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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02594839
• Date of registration: 01/11/2015
• Prospective Registration: No
• Primary sponsor: Federal Research Clinical Center of Federal Medical & Biological Agency, Russia
• Public title: Safety and Efficacy of Allogeneic Mesenchymal Stem Cells in Patients With Rapidly Progressive Interstitial Lung Disease
• Scientific 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
• Date of first enrolment: February 2013
• Target sample size: 20
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02594839
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 1/Phase 2

Countries of recruitment

Russian Federation

Key inclusion & exclusion 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 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



Age minimum: 20 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Idiopathic Interstitial Pneumonia

Interstitial Lung Disease

Idiopathic Pulmonary Fibrosis

Intervention(s)

Drug: Placebo

Drug: Bone marrow mesenchymal stem cells

Primary Outcome(s)

Safety: Number of serious adverse events [Time Frame: 12 months]

Secondary Outcome(s)

FVC changes from baseline [Time Frame: 12 months]

DLCO changes from baseline [Time Frame: 12 months]

exercise capacity changes [Time Frame: 12 months]

Secondary ID(s)

ILD-01

Source(s) of Monetary Support

Please refer to primary and secondary sponsors