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

Primary Purpose

Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
Russian Federation
Study Type
Interventional
Intervention
Bone marrow mesenchymal stem cells
Placebo
Sponsored by
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Interstitial Pneumonia focused on measuring interstitial lung disease, idiopathic interstitial pneumonia, idiopathic pulmonary fibrosis, stem cells

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 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

Sites / Locations

  • Federal Research Clinical Center FMBA of Russia

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

MSCs

placebo

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Safety: Number of serious adverse events
registration of adverse events related to infusion and 12 months follow-up

Secondary Outcome Measures

DLCO changes from baseline
Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment
FVC changes from baseline
Assessment of spirometry at 3, 6, 9, 12 months of treatment
exercise capacity changes
Assessment of 6MWD at 3, 6, 9, 12 months of treatment

Full Information

First Posted
November 1, 2015
Last Updated
January 8, 2018
Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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1. Study Identification

Unique Protocol Identification Number
NCT02594839
Brief Title
Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
January 2018 (Actual)
Study Completion Date
January 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis
Keywords
interstitial lung disease, idiopathic interstitial pneumonia, idiopathic pulmonary fibrosis, stem cells

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MSCs
Arm Type
Experimental
Arm Description
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.
Arm Title
placebo
Arm Type
Placebo Comparator
Arm Description
2 intravenous infusions of 400 mL saline each at interval of 7 days. Infusions will be repeated every 3 months for 1 year.
Intervention Type
Drug
Intervention Name(s)
Bone marrow mesenchymal stem cells
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
intravenous infusion of 400 mL saline
Primary Outcome Measure Information:
Title
Safety: Number of serious adverse events
Description
registration of adverse events related to infusion and 12 months follow-up
Time Frame
12 months
Secondary Outcome Measure Information:
Title
DLCO changes from baseline
Description
Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment
Time Frame
12 months
Title
FVC changes from baseline
Description
Assessment of spirometry at 3, 6, 9, 12 months of treatment
Time Frame
12 months
Title
exercise capacity changes
Description
Assessment of 6MWD at 3, 6, 9, 12 months of treatment
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 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
Facility Information:
Facility Name
Federal Research Clinical Center FMBA of Russia
City
Moscow
ZIP/Postal Code
115682
Country
Russian Federation

12. IPD Sharing Statement

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

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