MSCsPhase 1MSCsNCT02669199
MSCs Source of Sweat Gland Cells of Large Area Skin Injury Patients Transplant of the Wound
A Phase 1 study testing MSCs in people with MSCs, run by Chinese PLA General Hospital at 1 site in China.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- MSCs
- What is being tested?
- MSCs
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Jan 2012to Dec 2015
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Conditions
- MSCs
- Being tested
- MSCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCsBiological
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
| Study group | Role | What they receive |
|---|---|---|
| MSCs | Experimental | 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 Receives: Biological: MSCs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events
Frequency and severity of Adverse Events
Measured: 12 months
Secondary outcomes (1)
Relative Wound Area Regression of 40% or More at 12 Week
Measured: 12 Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2016 (estimated)
- Study startJan 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MSCsStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xiaobing Fu, Chinese PLA General Hospital
- Investigators
- xiaobing Fu, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02669199
- Sponsor's protocol ID
- CHIN-PLAGH-ST-007
- Acronym
- MSCs
- Status last verified
- Jan 2016
- First submitted
- 21 Jan 2016
- Last updated
- 1 Feb 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02669199
- Acronym / sponsor ID
- MSCs / CHIN-PLAGH-ST-007
- Conditions
- MSCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Jan 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 1 Feb 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MSCs | Experimental | Biological: MSCsThe 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MSCsThe 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 |
Primary outcome
Frequency of Adverse Events
Time frame: 12 months
Frequency and severity of Adverse Events
1 secondary outcome
Relative Wound Area Regression of 40% or More at 12 Week
Time frame: 12 Week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Feb 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xiaobing Fu principal investigator
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MSCs in people with MSCs, run by Chinese PLA General Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frequency of Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Feb 2016; AzTrials last refreshed its copy on 8 Nov 2026.