Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

Stem Cell Transplant Complications Clinical Trial

Official title:

Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03187431
• Other study ID #: AssiutU4
• Status: Not yet recruiting
• Phase: Phase 1
• First received: April 11, 2017
• Last updated: June 13, 2017
• Start date: December 11, 2017
• Est. completion date: December 1, 2018

Study information

• Verified date: June 2017
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 12
• Est. completion date: December 1, 2018
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Lung Diseases, Interstitial
• Pulmonary Fibrosis
• Stem Cell Transplant Complications

Intervention

Biological:
• autologous bone marrow mesenchymal stem cells
intravenous infusion

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Post therapy diffusing capacity of CO% (DLCO)predicted	Efficacy of procedure	6-12 months
Secondary	post therapy forced vital capacity (FVC)% predicted.	efficacy of the procedure	6-12 months