Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
A Phase I Study of Human Umbilical Cord-Mesenchymal Stem Cells for Pneumoconiosis
1 other identifier
interventional
10
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 20, 2016
CompletedStudy Start
First participant enrolled
June 1, 2016
CompletedFirst Posted
Study publicly available on registry
June 6, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2017
CompletedJune 6, 2016
May 1, 2016
1 year
May 20, 2016
May 31, 2016
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Severity of adverse events
According to National Cancer Institute Common Terminology Criteria for Adverse Events（NCI-CTCAE)
12 months
Secondary Outcomes (5)
Immunological Indicator in serum
1, 3 ,6 and 12 months
The level of ceruloplasmin in serum
1, 3 ,6 and 12 months
The level of type Ⅲ procollagen peptide in serum
1, 3 ,6 and 12 months
Lung function as assessed by spirometry
1, 3 ,6 and 12 months
Chest high kilovolt X-ray examination
12 month
Study Arms (1)
hUC-MSC treatment
EXPERIMENTALPatients will receive human umbilical cord mesenchymal stem cells transplantation with a 12 months follow-up.
Interventions
A single dose of 2×107 hUC-MSC will be implanted to patients by intravenous infusion, and repeated every week for four times.
Eligibility Criteria
You may qualify if:
- The patient who have signed the informed consent document;
- Clinical and radiological evidence of liver cirrhosis.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
The second Affiliated Hospital of University of Soth China
Hengyang, Hunan, 431224, China
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Guo Q Li, Professor
The second Affiliated Hospital of University of Soth China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 20, 2016
First Posted
June 6, 2016
Study Start
June 1, 2016
Primary Completion
June 1, 2017
Study Completion
October 1, 2017
Last Updated
June 6, 2016
Record last verified: 2016-05