Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

Phase 1

• Conditions: Pneumoconiosis
• Interventions: Biological: Human umbilical cord mesenchymal stem cells

• Registration Number: NCT02790762
• Lead Sponsor: Shenzhen Hornetcorn Bio-technology Company, LTD

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.

Study Timeline

• Status Verified: 2016-05
• Study First Submitted: 2016-05-20
• Study First Submitted QC: 2016-05-31
• Last Update Submitted: 2016-05-31
• Study Start: 2016-06
• Study First Posted: 2016-06-06
• Last Update Posted: 2016-06-06
• Primary Completion: 2017-06
• Study Completion: 2017-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
hUC-MSC treatment	Human umbilical cord mesenchymal stem cells	Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Primary Outcome Measures

Name	Time	Method
Severity of adverse events	12 months	According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)

Secondary Outcome Measures

Name	Time	Method
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	Expression levels of various cytokines including interferon-γ、IL-2、IL-1β、IL-4 and transforming growth factor-β1 in serum(U/ml).

Trial Locations

Locations (1)

The second Affiliated Hospital of University of Soth China; 🇨🇳 Hengyang, Hunan, China