Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

Phase 1

• Conditions: Stem Cell Transplant Complications
• Interventions: Biological: autologous bone marrow mesenchymal stem cells

• Registration Number: NCT03187431
• Lead Sponsor: Assiut University

Brief Summary

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

Detailed Description

Not available

Basic Information
|
Recruitment & Eligibility
|
Study & Design

Study Timeline

• Study First Submitted: 2017-04-11
• Status Verified: 2017-06
• Study First Submitted QC: 2017-06-13
• Last Update Submitted: 2017-06-13
• Study First Posted: 2017-06-15
• Last Update Posted: 2017-06-15
• Study Start: 2017-12-11
• Primary Completion: 2018-10-01
• Study Completion: 2018-12-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 12

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
IPF patients	autologous bone marrow mesenchymal stem cells	autologous bone marrow mesenchymal stem cells

Primary Outcome Measures

Name	Time	Method
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation	6 months	safety and side effects

Secondary Outcome Measures

Name	Time	Method
Post therapy diffusing capacity of CO% (DLCO)predicted	6-12 months	Efficacy of procedure
post therapy forced vital capacity (FVC)% predicted.	6-12 months	efficacy of the procedure