Safety and clinical effectiveness of autologous mesenchymal stromal cell infusion as adjuncttreatment in patients with Idiopathic Pulmonary Fibrosis
- Conditions
- J84.1Other interstitial pulmonary diseases with fibrosis
- Registration Number
- DRKS00008790
- Lead Sponsor
- The Republican Research and Practical Centre for Pulmonology and TB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 40
Patients 21 through 75 years of age with diagnose of IPF based on diagnostic criteria of An Official ATS/ERS/JRS/ALAT Statement: Idiopathic Pulmonary Fibrosis: Evidence-based Guidelines for Diagnosis and Management”. The duration of the disease should be more than three months, bilateral predominantly basilar inspiratory crackles should be present. In addition, the following functional abnormalities should be present: dyspnea, vital capacity of no more than 80 percent of the predicted value, single-breath carbon monoxide diffusing capacity (DLCO) less than 80 percent of the predicted value.
Any one of the criteria below makes the patient non-eligible for enrolment into the study:
1.HIV positivity
2.Hepatitis B or C positivity
3. Tuberculosis
4.Autoimmune or systemic diseases
5.Pregnancy
6.liver, renal or other organ/system failure(s)
7.Sepsis
8.Cancer
9.Younger than 21 years and older than 75 years
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary end points are the following: the adverse events, the changes in vital capacity and DLCO between baseline and month 6, 12.
- Secondary Outcome Measures
Name Time Method Chest X-ray and CT scan at baseline, 6 and 12 months, and mortality during 12 months