Stem Cell Transplant Complications
Conditions
Keywords
Stem cell, Therapy, IPF
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
Interventions
intravenous infusion
Sponsors
Assiut University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| number of participants with treatment related side effects as infection, allergic reaction, disease acute exacerbation, and ectopic tissue formation | 6 months | safety and side effects |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Post therapy diffusing capacity of CO% (DLCO)predicted | 6-12 months | Efficacy of procedure |
| post therapy forced vital capacity (FVC)% predicted. | 6-12 months | efficacy of the procedure |
Outcome results
None listed