Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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 Names:
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Outcome Measures
Primary Outcome Measures
- Severity of adverse events [12 months]
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
Secondary Outcome Measures
- Immunological Indicator in serum [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 [1, 3 ,6 and 12 months]
- The level of type Ⅲ procollagen peptide in serum [1, 3 ,6 and 12 months]
- Lung function as assessed by spirometry [1, 3 ,6 and 12 months]
- Chest high kilovolt X-ray examination [12 month]
Eligibility Criteria
Criteria
Inclusion Criteria:
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The patient who have signed the informed consent document;
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Clinical and radiological evidence of liver cirrhosis.
Exclusion Criteria:
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Pregnant women or lactating mothers;
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History of neurological disease, head injury or psychiatric disorder;
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Patients with positive human immunodeficiency (HIV) at screening indicative of current of pass infection;
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With malignant tumors;
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Abnormal blood coagulation, combine other tumor or special condition;
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Patients who had participated in other clinical trials within three months prior to this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The second Affiliated Hospital of University of Soth China | Hengyang | Hunan | China | 431224 |
Sponsors and Collaborators
- Shenzhen Hornetcorn Bio-technology Company, LTD
- The Second Affiliated Hospital of University of South China
Investigators
- Principal Investigator: Guo Q Li, Professor, The second Affiliated Hospital of University of Soth China
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- HYK-pneumoconiosis