Back to resultsAllogenic Stem Cell Therapy in Patients With Acute Burn
Primary Purpose
Burns
Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
human umbilical cord mesenchymal stem cells
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Conventional therapy
Sponsored by
About this trial
This is an interventional treatment trial for Burns focused on measuring Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells
Eligibility Criteria
Inclusion Criteria:
- Between age 18- 65 years, both gender.
- 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:
- All other burns except thermal origin.
- 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.
Sites / Locations
- The Second Affiliated Hospital of Kunmming Medical CollegeRecruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Group1 :Conventional plus hUCMSCs treatment
Group 2: Conventional plus hCBMNCs and hUCMSCs therapy
Group 3:Conventional therapy
Arm Description
Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.
Participants will be given conventional therapy only with a 6 months follow-up.
Outcomes
Primary Outcome Measures
The ratio of wound contraction and re-epithelialisation
Complete healing time for investigated burn area
Vancouver Scar Scale
Secondary Outcome Measures
Incidence of infections and bleedings in burn wounds
Engraftment assessment: Vitality of the graft
McGill pain Questionnaire
Incidence of Adverse Events and Serious Adverse Events
Full Information
NCT ID
NCT01443689
First Posted
September 27, 2011
Last Updated
November 26, 2012
Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
The Second Affiliated Hospital of Kunming Medical University
1. Study Identification
Unique Protocol Identification Number
NCT01443689
Brief Title
Allogenic Stem Cell Therapy in Patients With Acute Burn
Official Title
A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn
Study Type
Interventional
2. Study Status
Record Verification Date
November 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
March 2013 (Anticipated)
Study Completion Date
July 2013 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborators
The Second Affiliated Hospital of Kunming Medical University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Burn trauma,especially extensive ones, remains a life-threatening local and general inflammatory condition destroying the skin and underlying tissues, and resulting in serious sequelae. Remarkable progress has been achieved during last 30 years，stem cell therapy plays an important role in this progress. Human umbilical cord mesenchymal stem cells (hUCMSCs) and human cord blood mononuclear cells (hCBMNCs) have been shown to have the ability to modulate the immune response and enhance angiogenesis, suggesting the novel and promising therapeutic strategy for burn. In this study, the safety and efficacy of hUCMSCs and hCBMNCs transplantation will be evaluated in patients with acute burn.
Detailed Description
To investigate the safety and efficacy of human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells transplantation in patients of Acute, Moderate-Severe, Full-thickness burn.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Burns
Keywords
Extensive Burn, Human Cord Blood Mononuclear Cells, Human Umbilical Cord Mesenchymal Stem Cells
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Group1 :Conventional plus hUCMSCs treatment
Arm Type
Experimental
Arm Description
Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
Arm Title
Group 2: Conventional plus hCBMNCs and hUCMSCs therapy
Arm Type
Experimental
Arm Description
Participants will be given conventional therapy plus combination of hCBMNCs together with hUCMSCs transplantation with a 6 months follow-up.
Arm Title
Group 3:Conventional therapy
Arm Type
Active Comparator
Arm Description
Participants will be given conventional therapy only with a 6 months follow-up.
Intervention Type
Biological
Intervention Name(s)
human umbilical cord mesenchymal stem cells
Intervention Description
Participants will be given conventional therapy plus hUCMSCs transplantation.
Intervention Type
Biological
Intervention Name(s)
human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
Intervention Description
Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
Intervention Type
Drug
Intervention Name(s)
Conventional therapy
Intervention Description
Participants will be given conventional therapy only.
Primary Outcome Measure Information:
Title
The ratio of wound contraction and re-epithelialisation
Time Frame
6 months after treatment
Title
Complete healing time for investigated burn area
Time Frame
6 months after treatment
Title
Vancouver Scar Scale
Time Frame
6 months after treatment
Secondary Outcome Measure Information:
Title
Incidence of infections and bleedings in burn wounds
Time Frame
6 months after treatment]
Title
Engraftment assessment: Vitality of the graft
Time Frame
6 months after treatment]
Title
McGill pain Questionnaire
Time Frame
6 months after treatment
Title
Incidence of Adverse Events and Serious Adverse Events
Time Frame
6 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Between age 18- 65 years, both gender.
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:
All other burns except thermal origin.
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jinfeng Fu
Phone
86-871-5351281
Email
ynfjf@hotmail.com
Facility Information:
Facility Name
The Second Affiliated Hospital of Kunmming Medical College
City
Kunming
State/Province
Yunnan
ZIP/Postal Code
650033
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jinfeng Fu
Phone
86-871-5351281
Email
ynfjf@hotmail.com
First Name & Middle Initial & Last Name & Degree
Jinfeng Fu
12. IPD Sharing Statement
Learn more about this trial
Allogenic Stem Cell Therapy in Patients With Acute Burn
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