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Clinical Trials/DRKS00008790
DRKS00008790
Not yet recruiting
Phase 1

Safety and clinical effectiveness of autologous mesenchymal stromal cell infusion as adjuncttreatment in patients with Idiopathic Pulmonary Fibrosis

The Republican Research and Practical Centre for Pulmonology and TB0 sites40 target enrollmentJuly 13, 2015
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ConditionsJ84.1Other interstitial pulmonary diseases with fibrosis

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
J84.1
Sponsor
The Republican Research and Practical Centre for Pulmonology and TB
Enrollment
40
Status
Not yet recruiting
Last Updated
last year
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 13, 2015
End Date
TBD
Last Updated
last year
Study Type
Interventional
Sex
All

Investigators

Sponsor
The Republican Research and Practical Centre for Pulmonology and TB

Eligibility Criteria

Inclusion Criteria

  • •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.

Exclusion Criteria

  • •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)
  • •9\.Younger than 21 years and older than 75 years

Outcomes

Primary Outcomes

Not specified

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