Principal goal of study is to evaluate regeneration of human skin by adipose-derived stem cells (ADSC) cultured on scaffold. Specific goals are ability to extract ADSCs from autologous fat in human and proliferating and differentiating them in vitro in a scaffold covered with a silicon layer to prevent wound infection and evaluate their take after applying on deep burn area regarding clinical and histopathology parameters of wound healing. Design of this study is double blinded in which included 30 patients are assigned with third degree burn less than 30% TBSA who are admitted in a Motahari referral burn center. Patients are randomized into two groups of case and control with 15 patients in each. Exclusion criteria are non-thermal burns >30%BSA and association with inhalation injury, patients below 15 and over 50, Diabetics and other systemic conditions that impairs wound healing, Multiple organ failure and those with clinical and/or par clinical signs and symptoms of wound infection (SIRS). Prepared scaffold with and without ADSCs processed from autologous fat are applied in the burn wounds covered by a silicon sheet by a blinded surgeon. Wounds are biopsied after first, 3rd and 12th weeks and evaluate for clinical and histopathological criteria of wound healing. Outcome analysis would be done by SPSS.
General information
Acronym
ADSC:Adipose cell Derived Stem Cell
IRCT registration information
IRCT registration number:IRCT201202169044N1
Registration date:2012-07-05, 1391/04/15
Registration timing:prospective
Last update:
Update count:0
Registration date
2012-07-05, 1391/04/15
Registrant information
Name
Kamran Asadi
Name of organization / entity
Tehran University of Medical Sciences, Motahari Burn Center
Country
Iran (Islamic Republic of)
Phone
+98 21 8887 6226
Email address
asadi_kamran@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences Vice Chancellor for research & Pasture Institute
Expected recruitment start date
2012-07-22, 1391/05/01
Expected recruitment end date
2013-01-20, 1391/11/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Regeneration of human skin by adipose-derived stem cells (ADSC) cultured on scaffold
Public title
Adipose Cell Derived Stem Cell application in deep burn healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion: third degree deep burn patients with less than 30% TBSA involvement.
Exclusion criteria:
1. Non thermal burns and association with inhalation injury.
2. Patients below 15 y and above 50 y.
3. Diabetics and those with systemic conditions that impairs wound healing.
4. Multiple organ failure (respiratory, renal, etc...).
5. Wound infection.
6. SIRS : Include: fever >38c or hypothermia. >36c ,.Tachycardia >90 ppm, locoytosis WBC>4000 or Locopenia <1200, bandemia >10%.
Number of blood vessels counted by digital camera in milimeter
2
Description
Collagen Number
Timepoint
At the end of third week
Method of measurement
Counting collagen bundles under microscope
3
Description
Collagen maturity
Timepoint
At the end of third week
Method of measurement
Ratio of mature collagen bundles to the whole collagen in the wound garding in low, moderate, high
4
Description
Granulation
Timepoint
at the end of third week
Method of measurement
Fibroplasia and angiogenesis in the wound beed grading in low, moderate and high.
5
Description
Epithelialization
Timepoint
At the end of third week
Method of measurement
Epithelialization density is graded in low , moderate and high
6
Description
Inflamation
Timepoint
At the end of third week
Method of measurement
Inflamatory cells infiltration density garding in low, modarate and high
7
Description
Graft take
Timepoint
1, 3 and 12 week
Method of measurement
Clinical judgment
Secondary outcomes
1
Description
Wound infection
Timepoint
1, 3 and 12 week
Method of measurement
Appearance of wound
Intervention groups
1
Description
Intervention: Prepared scaffold with ADSCs processed from autologous fat are applied in the burn wounds covered by a silicon sheet and would healing would be monitored then after.
Category
Treatment - Surgery
2
Description
Control : Prepared scaffold without ADSCs in control group is applied in the burn wounds and covered by a silicon sheet .
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Motahari Burn Center
Full name of responsible person
Dr. Kamran Asadi
Street address
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences, Vice chancellor for research