A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Pneumoconiosis
- Sponsor
- Shenzhen Hornetcorn Bio-technology Company, LTD
- Enrollment
- 10
- Locations
- 1
- Primary Endpoint
- Severity of adverse events
- Last Updated
- 9 years ago
Overview
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 Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •The patient who have signed the informed consent document;
- •Clinical and radiological evidence of liver cirrhosis.
Exclusion Criteria
- •Pregnant women or lactating mothers;
- •History of neurological disease, head injury or psychiatric disorder;
- •Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
- •With malignant tumors;
- •Abnormal blood coagulation, combine other tumor or special condition;
- •Patients who had participated in other clinical trials within three months prior to this study.
Outcomes
Primary Outcomes
Severity of adverse events
Time Frame: 12 months
According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)
Secondary Outcomes
- Lung function as assessed by spirometry(1, 3 ,6 and 12 months)
- The level of type Ⅲ procollagen peptide in serum(1, 3 ,6 and 12 months)
- The level of ceruloplasmin in serum(1, 3 ,6 and 12 months)
- Chest high kilovolt X-ray examination(12 month)
- Immunological Indicator in serum(1, 3 ,6 and 12 months)