Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
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|ClinicalTrials.gov Identifier: NCT02790762|
Recruitment Status : Unknown
Verified May 2016 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was: Not yet recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
|Condition or disease||Intervention/treatment||Phase|
|Pneumoconiosis||Biological: Human umbilical cord mesenchymal stem cells||Phase 1|
Human umbilical cord mesenchymal stem cells exhibit the potential to differentiate into mature cells typical of several tissues, which have been confirmed in in vivo and in vitro experiments.
To investigate the effects of hUC-MSC treatment for Pneumoconiosis, 10 patients with Pneumoconiosis will be enrolled and receive 4 times of hUC-MSC transplantation.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis|
|Study Start Date :||June 2016|
|Estimated Primary Completion Date :||June 2017|
|Estimated Study Completion Date :||October 2017|
Experimental: hUC-MSC treatment
Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Biological: Human umbilical cord mesenchymal stem cells
A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion, and repeated every week for four times.
Other Name: hUC-MSC
- Severity of adverse events [ Time Frame: 12 months ]According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
- Immunological Indicator in serum [ Time Frame: 1, 3 ,6 and 12 months ]Expression levels of various cytokines including interferon-γ、IL-2、IL-1β、IL-4 and transforming growth factor-β1 in serum(U/ml).
- The level of ceruloplasmin in serum [ Time Frame: 1, 3 ,6 and 12 months ]
- The level of type Ⅲ procollagen peptide in serum [ Time Frame: 1, 3 ,6 and 12 months ]
- Lung function as assessed by spirometry [ Time Frame: 1, 3 ,6 and 12 months ]
- Chest high kilovolt X-ray examination [ Time Frame: 12 month ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790762
|Contact: Jin S Cao, lab master||+86 0734-53137955||CaoJS@hornetcon.com|
|The second Affiliated Hospital of University of Soth China||Not yet recruiting|
|Hengyang, Hunan, China, 431224|
|Contact: Guo Q Li, Professor 0734-8899939 ext 355 LiGQ@126.com|
|Principal Investigator:||Guo Q Li, Professor||The second Affiliated Hospital of University of Soth China|