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Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease

NCT02594839 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2018-01-09

No results posted yet for this study

Summary

The study evaluates the safety and the efficacy of the addition of intravenous transplantation of donor bone marrow mesenchymal stem cells in patients with idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease, which have actively progressing disease with rapid loss of pulmonary function on the background of routine treatment.

Conditions

Interventions

DRUG

Bone marrow mesenchymal stem cells

Bone marrow will be harvested in healthy donors followed by separation and cultivation of MSCs. Before infusion cells will be suspended in 400 mL saline

DRUG

Placebo

intravenous infusion of 400 mL saline

Sponsors & Collaborators

  • Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

    lead OTHER_GOV

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-02-28
Primary Completion
2018-01-31
Completion
2018-01-31

Countries

  • Russia

Study Locations

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Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02594839 on ClinicalTrials.gov