Pneumoconiosis
Conditions
Keywords
stem cells, Mesenchymal Stem Cells, Umbilical Cord-Mesenchymal Stem Cells, 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 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.
Interventions
BIOLOGICALHuman 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.
Sponsors
The Second Hospital University of South China
Shenzhen Hornetcorn Bio-technology Company, LTD
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Severity of adverse events | 12 months | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
China
Contacts
Primary ContactJin S Cao, lab master
Outcome results
None listed