Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

NCT03187431 | Unknown Phase 1

• 1 other identifier: AssiutU4
• Study Type: interventional
• Target: 12
• Locations: 0 countries
• Sites: N/A

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

Keywords

Stem cell; Therapy; IPF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Post therapy diffusing capacity of CO% (DLCO)predicted

  6-12 months

• post therapy forced vital capacity (FVC)% predicted.

  6-12 months

Study Arms (1)

IPF patients

EXPERIMENTAL

autologous bone marrow mesenchymal stem cells

Biological: autologous bone marrow mesenchymal stem cells

Interventions

autologous bone marrow mesenchymal stem cells BIOLOGICAL

intravenous infusion

IPF patients

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology

Study Record Dates

• First Submitted: April 11, 2017
• First Posted: June 15, 2017
• Study Start: December 11, 2017
• Primary Completion: October 1, 2018
• Study Completion: December 1, 2018
• Last Updated: June 15, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will not share