Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

Assiut University

Status and phase

Unknown

Phase 1

Conditions

Stem Cell Transplant Complications

Treatments

Biological: autologous bone marrow mesenchymal stem cells

Study type

Interventional

Funder types

Other

Identifiers

NCT03187431

AssiutU4

Details and patient eligibility

About

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

Enrollment

12 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

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