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IRCT20191007045008N2 IRCT 2023-07-26 Tehran University of Medical Sciences stem cells for diabetic chronic wounds healing Investigating the effect of a scaffold containing human placenta-derived mesenchymal stem cells in diabetic chronic wounds healing (phase II) 2023-09-06 anticipated 30 Complete https://irct.ir/trial/70658 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study will use a randomized, double-blind design to investigate the effect of AAM and PLMSCs on wound healing in diabetic patients. Participants will be randomly assigned to one of three groups: AAM group, PLMSCs + AAM group, or control group. The AAM group will receive a scaffold containing an acellular amniotic membrane, the PLMSCs + AAM group will receive a scaffold containing both placenta-derived mesenchymal stem cells and acellular amniotic membrane, and the control group will receive a placebo scaffold without any active ingredients. Randomization will be performed using a computer-generated randomization list that will be created by an independent statistician. The randomization list will be stratified by age, gender, and wound size to ensure a balance between the three groups. The study investigators, participants, and outcome assessors will be blinded to treatment allocation, Blinding description: To maintain blinding, all study scaffolds will be identical in appearance and packaging. The study investigators will not know which scaffold each participant receives. The outcome assessors will also be blinded to treatment allocation and will not know which group each participant belongs to when assessing wound healing outcomes. In addition, participants will be instructed not to reveal their treatment allocation to the outcome assessors during follow-up visits. Any unblinding events will be recorded and reported in the study findings. 2 diabetes mellitus. Intervention 1: Intervention group 1: AAM (Acellular amniotic membrane) Amniotic membrane preparation: The acellular amniotic membrane were used to providing the three-dimensional scaffold for seeding MSCs. After obtaining informed consent placenta was donated from healthy mother after caesarean delivery. placenta rinsed in sterile (PBS) and then human amniotic membrane(HAM) was separated from the chorion with forceps and washed three times with PBScontaining Penicillin-Streptomycin (10,000 U/mL)( gibco, usa) and cut into 3 cm×3 cm pieces, which were placed in dishes with the amniotic epithelial layer face up. Then pieces of HAM were decellularized with 0.5 M NaOH according to previous study(Saghizadeh, Winkler et al. 2013). all the procedures were carried out under aseptic conditions. haematoxylin and eosin (H&E) staining of the samples were accomplished to confirme Aecellularization process. Samples were viewed by light microscopy after staining with H&E. On the desired day for transplantation, membranes and tissue engineering products are transported to the hospital by Cool Box, and in this group, the acellularized amnion membrane is placed on the wound site. After 6 weeks, the final result will be seen. Of course, during this period, the healing process of the wound will be checked once a week. Intervention 2: Intervention group 2: AAM+PLMSCs (acellular human amniotic membrane graft+placenta-derived MSCs). Mesenchymal stem cells are counted and suspended in fresh culture media. In each piece, 3 ml of cell suspension is planted and incubated at 37°C, 5% CO2 and 95% humidity. After 24 hours, the culture medium is changed. On the fifth day, the prepared tissue engineered grafts will be ready for transplantation. The grafts are packed in sterile bottles and transported to the clinic for transplantation. Grafts are transplanted to the wound site for 6 weeks, this transplant will be done once a week, and after 6 weeks the results will be evaluated. Patients will be followed up weekly for the first month and then monthly for 6 months. Intervention 3: Control group: Ctrl (will receive a normal dressing). 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 -
public Babak Arjmand
No 111, 19th St., North Kargar Ave., Tehran 14114, Iran, 1457965597, Tel +98 218 835 4367
tehran Iran (Islamic Republic of) 1457965597 +98 21 8835 4367 barjmand@sina.tums.ac.ir Tehran University of Medical Sciences scientific Babak Arjmand
No 111, 19th St., North Kargar Ave., Tehran 14114, Iran, 1457965597, Tel +98 218 835 4367
tehran Iran (Islamic Republic of) 1457965597 +98 21 8835 4367 barjmand@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Sign Informed consent form Diagnosed with diabetes mellitus no pregnancy grade 1 or 2 wounds Men or women, 18 years old and above 18 years 45 years Both uncontrolled disease history pregnancy cancerous or pre-cancerous lesions in the treated area E08 Diabetes mellitus due to underlying condition Treatment - Devices Treatment - Devices Treatment - Devices Intervention group 1: AAM (Acellular amniotic membrane) Amniotic membrane preparation: The acellular amniotic membrane were used to providing the three-dimensional scaffold for seeding MSCs. After obtaining informed consent placenta was donated from healthy mother after caesarean delivery. placenta rinsed in sterile (PBS) and then human amniotic membrane(HAM) was separated from the chorion with forceps and washed three times with PBScontaining Penicillin-Streptomycin (10,000 U/mL)( gibco, usa) and cut into 3 cm×3 cm pieces, which were placed in dishes with the amniotic epithelial layer face up. Then pieces of HAM were decellularized with 0.5 M NaOH according to previous study(Saghizadeh, Winkler et al. 2013). all the procedures were carried out under aseptic conditions. haematoxylin and eosin (H&E) staining of the samples were accomplished to confirme Aecellularization process. Samples were viewed by light microscopy after staining with H&E. On the desired day for transplantation, membranes and tissue engineering products are transported to the hospital by Cool Box, and in this group, the acellularized amnion membrane is placed on the wound site. After 6 weeks, the final result will be seen. Of course, during this period, the healing process of the wound will be checked once a week. Intervention group 2: AAM+PLMSCs (acellular human amniotic membrane graft+placenta-derived MSCs). Mesenchymal stem cells are counted and suspended in fresh culture media. In each piece, 3 ml of cell suspension is planted and incubated at 37°C, 5% CO2 and 95% humidity. After 24 hours, the culture medium is changed. On the fifth day, the prepared tissue engineered grafts will be ready for transplantation. The grafts are packed in sterile bottles and transported to the clinic for transplantation. Grafts are transplanted to the wound site for 6 weeks, this transplant will be done once a week, and after 6 weeks the results will be evaluated. Patients will be followed up weekly for the first month and then monthly for 6 months. Control group: Ctrl (will receive a normal dressing) Percentage of wound closure. Timepoint: several weeks to several months. Method of measurement: It will be measured using digital photography and software analysis. Time to complete wound closure. Timepoint: vary from weeks to months. Method of measurement: digital photography and software analysis. Pain reduction. Timepoint: several weeks. Method of measurement: visual analog scale. Quality of life improvement. Timepoint: several months to several years. Method of measurement: validated questionnaire. Tehran University of Medical Sciences Approved 2023-04-15 Tehran University of Medical Sciences Endocrine & Metabolism Research Institute Ethics Committee No.111,19th st., North Kargar Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)