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IRCT20190517043609N1 IRCT 2020-01-25 Kerman University of Medical Sciences Evaluation of the effect of intracavernous stem cell injection on the treatment of erectile dysfunction in diabetic patients Clinical trial of the evaluation of the effect of intracavernous stem cell injection on the treatment of erectile dysfunction compared to control group in diabetic patients 2019-09-22 anticipated 20 Complete https://irct.ir/trial/40988 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the block randomization method is used. Thus, of the 4 blocks, each block consisting of 2 intervention groups and 2 control groups, with the aim of progressing smoothly over the time of the groups, and this method continued until the sample size was completed 20 (including 10 Intervention group and 10 control group or 5 blocks of 4), Blinding description: In this study, the primary researcher (physician and data collector) is aware of the type of injectable material, but patients are unaware of the type of injectable material and are kept blind. Patients were divided into two groups of 10 intervention and control groups who were injected randomized with stem cell or normal saline. 3 Erectile dysfunction. Intervention 1: Intervention group: In the intervention group with local anesthesia, a tissue sample of about half a centimeter diameter without any need for suture was taken from each patient's oral mucosa and inserted into a solution of phosphate buffer containing antibiotics and amphotripsin (Exir Nano Sina co.) and immediately sent to the University's Stem Cell Center. Mucosal tissue transmitted 3 times with antibiotic buffered phosphate buffer and amphotripsin, divided into small parts under sterile conditions and at 4 ° C for 24 hours, adjacent to DMEM (Dulbeccos Modified Eagle Medium) (Neda Shimi Co.) medium containing 4 mg / mL of dysphasic enzyme and 3 mg / mL collagenase type 1 is placed. After 24 hours, the enzymum is slowly released and placed in a DMEM medium containing 15% FBS and 1% antibiotic (penicillin / streptomycin) (Exir Nano Sina co.) in a CO2 incubator (5%) with a humidity of 95% and a temperature of 37 °.After sticking and growing cells, which lasts for at least about 10 days, the adherent cells of the adipose trypsin enzyme are cultured again in the T25 flask after separation. Finally, the cells were examined for stem cell markers and purity by fluocytometric method and if th purity was more than 95%, the cells collected to be injected into the patient should be kept in the physician. After taking the required amount of stem cells (60-50 million), the sample is sent to the Freeze room to the urological room and after melting with normal saline 0.9% diluted (up to 2 cc), into the intervention group in each corpus cavernosome is injected 1 cc. Then all patients in the intervention group follow by the International Index of Erectile Function (IIEF5) questionnaire and Doppler Sonography, Fasting Blood Sugar (FBS), and Glycated Hemoglobin (HBA1C) within three months and six months after injection. In addition, morning erection is recorded by patients every day. Intervention 2: Control group: In control group, 1 cc normal saline is injected in each Corpus cavernosum .Then all patients in the control group follow by the IIEF5 questionnaire and Doppler Sonography, FBS, and HBA1C within three months and six months after injection. In addition, morning erection is recorded by patients every day. 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 Mahbobe Mirzaie
St. Qarani Hospital Bahonar
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3222 1600 mirzaeimahboubeh@yahoo.com Kerman University of Medical Sciences scientific Mahbobe Mirzaie
St. Qarani Hospital Bahonar
Kerman Iran (Islamic Republic of) 7613747181 +98 34 3222 1600 mirzaeimahboubeh@yahoo.com Kerman University of Medical Sciences Iran (Islamic Republic of) Erectal dysfunction Diabetes Ages: 55-75 years 55 years 75 years Male Hypertension Hyperlipidemia Obesity Low testosterone High prolactin Hypothyroidism Hyperthyroidism Impaired Luteinizing Hormone ( LH) Impaired Follicle Stimulating Hormone ( FSH) N52 Male erectile dysfunction Treatment - Drugs Treatment - Drugs Intervention group: In the intervention group with local anesthesia, a tissue sample of about half a centimeter diameter without any need for suture was taken from each patient's oral mucosa and inserted into a solution of phosphate buffer containing antibiotics and amphotripsin (Exir Nano Sina co.) and immediately sent to the University's Stem Cell Center. Mucosal tissue transmitted 3 times with antibiotic buffered phosphate buffer and amphotripsin, divided into small parts under sterile conditions and at 4 ° C for 24 hours, adjacent to DMEM (Dulbeccos Modified Eagle Medium) (Neda Shimi Co.) medium containing 4 mg / mL of dysphasic enzyme and 3 mg / mL collagenase type 1 is placed. After 24 hours, the enzymum is slowly released and placed in a DMEM medium containing 15% FBS and 1% antibiotic (penicillin / streptomycin) (Exir Nano Sina co.) in a CO2 incubator (5%) with a humidity of 95% and a temperature of 37 °.After sticking and growing cells, which lasts for at least about 10 days, the adherent cells of the adipose trypsin enzyme are cultured again in the T25 flask after separation. Finally, the cells were examined for stem cell markers and purity by fluocytometric method and if th purity was more than 95%, the cells collected to be injected into the patient should be kept in the physician. After taking the required amount of stem cells (60-50 million), the sample is sent to the Freeze room to the urological room and after melting with normal saline 0.9% diluted (up to 2 cc), into the intervention group in each corpus cavernosome is injected 1 cc. Then all patients in the intervention group follow by the International Index of Erectile Function (IIEF5) questionnaire and Doppler Sonography, Fasting Blood Sugar (FBS), and Glycated Hemoglobin (HBA1C) within three months and six months after injection. In addition, morning erection is recorded by patients every day. Control group: In control group, 1 cc normal saline is injected in each Corpus cavernosum .Then all patients in the control group follow by the IIEF5 questionnaire and Doppler Sonography, FBS, and HBA1C within three months and six months after injection. In addition, morning erection is recorded by patients every day. Erectile function. Timepoint: 3 and 6 months after the injection. Method of measurement: Questionnaire IIEF5 (International Index of Erectile Dysfunction Inventory) and Patient Statement and Color Doppler Sonography. . Timepoint: . Method of measurement: . Kerman University of Medical Sciences Approved 2019-10-13 Ethics Committee of Kerman University of Medical Sciences Havaniroz Street ,Ghadir Street Kerman Kerman Iran (Islamic Republic of)