Treatment of Systemic Lupus Erythematosus With Pooled Allogenic Mesenchymal Stem Cells

NCT ID: NCT04184258

Last Updated: 2021-01-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

7 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-12-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

Treatment of systemic lupus erythematosus with pooled allogenic mesenchymal stem cells

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Systemic Lupus Erythematosus

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

SLE patients MSC treatment

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

Group Type EXPERIMENTAL

Pooled mesenchymal stem cell

Intervention Type BIOLOGICAL

Pooled allogenic mesenchymal stem cell derived from olfactory mucosa

Standard treatment according to the Clinical protocols

Intervention Type OTHER

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

SLE patients standard treatment

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

Group Type ACTIVE_COMPARATOR

Standard treatment according to the Clinical protocols

Intervention Type OTHER

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Pooled mesenchymal stem cell

Pooled allogenic mesenchymal stem cell derived from olfactory mucosa

Intervention Type BIOLOGICAL

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

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Belarusian State Medical University

OTHER

Sponsor Role collaborator

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

OTHER_GOV

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Andrei Hancharou, Dr

Role: STUDY_DIRECTOR

Director, the Institute of Biophysics and Cell Engineering of National Academy of Sciences of Belarus

Konstantin A Chizh, Dr

Role: STUDY_DIRECTOR

Associate professor, Belarusian State Medical University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Minsk, , Belarus

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Belarus

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

IBCE_MSC1(SLE)

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.