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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02543073
Date of registration: 04/09/2015
Prospective Registration: No
Primary sponsor: Nanfang Hospital of Southern Medical University
Public title: MSC for Treatment of Interstitial Lung Disease After Allo-HSCT
Scientific title: Mesenchymal Stem Cell for Treatment of Interstitial Lung Disease After Allogenetic Hematopoietic Stem Cell Transplantation
Date of first enrolment: September 2014
Target sample size: 60
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT02543073
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  Phase 1/Phase 2
Countries of recruitment
China
Contacts
Name:     Ren Lin, MD
Address: 
Telephone: +86-020-61641613
Email: lansinglinren@hotmail.com
Affiliation: 
Name:     Ren Lin
Address: 
Telephone:
Email: lansinglinren@hotmail.com
Affiliation: 
Name:     Qifa Liu, MD
Address: 
Telephone:
Email:
Affiliation:  Nanfang Hospital of Southern Medical University
Key inclusion & exclusion criteria

Inclusion Criteria:

- Receiving allo-HSCT

- Diagnosed with ILD after allo-HSCT

Exclusion Criteria:

- Any abnormality in a vital sign (e.g., heart rate, respiratory rate, or blood
pressure)

- Patients with any conditions not suitable for the trial (investigators' decision)



Age minimum: 18 Years
Age maximum: 65 Years
Gender: All
Health Condition(s) or Problem(s) studied
Bronchiolitis Obliterans
Hematopoietic Stem Cell Transplantation
Lung Diseases, Interstitial
Intervention(s)
Biological: MSCs
Drug: Glucocorticoid
Drug: AZM
Primary Outcome(s)
Response rate of ILD [Time Frame: 4 weeks]
Secondary Outcome(s)
Overall Survival [Time Frame: 3 year]
Secondary ID(s)
MSC-ILD-2015
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Sun Yat-sen University
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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