Allogenic Stem Cell Therapy in Patients With Acute Burn
NCT ID: NCT01443689
Last Updated: 2012-11-28
Study Results
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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UNKNOWN
PHASE1/PHASE2
20 participants
INTERVENTIONAL
2011-07-31
2013-07-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group1 :Conventional plus hUCMSCs treatment
Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus hUCMSCs transplantation.
Group 2: Conventional plus hCBMNCs and hUCMSCs therapy
Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
Group 3:Conventional therapy
Participants will be given conventional therapy only with a 6 months follow-up.
Conventional therapy
Participants will be given conventional therapy only.
Interventions
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human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus hUCMSCs transplantation.
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
Conventional therapy
Participants will be given conventional therapy only.
Eligibility Criteria
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Inclusion Criteria
* Diagnosed with Acute, Moderate-Severe, full-thickness burn:
Burn occurring within the 72 hours prior to administration. TBSA 20-55%, third degree wounds surface area \< 19 % ;
* Willing to sign the Informed Consent Form.
Exclusion Criteria
* Chronically malnourished, poor medical condition or shock
* Systemic inflammatory response syndrome (SIRS) or septicopyemia
* Moderate-severe inhalation injury airways to lung
* HIV+
* Autoimmune disease, e.g. lupus erythematosus, multiple sclerosis.
* Severe pulmonary and hematological disease, malignancy or hypo-immunity.
* Currently undertaking other treatment that may affect the safety/efficacy of stem cells.
* Pregnancy or lactation
* Enrollment in other trials in the last 3 months.
* Other criteria the investigator consider improper for inclusion.
18 Years
65 Years
ALL
No
Sponsors
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The Second Affiliated Hospital of Kunming Medical University
OTHER
Shenzhen Beike Bio-Technology Co., Ltd.
INDUSTRY
Responsible Party
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Locations
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The Second Affiliated Hospital of Kunmming Medical College
Kunming, Yunnan, China
Countries
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Central Contacts
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Facility Contacts
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Jinfeng Fu
Role: primary
Other Identifiers
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BKCR-BURN-1.0(2011)
Identifier Type: -
Identifier Source: org_study_id