Back to resultsUmbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
Primary Purpose
Sweat Gland Diseases
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
UCB Mesenchymal Stem Cells treatment
Sponsored by
About this trial
This is an interventional treatment trial for Sweat Gland Diseases
Eligibility Criteria
Inclusion Criteria:
- Burn area:10-20％TBSA
Exclusion Criteria:
- Have influence on the speed of wound healing of patients with chronic diseases
Sites / Locations
- Chinese PLA General HospitalRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
UCB Mesenchymal Stem Cells
Arm Description
UCB Mesenchymal Stem Cells treatment of patients with skin injury
Outcomes
Primary Outcome Measures
Frequency of Adverse Events
Frequency and severity of Adverse Events
Secondary Outcome Measures
Active and inactive lesion count
Full Information
NCT ID
NCT02304562
First Posted
November 21, 2014
Last Updated
December 1, 2014
Sponsor
Chinese PLA General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02304562
Brief Title
Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
Official Title
Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
Study Type
Interventional
2. Study Status
Record Verification Date
November 2014
Overall Recruitment Status
Unknown status
Study Start Date
January 2013 (undefined)
Primary Completion Date
December 2017 (Anticipated)
Study Completion Date
December 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese PLA General Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Patients with skin injury treated with Umbilical Cord Blood-derived Mesenchymal Stem Cells,such as deep burn damaged sweat glands,Effectiveness of Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair is determined.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sweat Gland Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
UCB Mesenchymal Stem Cells
Arm Type
Experimental
Arm Description
UCB Mesenchymal Stem Cells treatment of patients with skin injury
Intervention Type
Biological
Intervention Name(s)
UCB Mesenchymal Stem Cells treatment
Intervention Description
reduce skin injury
Primary Outcome Measure Information:
Title
Frequency of Adverse Events
Description
Frequency and severity of Adverse Events
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Active and inactive lesion count
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Burn area:10-20％TBSA
Exclusion Criteria:
Have influence on the speed of wound healing of patients with chronic diseases
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
xiaobing FU
Phone
+86(10)937516
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
xiaobing FU
Organizational Affiliation
Chinese PLA General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Chinese PLA General Hospital
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100039
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
haojie Hao
Phone
+86(10)937516
First Name & Middle Initial & Last Name & Degree
haojie Hao
Phone
+86(10)937516
Email
haojieh@163.com
12. IPD Sharing Statement
Citations:
PubMed Identifier
17056067
Citation
Fu X, Qu Z, Sheng Z. Potentiality of mesenchymal stem cells in regeneration of sweat glands. J Surg Res. 2006 Dec;136(2):204-8. doi: 10.1016/j.jss.2005.03.024. Epub 2006 Oct 20.
Results Reference
background
Learn more about this trial
Umbilical Cord Blood-derived Mesenchymal Stem Cells in Regeneration of Sweat Glands and Body Repair
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