The purpose of this study is to generate skin grafts containing their own intrinsic micro vascular plexus as a nutritional support for both, the dermal and the epidermal compartment by using the autologous SVF. The starting cell population was derived from the SVF (cells from the SVF can spontaneously develop a microvasculature) isolated from human adipose tissue, co-seeded with human keratinocyte and fibroblast cells and cultured on fibrin-collagen hydrogel scaffold. For this experiment we planned to study 10 patients assigned with diabetic wounds of less than 2mm2 who are admitted in a Skin and stem cell research center. The Patients are randomized into two groups of case and control with 5 patients in each group. The Prepared hydrogel scaffold with and without cells processed from autologous fat and skin are applied to the diabetic wounds. The Wounds will become biopsied after fourth, 7th and 14th days and are evaluated for clinical and histopathological criteria of wound healing.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015110224834N1
Registration date:2015-11-29, 1394/09/08
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-29, 1394/09/08
Registrant information
Name
Mahsa Mollapour Sisakht
Name of organization / entity
Skin and Stemcell Research Center
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
m.mollapour@kaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Skin and Stem Cell Research Center, Tehran University of Medical Sciences, Dr. Parvin Mansouri.Vice Chancellor for research of Kashan University of Medical Sciences, Dr.Gholamali Hamidi.
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-22, 1395/08/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation the effect of Stromal Vascular Fraction to induce vascular network formation in diabetic wounds
Public title
Mesenchymal stem Cell application in diabetic wound healing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criterion:diabetic patients with less than 2 square millimeters wounds involvement.
Exclusion criteria:(Actively) infected ulcer; Immune deficient patients; Patients with a known failed ipsilateral revascularization procedure within 4 weeks prior to enrollment; Patients receiving systemic or injection of antiangiogenic drugs; Patients with poorly controlled diabetes mellitus.
Number of gap junction and pinocytotic vesicles of counted by transmission electron microscopy analyses
2
Description
Sebometer
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
3
Description
PHmeter
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
4
Description
Pigmentation
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
5
Description
Colorimeter
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
6
Description
Skin Hydration
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
7
Description
Cutometer
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Biometry
8
Description
Wound size
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Count the squares (in centimeters) after placing the acetate sheet over a wound,measurements the size of the wound using a ruler
9
Description
Graft take
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Clinical judgment
10
Description
Vascularization in In Vivo
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Clinical judgment
11
Description
Percentage of mature endothelial cells
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Flowcytometry
Secondary outcomes
1
Description
Wound infection
Timepoint
Fourth, 7th and 14th days after transplantation
Method of measurement
Appearance of wound
Intervention groups
1
Description
Intervention: Prepared scaffold with keratinocyte, fibroblast and SVF cells processed from autologous fat and skin, respectively, are applied in the diabetic wounds and would healing would be monitored then after.
Category
Treatment - Surgery
2
Description
Control: Prepared scaffold without cells in control group is applied in the diabetic wounds.
Category
Treatment - Surgery
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin and Stem Cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Street address
No. 4, Maryam deadend, South Kamranyeh, Tehran, Iran.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Kashan University of Medical Sciences,
Full name of responsible person
Dr. Gholamali Hamidi
Street address
Kashan University of Medical Sciences,Qotb Ravandi Blvd, Kashan, Iran
City
Kashan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Kashan University of Medical Sciences,
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
2
Sponsor
Name of organization / entity
Vice Chancellor for research of Skin and Stem Cell Research Center,
Full name of responsible person
Dr.Parvin Mansouri
Street address
No. 4, Maryam deadend, South Kamranyeh, Tehran, Iran.
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Skin and Stem Cell Research Center,
Proportion provided by this source
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Skin and Stemcell Research center, Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour
Position
PH.d candidate
Other areas of specialty/work
Street address
No. 4, Maryam deadend, South Kamranyeh, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 222201710
Fax
Email
m.mollapour@kaums.ac.ir; mahsamollapur@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Skin and Stemcell Research Center
Full name of responsible person
Dr. Mohamadali Nilforoushzadeh
Position
Associate Professor
Other areas of specialty/work
Street address
No. 4, Maryam deadend, South Kamranyeh, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
Email
Dr_nilforoush@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Skin and Stem cell Research Center, Tehran University of Medical Sciences
Full name of responsible person
Mahsa Mollapour
Position
PhD Candidate
Other areas of specialty/work
Street address
No. 4, Maryam deadend, South Kamranyeh, Tehran, Iran.
City
Tehran
Postal code
Phone
+98 21 2220 1710
Fax
+98 21 2223 9264
Email
m.mollapour@kaums.ac.ir; mahsamollapur@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)