Status:
UNKNOWN
Allogenic Stem Cell Therapy in Patients With Acute Burn
Lead Sponsor:
Shenzhen Beike Bio-Technology Co., Ltd.
Collaborating Sponsors:
The Second Affiliated Hospital of Kunming Medical University
Conditions:
Burns
Eligibility:
All Genders
18-65 years
Phase:
PHASE1
PHASE2
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 pro...
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.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2013
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT01443689
Start Date
July 1 2011
End Date
July 1 2013
Last Update
November 28 2012
Active Locations (1)
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1
The Second Affiliated Hospital of Kunmming Medical College
Kunming, Yunnan, China, 650033