Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumoconiosis

Intervention / Treatment
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* Biological: Human umbilical cord mesenchymal stem cells


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: hUC-MSC treatment<br>Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up. | Biological: Human umbilical cord mesenchymal stem cells<br>* A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion, and repeated every week for four times.<br>* Other names: hUC-MSC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severity of adverse events | According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE) | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunological Indicator in serum | Expression levels of various cytokines including interferon-γ、IL-2、IL-1β、IL-4 and transforming growth factor-β1 in serum(U/ml). | 1, 3 ,6 and 12 months | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stem cells, Mesenchymal Stem Cells, Umbilical Cord-Mesenchymal Stem Cells, Pneumoconiosis