentSLE patients standard treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Minsk, 220072, Belarus

Location

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesAutoimmune DiseasesImmune System Diseases

Study Officials

  • 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

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 1, 2019

First Posted

December 3, 2019

Study Start

July 1, 2019

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

January 22, 2021

Record last verified: 2021-01

Locations

BE(1)