Design and evaluation of biological dressing efficiency with tissue engineering structure in wound healing of Epidermolysis bullosa patients: the first stage of phase 2
Design and evaluation of biological dressing efficiency with tissue engineering approach in wound healing of Epidermolysis bullosa patients: a pilot study
Design
Clinical trial with intervention group, community-based and pragmatic, with parallel, non-blind, non-random
Predicted sample size: 15; phase 2
Settings and conduct
This study will be performed in Imam Reza Hospital.
For the first intervention group, adipose tissue stem cells will be placed on the amniotic scaffold and placed on the wounds created on the skin area.
Also, for the second intervention group, keratinocytes will be placed on the scaffold and the healing effect of the wound will be investigated.
Participants/Inclusion and exclusion criteria
Entry requirements:
Agreeing to participate in the study; Lack of access to common dressings
No entry:
Underlying disease; The unwillingness of the patient; Infection
Intervention groups
1- Use of biological dressing of amniotic membrane as scaffold and keratinocyte cells
2- Using amniotic membrane dressing as a scaffold and adipose stem cells
Main outcome variables
Recovery time; The size of wound healing; Wound recurrence; Wound recovery time
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181222042074N2
Registration date:2022-06-29, 1401/04/08
Registration timing:prospective
Last update:2022-06-29, 1401/04/08
Update count:0
Registration date
2022-06-29, 1401/04/08
Registrant information
Name
Shirin Toosi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 51 1843 2825
Email address
tusi1063@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-07-21, 1401/04/30
Expected recruitment end date
2023-01-20, 1401/10/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Design and evaluation of biological dressing efficiency with tissue engineering structure in wound healing of Epidermolysis bullosa patients: the first stage of phase 2
Public title
Evaluation of the effect of amniotic scaffold and keratinocyte cells on wound healing from butterfly wing disease
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
People with a diagnosis of butterfly wing genetic disease
Agreeing with informed consent to participate in the study
Exclusion criteria:
Reluctance to cooperate
Complications in wounds such as infections
Age
To 10 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Other
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Mashhad University of Medical Sciences
Street address
University St., Mashhad University of Medical Sciences (Qureshi) Office Building, Second Floor, Mashhad Vice Chancellor for Research
City
Mashhad
Province
Razavi Khorasan
Postal code
9183773193
Approval date
2022-06-11, 1401/03/21
Ethics committee reference number
IR.MUMS.REC.1401.043
Health conditions studied
1
Description of health condition studied
Epidermolysis bullosa
ICD-10 code
Q81
ICD-10 code description
Epidermolysis bullosa
Primary outcomes
1
Description
Wound healing rate
Timepoint
weekly
Method of measurement
Clinical examinations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group 1: Amniotic scaffold with adipose stem cells. Isolated samples are used for liposuction to extract MSCs. Tissue tissue is treated with type 2 collagenase enzyme and the working sample is incubated with type 2 collagenase enzyme in a 37◦c shaker hot water bath for 1 hour. The container containing the 37◦c water bath is transferred under the hood. To neutralize the effect of type 2 collagenase enzyme by adding serum-containing medium (FBS 10%) and transferring the mixture to 50 ml Falcons (the tissue is seen to be changed in a 1: 3 ratio with 10% FBS culture medium and then digested into falcons. 50 ml is transferred). The suspended cells, tissue and culture medium and DPBS in the 3 supernatants in the falcons are then removed using a 25 ml pipette and the Falcons containing the cell suspension are placed in a 400G centrifuge for 6 minutes to precipitate the cell. Take. they take. The next step was to discard the supernatant and dissolve the resulting cell sediment in MSC medium and pour the cells into T75 flasks and finally transfer the flasks to the incubator (one T75 flask was used for every 15 ml of primary fat sample). The obtained cells, after completely covering the surface of the flask, obtain a cell plate and then implant it on a scaffold made of amniotic membrane.
Category
Treatment - Devices
2
Description
Intervention group 2: Amniotic scaffold with keratinocyte cells. In this study of keratinocytes, skin samples from the abdomen or hypogastric area after liposuction surgery or neonatal circumcision samples will be used. The received skin sample is transferred under the hood and the efficient part of the skin will be cut to 10 cm x 5 cm. It will then be rinsed 3 times in PBS solution (containing 2X Penicillin / Streptomycin) and then the skin pieces will be transferred into 7 ml of Dispase solution (10 mg / ml) containing 1X Penicillin / Streptomycin and the samples will be stored at 4 ° C. The temperature will be 17-18 hours. The sample is then trypsinized for 15 minutes and then the culture medium is pipetted with 10% FBS and the cells are separated using a 70 micron mesh filter and a 400 rpm centrifuge for 6 minutes. The complete culture medium is then transferred to the flask on the cell plate and the culture medium is changed every two days. After the cells have completely filled the surface of the flask, a cell plate is taken and the cells are implanted in the amniotic scaffold.
Category
Treatment - Devices
3
Description
Control group 1: Amniotic scaffold. Amniotic dressing will be purchased ready-made from manufacturers and the effectiveness of this cell-free scaffold in wound healing will be evaluated. Also, this type of dressing is now used to repair many cracks.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam reza hospital
Full name of responsible person
Ahmad Shah Farhat
Street address
Imam Reza Square, Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
9183773193
Phone
+98 51 3854 3031
Email
toosis@mums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Dr. Majid Ghayour Mobarhan
Street address
University St., Mashhad University of Medical Sciences (Qureshi) Office Building, Second Floor, Mashhad Vice Chancellor for Research
City
Mashhad
Province
Razavi Khorasan
Postal code
9183773193
Phone
+98 51 3841 1538
Email
GhayourM@mums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mashhad University of Medical Sciences
Proportion provided by this source
66
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shirin Toosi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Bu Ali Square, Health Science and Technology Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9188617871
Phone
0517034785
Email
Toosis@mums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Ahmad Shah Farhat
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Pediatrics
Street address
Imam Reza Hospital
City
Mashhad
Province
Razavi Khorasan
Postal code
0000000000
Phone
+98 51 3854 3031
Email
FarhatA@mums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mashhad University of Medical Sciences
Full name of responsible person
Shirin Toosi
Position
Researcher
Latest degree
Ph.D.
Other areas of specialty/work
Tissue Engineering
Street address
Bu Ali Square, Health Science and Technology Park
City
Mashhad
Province
Razavi Khorasan
Postal code
9183773194
Phone
+98 51 3703 4785
Email
Toosis@mums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available