Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

Study Overview
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Brief Summary
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Currently, the application status of MSCs as treatment modalities in IPF is still in its infancy and remains exploratory. Although a number of safety and efficacy clinical trials of MSCs as therapeutic options in immune-mediated and cardiac diseases have already been published with tantalizing results, to our disappointment, pulmonary and critical care medicine have traditionally lagged behind other therapeutic and research fields including hematology, gastroenterology and cardiology in translational studies of the use of reparative cells

Official Title
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Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis

Conditions
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Stem Cell Transplant Complications

Intervention / Treatment
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* Biological: autologous bone marrow mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 18 to 75 years (both inclusive) high-resolution computed tomography (HRCT) scan that is very suggestive or consistent with a probable diagnosis of usual interstitial pneumonia. Bronchoalveolar lavage must be performed at any time before inclusion and must have failed to show features supporting alternative diagnoses. The duration of the disease should be more than three months, and bibasilar inspiratory crackles should be present. dyspnea score of at least 2 on a scale of 0 (minimum) to 10 (maximum). FVC > 50% of the predicted normal value and DLco > 35% of the predicted value. Patients under treatment with n-acetylcysteine or pirfenidone should discontinue drug and enter a wash-out period for at least 6 weeks prior study enrolment. Exclusion Criteria: FVC < 50% predicted normal value and DLCO < 35%predicted normal value. lung cancer or with an evidence of active malignancyfor at least 5 years. uncontrolled heart failure. renal failure hepatic failure, neurological abnormalities including stroke and myasthenia Gravis Anti-coagulants therapy. Active infections.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IPF patients<br>autologous bone marrow mesenchymal stem cells | Biological: autologous bone marrow mesenchymal stem cells<br>* intravenous infusion<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation | safety and side effects | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post therapy diffusing capacity of CO% (DLCO)predicted | Efficacy of procedure | 6-12 months | 
| post therapy forced vital capacity (FVC)% predicted. | efficacy of the procedure | 6-12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Stem cell, Therapy, IPF