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

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ClinicalTrials.gov Identifier: NCT02594839
Recruitment Status : Completed
First Posted : November 3, 2015
Last Update Posted : January 9, 2018
Sponsor:
Information provided by (Responsible Party):
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

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.

Condition or disease Intervention/treatment Phase
Idiopathic Interstitial Pneumonia Interstitial Lung Disease Idiopathic Pulmonary Fibrosis Drug: Bone marrow mesenchymal stem cells Drug: Placebo Phase 1 Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : February 2013
Actual Primary Completion Date : January 2018
Actual Study Completion Date : January 2018


Arm Intervention/treatment
Experimental: MSCs
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
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 Comparator: placebo
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
intravenous infusion of 400 mL saline




Primary Outcome Measures :
  1. Safety: Number of serious adverse events [ Time Frame: 12 months ]
    registration of adverse events related to infusion and 12 months follow-up


Secondary Outcome Measures :
  1. DLCO changes from baseline [ Time Frame: 12 months ]
    Assessment of the diffusing lung capacity at 3, 6, 9, 12 months of treatment

  2. FVC changes from baseline [ Time Frame: 12 months ]
    Assessment of spirometry at 3, 6, 9, 12 months of treatment

  3. exercise capacity changes [ Time Frame: 12 months ]
    Assessment of 6MWD at 3, 6, 9, 12 months of treatment



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02594839


Locations
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Russian Federation
Federal Research Clinical Center FMBA of Russia
Moscow, Russian Federation, 115682
Sponsors and Collaborators
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia

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Responsible Party: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
ClinicalTrials.gov Identifier: NCT02594839     History of Changes
Other Study ID Numbers: ILD-01
First Posted: November 3, 2015    Key Record Dates
Last Update Posted: January 9, 2018
Last Verified: January 2018

Keywords provided by Federal Research Clinical Center of Federal Medical & Biological Agency, Russia:
interstitial lung disease
idiopathic interstitial pneumonia
idiopathic pulmonary fibrosis
stem cells

Additional relevant MeSH terms:
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Fibrosis
Pneumonia
Lung Diseases
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases
Respiratory Tract Infections