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MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound (MSCs)

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ClinicalTrials.gov Identifier: NCT02669199
Recruitment Status : Completed
First Posted : February 1, 2016
Last Update Posted : February 1, 2016
Sponsor:
Information provided by (Responsible Party):
Xiaobing Fu, Chinese PLA General Hospital

Brief Summary:
The main purpose of this test is to assess the umbilical cord mesenchymal stem cells (MSCs) UC between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects

Condition or disease Intervention/treatment Phase
MSCs Biological: MSCs Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Between Umbilical Cord Mesenchymal Stem Cells Sources Sweat Gland Samples of Large Area Skin Wound Injury Patients Before and After the Transplant Center, Open, Random, Own More Controlled Clinical Trials
Study Start Date : January 2012
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

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Arm Intervention/treatment
Experimental: MSCs
The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects
Biological: MSCs
The main purpose of this test is to assess the umbilical cord MSCs between source sample sweat gland cells wound transplanted effectiveness and safety for the treatment of large area skin lesions of the subjects




Primary Outcome Measures :
  1. Frequency of Adverse Events [ Time Frame: 12 months ]
    Frequency and severity of Adverse Events


Secondary Outcome Measures :
  1. Relative Wound Area Regression of 40% or More at 12 Week [ Time Frame: 12 Week ]


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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Sign the informed consent form when the age of 18 and 60 years old or less or more men or women (not pregnancy) The burned area: 10-20% TBSA, can satisfy the self control Time: early for skin grafts For location: limbs, chest and back

Exclusion Criteria:

  • Serious allergic constitution; Have influence on the speed of wound healing of chronic disease patients; According to the researcher's judgment, may endanger the safety of the subjects or scheme compliance of any chronic disease or severe disease, including cancer, severe heart disease, kidney disease, liver disease, respiratory disease, nerve diseases of the nervous system, blood system diseases, etc.; Clinical researchers or for other reasons can't cooperate with the doctors, and other information is not suitable for clinical study of patients.

Can not meet the requirement of the long-term follow-up of patients.


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): NCT02669199


Locations
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China, Beijing
Chinese PLA General Hospital
Beijing, Beijing, China, 100039
Sponsors and Collaborators
Chinese PLA General Hospital
Investigators
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Principal Investigator: xiaobing Fu Chinese PLA General Hospital

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Responsible Party: Xiaobing Fu, PI, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT02669199     History of Changes
Other Study ID Numbers: CHIN-PLAGH-ST-007
First Posted: February 1, 2016    Key Record Dates
Last Update Posted: February 1, 2016
Last Verified: January 2016