Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

NCT ID: NCT03187431

Last Updated: 2017-06-15

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 12 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-12-11
• Study Completion Date: 2018-12-01

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

Conditions

Stem Cell Transplant Complications

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

IPF patients

autologous bone marrow mesenchymal stem cells

Group Type: EXPERIMENTAL

autologous bone marrow mesenchymal stem cells

Intervention Type: BIOLOGICAL

intravenous infusion

Interventions

autologous bone marrow mesenchymal stem cells

intravenous infusion

Intervention Type: BIOLOGICAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Aliae AR Mohamed Hussein

Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Other Identifiers

AssiutU4

Identifier Type: -

Identifier Source: org_study_id