Back to resultsRole of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
Primary Purpose
Stem Cell Transplant Complications
Status
Unknown status
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
autologous bone marrow mesenchymal stem cells
Sponsored by
About this trial
This is an interventional treatment trial for Stem Cell Transplant Complications focused on measuring Stem cell, Therapy, IPF
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.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
IPF patients
Arm Description
autologous bone marrow mesenchymal stem cells
Outcomes
Primary Outcome Measures
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
safety and side effects
Secondary Outcome Measures
Post therapy diffusing capacity of CO% (DLCO)predicted
Efficacy of procedure
post therapy forced vital capacity (FVC)% predicted.
efficacy of the procedure
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03187431
Brief Title
Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
Official Title
Mesenchymal Stem Cell as Therapeutic Modality in Interstitial Pulmonary Fibrosis
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
December 11, 2017 (Anticipated)
Primary Completion Date
October 1, 2018 (Anticipated)
Study Completion Date
December 1, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stem Cell Transplant Complications
Keywords
Stem cell, Therapy, IPF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
IPF patients
Arm Type
Experimental
Arm Description
autologous bone marrow mesenchymal stem cells
Intervention Type
Biological
Intervention Name(s)
autologous bone marrow mesenchymal stem cells
Intervention Description
intravenous infusion
Primary Outcome Measure Information:
Title
number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation
Description
safety and side effects
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Post therapy diffusing capacity of CO% (DLCO)predicted
Description
Efficacy of procedure
Time Frame
6-12 months
Title
post therapy forced vital capacity (FVC)% predicted.
Description
efficacy of the procedure
Time Frame
6-12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Role of Stem Cell Therapy in Interstitial Pulmonary Fibrosis
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