Clinical trial NCT01443689: 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
Overall status: UNKNOWN
Phase: PHASE1
PHASE2
Conditions: Burns
Keywords: Extensive Burn
Human Cord Blood Mononuclear Cells
Human Umbilical Cord Mesenchymal Stem Cells
Lead sponsor: Shenzhen Beike Bio-Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: The Second Affiliated Hospital of Kunming Medical University
First posted: 2011-09-30
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: The ratio of wound contraction and re-epithelialisation
timeFrame: 6 months after treatment
measure: Complete healing time for investigated burn area
timeFrame: 6 months after treatment
measure: Vancouver Scar Scale
timeFrame: 6 months after treatment
Secondary outcomes:
measure: Incidence of infections and bleedings in burn wounds
timeFrame: 6 months after treatment]
measure: Engraftment assessment: Vitality of the graft
timeFrame: 6 months after treatment]
measure: McGill pain Questionnaire
timeFrame: 6 months after treatment
measure: Incidence of Adverse Events and Serious Adverse Events
timeFrame: 6 months after treatment
Other outcomes:
Locations:
city: Kunming
country: China
facility: The Second Affiliated Hospital of Kunmming Medical College
state: Yunnan
Study officials:
References: