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IRCT20090128001605N18 IRCT 2020-01-18 Shiraz University of Medical Sciences The effect of mesenchymal stem cells on amniotic membrane The effect of human umbilical cord whartons jelly stem cells cultured on amniotic membrane on chronic wound healing 2018-11-22 anticipated 15 Complete https://irct.ir/trial/1046 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. N/A Chronic wound. Intervention 1: 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. Intervention 2: 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. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is No more information
public Ali Akbar Mohammadi
Training center for burn injuries amiralmomenin, Km 2 Sadra
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3821 9638 mohamadiaa@sums.ac.ir Shiraz University of Medical Sciences scientific Seyedeh-Sara Hashemi
Training center for burn injuries amiralmomenin, Km 2 Sadra
Shiraz Iran (Islamic Republic of) 7198754361 +98 71 3622 3418 sara_hashemi@sums.ac.ir Shiraz University of Medical Sciences Iran (Islamic Republic of) 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 20 years 60 years Both Pregnant Women Any patients that is treated with medicine that causes wound healing disorder, malignancy, or osteomyelitis in the wound L98.4 Chronic ulcer of skin, not elsewhere classified Treatment - Other Treatment - Other 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. 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. 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. 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. Shiraz University of Medical Sciences Approved 2016-03-07 Ethics committee of Shiraz University of Medical Sciences Shiraz University of Medical Sciences, Zand Blvd Shiraz Fars Iran (Islamic Republic of)