Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

May 31, 2016 updated by: Shenzhen Hornetcorn Bio-technology Company, LTD

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

The purpose of this study is to evaluate the safety and efficacy of human umbilical cord mesenchymal stem cell(hUC-MSC) for Pneumoconiosis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

10

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Hengyang, Hunan, China, 431224
        • The second Affiliated Hospital of University of Soth China
        • Contact:
          • Guo Q Li, Professor
          • Phone Number: 355 0734-8899939
          • Email: LiGQ@126.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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:
  • hUC-MSC

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Severity of adverse events
Time Frame: 12 months
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
Time Frame: 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).
1, 3 ,6 and 12 months
The level of ceruloplasmin in serum
Time Frame: 1, 3 ,6 and 12 months
1, 3 ,6 and 12 months
The level of type Ⅲ procollagen peptide in serum
Time Frame: 1, 3 ,6 and 12 months
1, 3 ,6 and 12 months
Lung function as assessed by spirometry
Time Frame: 1, 3 ,6 and 12 months
1, 3 ,6 and 12 months
Chest high kilovolt X-ray examination
Time Frame: 12 month
12 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Hornetcorn Bio-technology Company, LTD

Collaborators

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 record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2016

Primary Completion (Anticipated)

June 1, 2017

Study Completion (Anticipated)

October 1, 2017

Study Registration Dates

First Submitted

May 20, 2016

First Submitted That Met QC Criteria

May 31, 2016

First Posted (Estimate)

June 6, 2016

Study Record Updates

Last Update Posted (Estimate)

June 6, 2016

Last Update Submitted That Met QC Criteria

May 31, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HYK-pneumoconiosis

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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