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

NCT02594839 | Completed Phase 1 DMC

• 1 other identifier: ILD-01
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief 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

Idiopathic Interstitial Pneumonia; Interstitial Lung Disease; Idiopathic Pulmonary Fibrosis

Keywords

interstitial lung disease; idiopathic interstitial pneumonia; idiopathic pulmonary fibrosis; stem cells

Outcome Measures

Primary Outcomes (1)

• Safety: Number of serious adverse events

  registration of adverse events related to infusion and 12 months follow-up

  12 months

Secondary Outcomes (3)

• DLCO changes from baseline

  12 months

• FVC changes from baseline

  12 months

• exercise capacity changes

  12 months

Study Arms (2)

MSCs

EXPERIMENTAL

2 intravenous infusions of suspension of 200 000 000 MSCs each at interval of 7 days. Infusions will be repeated every 3 months for 1 year.

Drug: Bone marrow mesenchymal stem cells

placebo

PLACEBO COMPARATOR

2 intravenous infusions of 400 mL saline each at interval of 7 days. Infusions will be repeated every 3 months for 1 year.

Drug: Placebo

Interventions

Bone marrow mesenchymal stem cells DRUG

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

MSCs

Placebo DRUG

intravenous infusion of 400 mL saline

placebo

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients 20-80 years old
• Diagnosis of idiopathic interstitial pneumonia or secondary to connective tissue diseases interstitial lung disease, based on:
• Clinical symptoms \> 12 months duration,
• Histologically diagnosed or diagnostic chest HRCT features of interstitial pneumonia
• Forced Vital Capacity (FVC) ≥ 40% predicted and Diffusing Lung Capacity (DLCO) ≥20%
• Loss more than 10% of FVC (L) and DLCO during the last 12 months
• Signed informed consent.

You may not qualify if:

• Diagnosis of an interstitial lung disease other than idiopathic interstitial pneumonia or connective tissue disease associated with interstitial lung disease (sarcoidosis, pulmonary alveolar proteinosis, lymphangioleiomyomatosis, pulmonary amyloidosis, exposure-related lung disease etc)
• Obstructive lung disease: FEV1/FVC \< 0.70
• Clinically significant medical condition, in the opinion of the investigator, may compromise the results of the study
• Evidence of active infection within 4 week prior to enrollment
• History of malignancy \< 5 years prior to enrollment
• Unable to cooperate with any study procedures
• Pregnant or breast-feeding
• Treatment with antiinflammatory or antifibrotic drugs including oral steroids, cytostatic drugs, pirfenidone, D penicillamine, colchicine, tumor necrosis factor α blockers, imatinib, interferon γ, monoclonal antibodies \< 6 months prior to randomization.
• Active listing for transplant of any organ.
• Known history of alcohol abuse within 1 year prior to enrollment
• Participation in another clinical trial

Sponsors & Collaborators

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

Study Sites (1)

Federal Research Clinical Center FMBA of Russia

Moscow, 115682, Russia

Location

MeSH Terms

Conditions

Idiopathic Interstitial Pneumonias; Lung Diseases, Interstitial; Idiopathic Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases; Respiratory Tract Diseases

Study Design

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

Study Record Dates

• First Submitted: November 1, 2015
• First Posted: November 3, 2015
• Study Start: February 1, 2013
• Primary Completion: January 1, 2018
• Study Completion: January 1, 2018
• Last Updated: January 9, 2018

Record last verified: 2018-01

Locations

RU (1)