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Allogenic Stem Cell Therapy in Patients With Acute Burn

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2012 by Shenzhen Beike Bio-Technology Co., Ltd..
Recruitment status was:  Recruiting
Sponsor:
Collaborator:
The Second Affiliated Hospital of Kunming Medical University
Information provided by (Responsible Party):
Shenzhen Beike Bio-Technology Co., Ltd.
ClinicalTrials.gov Identifier:
NCT01443689
First received: September 27, 2011
Last updated: November 26, 2012
Last verified: November 2012
September 27, 2011
November 26, 2012
July 2011
March 2013   (Final data collection date for primary outcome measure)
  • The ratio of wound contraction and re-epithelialisation [ Time Frame: 6 months after treatment ]
  • Complete healing time for investigated burn area [ Time Frame: 6 months after treatment ]
  • Vancouver Scar Scale [ Time Frame: 6 months after treatment ]
Same as current
Complete list of historical versions of study NCT01443689 on ClinicalTrials.gov Archive Site
  • Incidence of infections and bleedings in burn wounds [ Time Frame: 6 months after treatment] ]
  • Engraftment assessment: Vitality of the graft [ Time Frame: 6 months after treatment] ]
  • McGill pain Questionnaire [ Time Frame: 6 months after treatment ]
  • Incidence of Adverse Events and Serious Adverse Events [ Time Frame: 6 months after treatment ]
Same as current
Not Provided
Not Provided
 
Allogenic Stem Cell Therapy in Patients With Acute Burn
A Phase Ι/Π Study of Human Cord Blood Mononuclear Cells and Human Umbilical Cord Mesenchymal Stem Cells Transplantation in Patients With Acute Burn
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.
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.
Interventional
Phase 1
Phase 2
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Burns
  • Biological: human umbilical cord mesenchymal stem cells
    Participants will be given conventional therapy plus hUCMSCs transplantation.
  • Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
    Participants will be given conventional therapy plus and hCBMNCs and hUCMSCs transplantation.
  • Drug: Conventional therapy
    Participants will be given conventional therapy only.
  • Experimental: Group1 :Conventional plus hUCMSCs treatment
    Participants will be given conventional therapy plus human cord mesenchymal stem cells transplantation with a 6 months follow-up.
    Intervention: Biological: human umbilical cord mesenchymal stem cells
  • Experimental: 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.
    Intervention: Biological: human cord blood mononuclear cells and human umbilical cord mesenchymal stem cells
  • Active Comparator: Group 3:Conventional therapy
    Participants will be given conventional therapy only with a 6 months follow-up.
    Intervention: Drug: Conventional therapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
20
July 2013
March 2013   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
18 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
China
 
 
NCT01443689
BKCR-BURN-1.0(2011)
Yes
Not Provided
Not Provided
Shenzhen Beike Bio-Technology Co., Ltd.
Shenzhen Beike Bio-Technology Co., Ltd.
The Second Affiliated Hospital of Kunming Medical University
Not Provided
Shenzhen Beike Bio-Technology Co., Ltd.
November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP