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Clinical Trials/NCT02790762
NCT02790762
Unknown
Phase 1

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

Shenzhen Hornetcorn Bio-technology Company, LTD1 site in 1 country10 target enrollmentJune 2016
ConditionsPneumoconiosis

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.

Registry
clinicaltrials.gov
Start Date
June 2016
End Date
October 2017
Last Updated
9 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Shenzhen Hornetcorn Bio-technology Company, LTD
Responsible Party
Sponsor

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)

Study Sites (1)

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