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IRCT20180619040147N5 IRCT 2021-03-29 Iranian academic center for education culture and research Evaluation of efficacy of local injection of mesenchymal stem cells for the treatment of neuropathic diabetic foot ulcer Evaluation of efficacy of local injection of menstrual blood-derived mesenchymal stem cells SinaBioMBcell for the treatment of chronic neuropathic diabetic foot ulcer in a phase III double-blind randomized clinical trial 2021-04-14 anticipated 80 Complete https://irct.ir/trial/54966 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization-In order to randomly assign 80 cases to the treatment group or control group, 10 blocks of 8 cases will be defined using "https://app.studyrandomizer.com". The treatment group and control group will be identified by codes A and B, respectively. In each block, The number of patients in the treatment group is equal to the number of patients in the control group, and The situation of each block is different from the other blocks, Blinding description: This study is conducted as a double-blind clinical trial study. It indicates that the patients are blind to the treatment they are receiving and the specialist in charge of applying the treatment and collecting the data is also blind to the process. 3 Condition 1: Treatment of chronic neuropathic diabetic foot ulcers. Condition 2: Treatment of chronic neuropathic diabetic foot ulcers. Condition 3: Treatment of chronic neuropathic diabetic foot ulcers. Intervention 1: 40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the treatment group, cells will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied, and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under regular supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection. Cell product preparation: 10 healthy, married women of fertility age who have checked in Avicenna Infertility Center for their routine check-ups will be informed by a gynecologist. After informing them of the study and having their consents, on the second day of their menstruation cycle, their menstrual blood is collected by standard menstrual Diva-cups for 8-12 hours. Afterward, the samples will be placed in pre-prepared and coded tubes containing the culture medium and sent to the GMP grade clean room of Avicenna Research Institute. Mesenchymal cells will be separated and stored in the cell bank until the day of injection. Intervention 2: 40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the control group, normal saline will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection. 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 There is no more information.Making decision will be done after recruiting the study by patients enrollment.
public Gholamreza Esmaeil Javid
Enghelab St, South Flestein St, Nazari St, building No.17
Tehran Iran (Islamic Republic of) 1417613181 +98 21 6698 9110 djavid@ut.ac.ir Iranian academic center for education culture and research scientific Somaieh Kazemnejad
Avicenna Research Institute, Shahid Beheshti University, Shahid Chamran Highway, Tehran, Iran
Tehran Iran (Islamic Republic of) 1936773493 +98 21 2243 2020 kazemnejad_s@yahoo.com Iranian academic center for education culture and research Iran (Islamic Republic of) Chronic diabetic ulcers (more than 6 weeks) grade I-II Wagner classification without osteomyelitis Full thickness ulcer The size of the wound has to be between1-8 cm2 Controlled blood sugar (HbA1c less than 10) Patient's consent and clarification on whether they may be concluded in control or treatment group Non responsive ulcers to previous medications and treatments 30 years 70 years Both Ulcers that are classified as grade 3-4 of Wagner classification or osteomyelitis has occurred Patients that don't meet the age criteria of the study High blood sugar levels The wounds that do not include full layers of skin. The wounds healed by other standard diabetic ulcers treatment methods E11.622 E10.621 E11-40 Type 2 diabetes mellitus with foot ulcer Type 1 diabetes mellitus with foot ulcer Type 2 diabetes mellitus with diabetic neuropathy, unspecified Treatment - Other Treatment - Other 40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the treatment group, cells will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied, and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under regular supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection. Cell product preparation: 10 healthy, married women of fertility age who have checked in Avicenna Infertility Center for their routine check-ups will be informed by a gynecologist. After informing them of the study and having their consents, on the second day of their menstruation cycle, their menstrual blood is collected by standard menstrual Diva-cups for 8-12 hours. Afterward, the samples will be placed in pre-prepared and coded tubes containing the culture medium and sent to the GMP grade clean room of Avicenna Research Institute. Mesenchymal cells will be separated and stored in the cell bank until the day of injection. 40 volunteer patients who refer to the Wound and Tissue Repair Research Center of the University of Medical Sciences, Academic Center for Education, Culture, and Research, will be examined by a dermatologist. After meeting the criteria, they will be divided into treatment and control groups. All of the patients will receive the same standard treatment, debridement of necrotic and infected tissues, controlling the infection, and foam and Alginate bandages for reduction of the pressure. For the control group, normal saline will be injected only once during the whole study into 5 spots (one into the middle and 4 into the margins). The bandages will then be applied and the patients or their caretakers will be informed and educated on how to change the bandages by themselves. They will be under supervision for 48 hours and again evaluated on the first, second, fourth, sixth, and fifth week and again on third, fourth, fifth, and sixth-month post-injection Full thickness closure progress. Timepoint: Before treatment, the first, second, fourth, fifth, and sixth weeks and again on third, fourth, fifth, and sixth-months post-treatment. Method of measurement: On each evaluation period, the wounds will be measured with special devices like a ruler specialized for wound measurements. Evaluation of local side effects (irritation, inflammation, pain, granulation, infection). Timepoint: Before treatment, the first 48 hours, and again from the first week till week six of the study. Method of measurement: Clinical observation. Evaluation of systematic side effects (skin sensitivity, fever, shivering, nausea, vomiting). Timepoint: Before treatment, the first 48 hours, and again from the first week till week six of the study. Method of measurement: Clinical observation. The rate of wound healing. Timepoint: Before treatment, then from first week till week six and then every month till six months post treatment. Method of measurement: Clinical observation. Duration of complete wound healing. Timepoint: From week one, till week six, and then every month till six months post-treatment. Method of measurement: Clinical observation. Side effects of choronic diabetic wounds on patients ( the need of antibiotics prescription and Hospitalization). Timepoint: From week one, till week six, and then every month till six months post-treatment. Method of measurement: Clinical observation. Iranian academic center for education culture and research Approved 2021-03-10 Academic Center for Education, Culture and Research (ACECR)- Biomedical Research Ethics Committee 1270, Secretariat of the Ethics Committee of ACECR,Deputy Director of Research and Technology, Headquarters of ACECR, Opposite the main door of Tehran University, Enghelab Street, Tehran Tehran Tehran Iran (Islamic Republic of)