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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Phase I-II Study to Evaluate Safety and Efficacy of Allogeneic Bone-Marrow Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02594839
• Other study ID #: ILD-01
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 1, 2015
• Last updated: January 8, 2018
• Start date: February 2013
• Est. completion date: January 2018

Study information

• Verified date: January 2018
• Source: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Despite significant progress in the treatment of interstitial lung disease, achieved thanks to new drugs, such as pirfenidone and nintedanib, there are many patients for whom these drugs are not available or poorly tolerated. In addition significant evidence of their effectiveness and safety is valid only for idiopathic pulmonary fibrosis. The transplantation of allogeneic stem cells is a promising direction in the modern medicine with the proven safety for different diseases. But the effectiveness of this therapy is still under research. We believe that in most severe cases of a rapidly progressive interstitial lung disease the transplantation of mesenchymal stem cells may be an effective technology due to their immunomodulatory properties.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2018
• Est. primary completion date: January 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 a blockers, imatinib, interferon ?, 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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonia
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Interstitial Lung Disease
• Lung Diseases
• Lung Diseases, Interstitial
• Pneumonia
• Pulmonary Fibrosis

Intervention

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
• Placebo
intravenous infusion of 400 mL saline

Locations

Country	Name	City	State
Russian Federation	Federal Research Clinical Center FMBA of Russia	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety: Number of serious adverse events	registration of adverse events related to infusion and 12 months follow-up	12 months
Secondary	DLCO changes from baseline	Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment	12 months
Secondary	FVC changes from baseline	Assessment of spirometry at 3, 6, 9, 12 months of treatment	12 months
Secondary	exercise capacity changes	Assessment of 6MWD at 3, 6, 9, 12 months of treatment	12 months