Overview

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

Status:
Completed
Trial end date:
2018-01-01
Target enrollment:
0
Participant gender:
All
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.
Phase:
Phase 1/Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
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