Clinical Trial: Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

Brief Summary: The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.

Detailed Summary:

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.


Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

Current Primary Outcome: Severity of adverse events [ Time Frame: 12 months ]

According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome: Same as current

Information By: Shenzhen Hornetcorn Bio-technology Company, LTD

Dates:
Date Received: May 20, 2016
Date Started: June 2016
Date Completion: October 2017
Last Updated: May 31, 2016
Last Verified: May 2016