Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02790762
Recruitment Status : Unknown
Verified May 2016 by Shenzhen Hornetcorn Bio-technology Company, LTD.
Recruitment status was:  Not yet recruiting
First Posted : June 6, 2016
Last Update Posted : June 6, 2016
Sponsor:
Collaborator:
The Second Affiliated Hospital of University of South China
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Pneumoconiosis Biological: Human umbilical cord mesenchymal stem cells Phase 1

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
Study Start Date : June 2016
Estimated Primary Completion Date : June 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine


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 Name: hUC-MSC




Primary Outcome Measures :
  1. Severity of adverse events [ Time Frame: 12 months ]
    According to National Cancer Institute Common Terminology Criteria for Adverse Events(NCI-CTCAE)


Secondary Outcome Measures :
  1. 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).

  2. The level of ceruloplasmin in serum [ Time Frame: 1, 3 ,6 and 12 months ]
  3. The level of type Ⅲ procollagen peptide in serum [ Time Frame: 1, 3 ,6 and 12 months ]
  4. Lung function as assessed by spirometry [ Time Frame: 1, 3 ,6 and 12 months ]
  5. Chest high kilovolt X-ray examination [ Time Frame: 12 month ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02790762


Contacts
Layout table for location contacts
Contact: Jin S Cao, lab master +86 0734-53137955 CaoJS@hornetcon.com

Locations
Layout table for location information
China, Hunan
The second Affiliated Hospital of University of Soth China Not yet recruiting
Hengyang, Hunan, China, 431224
Contact: Guo Q Li, Professor    0734-8899939 ext 355    LiGQ@126.com   
Sponsors and Collaborators
Shenzhen Hornetcorn Bio-technology Company, LTD
The Second Affiliated Hospital of University of South China
Investigators
Layout table for investigator information
Principal Investigator: Guo Q Li, Professor The second Affiliated Hospital of University of Soth China

Layout table for additonal information
Responsible Party: Shenzhen Hornetcorn Bio-technology Company, LTD
ClinicalTrials.gov Identifier: NCT02790762     History of Changes
Other Study ID Numbers: HYK-pneumoconiosis
First Posted: June 6, 2016    Key Record Dates
Last Update Posted: June 6, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Shenzhen Hornetcorn Bio-technology Company, LTD:
stem cells
Mesenchymal Stem Cells
Umbilical Cord-Mesenchymal Stem Cells
Pneumoconiosis

Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumoconiosis
Lung Diseases, Interstitial
Lung Diseases
Respiratory Tract Diseases
Lung Injury
Occupational Diseases