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Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis

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ClinicalTrials.gov Identifier: NCT03187431
Recruitment Status : Not yet recruiting
First Posted : June 15, 2017
Last Update Posted : June 15, 2017
Sponsor:
Information provided by (Responsible Party):
Aliae AR Mohamed Hussein, 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

Condition or disease Intervention/treatment Phase
Stem Cell Transplant Complications Biological: autologous bone marrow mesenchymal stem cells Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
Estimated Study Start Date : December 11, 2017
Estimated Primary Completion Date : October 1, 2018
Estimated Study Completion Date : December 1, 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: IPF patients
autologous bone marrow mesenchymal stem cells
Biological: autologous bone marrow mesenchymal stem cells
intravenous infusion




Primary Outcome Measures :
  1. number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation [ Time Frame: 6 months ]
    safety and side effects


Secondary Outcome Measures :
  1. Post therapy diffusing capacity of CO% (DLCO)predicted [ Time Frame: 6-12 months ]
    Efficacy of procedure

  2. post therapy forced vital capacity (FVC)% predicted. [ Time Frame: 6-12 months ]
    efficacy of the procedure



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

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Responsible Party: Aliae AR Mohamed Hussein, Prof. Dr. Aliae AR Mohamed-Hussein, Professor of Pulmonology, Assiut University
ClinicalTrials.gov Identifier: NCT03187431     History of Changes
Other Study ID Numbers: AssiutU4
First Posted: June 15, 2017    Key Record Dates
Last Update Posted: June 15, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Aliae AR Mohamed Hussein, Assiut University:
Stem cell
Therapy
IPF

Additional relevant MeSH terms:
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Pulmonary Fibrosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases