Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis

NCT ID: NCT02790762

Last Updated: 2016-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2017-10-31

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.

Conditions

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Pneumoconiosis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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hUC-MSC treatment

Patients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.

Group Type EXPERIMENTAL

Human umbilical cord mesenchymal stem cells

Intervention Type BIOLOGICAL

A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion, and repeated every week for four times.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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hUC-MSC

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Second Hospital University of South China

OTHER

Sponsor Role collaborator

Shenzhen Hornetcorn Bio-technology Company, LTD

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Guo Q Li, Professor

Role: PRINCIPAL_INVESTIGATOR

The second Affiliated Hospital of University of Soth China

Locations

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The second Affiliated Hospital of University of Soth China

Hengyang, Hunan, China

Site Status

Countries

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China

Central Contacts

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Jin S Cao, lab master

Role: CONTACT

+86 0734-53137955

Facility Contacts

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Guo Q Li, Professor

Role: primary

0734-8899939 ext. 355

Other Identifiers

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HYK-pneumoconiosis

Identifier Type: -

Identifier Source: org_study_id

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