The purpose of this study was to use the Whartons Jelly mesenchymal stem cells on amniotic membrane to help repair it for the treatment of chronic skin ulcers.
Design
The clinical trial with a community-based control and parallel groups that are assigned by random numbers. Each group consists of 5 patients.
Settings and conduct
All patients will subjected weekly to standard wound treatment consisted of disinfection, debridement when needed, and application of advanced wound dressing and bandages.
The wounds will covered by acellular amniotic membrane seeded with WJSCs for 9 days, every 3 days with a follow up of one month. The percentage and time of wound healing, and the size of wound injury will recorded for each patient. A picture will taken from each lesion at the onset of the study (T0), and after 3, 6, and 9 days post-treatment (T3, T6, T9). The wound size at T0 will determined and the wound closure rate was obtained by dividing the ulcer size at T0 by the number of days needed for healing (cm2/day).
Participants/Inclusion and exclusion criteria
Inclusion criteria: Age between 20-60 years old; Chronic wound less than 1% of the body surface due to vascular causes (arterial, venous and lymphatic), diabetic, radiotherapy, subcutaneous wound
Exclusion criteria: Pregnant Women ; Any patients that is treated with medications causes wound healing, malignancy, or osteomyelitis in the wound
Intervention groups
Intervention group: The amniotic membrane with mesenchymal stem cells will be used
Control group: Amniotic curves will be used alone.
Main outcome variables
Wound surface
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20090128001605N18
Registration date:2020-01-18, 1398/10/28
Registration timing:retrospective
Last update:2020-01-18, 1398/10/28
Update count:0
Registration date
2020-01-18, 1398/10/28
Registrant information
Name
Ali Akbar Mohammadi
Name of organization / entity
Shiraz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 71 1621 6097
Email address
mohamadiaa@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-11-22, 1397/09/01
Expected recruitment end date
2019-02-20, 1397/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of human umbilical cord whartons jelly stem cells cultured on amniotic membrane on chronic wound healing
Public title
The effect of mesenchymal stem cells on amniotic membrane
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 20-60 years old
Chronic wound less than 1% of the body surface due to vascular causes (arterial, venous and lymphatic), diabetic, radiotherapy, subcutaneous wound
Exclusion criteria:
Pregnant Women
Any patients that is treated with medicine that causes wound healing disorder, malignancy, or osteomyelitis in the wound
Age
From 20 years old to 60 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Randomized
Randomization description
Individuals are assigned to each of the groups using a random number table with simple randomization method. Random numbers are generated by computers that randomly adjust the digits, then the researcher give each member of the community a special code or number, then consider the even number for one group, and odd number for other group.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
۱۴۳۳۶- ۷۱۳۴۸
Approval date
2016-03-07, 1394/12/17
Ethics committee reference number
IR.SUMS.REC.1394.51
Health conditions studied
1
Description of health condition studied
Chronic wound
ICD-10 code
L98.4
ICD-10 code description
Chronic ulcer of skin, not elsewhere classified
Primary outcomes
1
Description
Wound surface
Timepoint
The wounds will covered by acellular amniotic membrane seeded with WJSCs for 9 days, every 3 days with a follow up of one month.
Method of measurement
Pellany Metric Software
Secondary outcomes
1
Description
The duration of wound healing
Timepoint
The wounds will cover by acellular amniotic membrane seeded with WJSCs for 9 days, every 3 days with a follow up of one month.
Method of measurement
Days
Intervention groups
1
Description
intervention group: In this group, patients wound will be closed with an amniotic membrane with mesenchymal stem cells and covered for 9 days, every 3 days with a follow up of one month. The percentage and time of wound healing and the size of wound injury will be recorded for each patient. A picture will take from each lesion at the onset of the study (T0), and after 3, 6, and 9 days’ post-treatment (T3, T6, T9). The wound size at T0 will be determined and the wound closure rate was obtained by dividing the ulcer size at T0 by the number of days needed for healing (cm2/day). The dressing method used in this study by the use of mesenchymal stem cells of umbilical cord from the selected cesarean section at 36th and 37th weeks of gestation. The tissues will be transferred to the lab at 4 ° C as soon as surgery is performed in aseptic conditions in a sterile saline phosphate buffer containing 50 μg / ml streptomycin and 50 μg / ml penicillin 50 μg / ml., Then the amniotic membrane is separated by mechanical method from the chorion of placenta and is washed several times with a cold saline phosphate buffer of 4 ºC. Wharton jelly beans are removed gently and transferred to a PBS container. Wharton jelly fragments are fragmented with scalps. The components in the T25 flask containing DMEM, 5% human serum (HS) and antibiotic (penicillin/streptomycin) (1%) will be transferred to the incubator at 37 ° C, humidity 95% and 5% CO2, and after 3 days, of the flask medium will be replaced. After filling the flask floor, the cells will pass through the trypsin 0.25%, after the second passage, 15-20 million cells are transferred to the scapula of the new amniotic fluid (epithelial surface) as a scaffold and It will be used to cover the patients' wound with chronic ulcers.
Category
Treatment - Other
2
Description
Control group: The patients wound will be closed with cell-free amnion and covered for 9 days, every 3 days with a follow up of one month. The percentage and time of wound healing, and the size of wound injury will be recorded for each patient. A picture will take from each lesion at the onset of the study (T0), and after 3, 6, and 9 days’ post-treatment (T3, T6, T9). The wound size at T0 will determined and the wound closure rate was obtained by dividing the ulcer size at T0 by the number of days needed for healing (cm2/day).All patients will be subjected weekly to standard wound treatment consisted of disinfection, debridement when needed, and application of advanced wound dressing and bandages.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Ghadir Mother and Child Hospital
Full name of responsible person
Ali Akbar Mohammadi
Street address
New Quran Blvd, in Golshan Town
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3614 6100
Email
burns1@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Younes Ghasemi
Street address
Vice-chanceller of Research Shiraz University of Medical Sciences; Central department of Shiraz University of Medical Sciences, Zand Blvd
City
Shiraz
Province
Fars
Postal code
71348-14336
Phone
+98 71 3230 5410
Email
ghasemiy@sums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
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
Shiraz University of Medical Sciences
Full name of responsible person
Ali Akbar Mohammadi
Position
Associate Professor, General Surgeon
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Training center for burn injuries amiralmomenin, Km 2 Sadra
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3821 9638
Fax
Email
mohamadiaa@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Seyedeh-Sara Hashemi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Histology
Street address
Training center for burn injuries amiralmomenin, Km 2 Sadra
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3622 3418
Fax
Email
sara_hashemi@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Masoomeh Kherad
Position
Manager of Shiraz Burn Reaserch Center/Bachelor of Nursing
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Training center for burn injuries amiralmomenin, Km 2 Sadra
City
Shiraz
Province
Fars
Postal code
7198754361
Phone
+98 71 3820 8880
Fax
Email
burnres1@sums.ac.ir
Web page address
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