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IRCT20080901001159N20 IRCT 2018-05-04 Tehran University of Medical Sciences Effects of cell therapy in treatment of epidermolysis bullosa Evaluation of the efficacy and safety of amniotic membrane seeded by allogenic skin cells on chronic wound of patients with dystrophic epidermolysis bullosa; phase II randomized clinical trial 2018-04-21 anticipated 20 Complete https://irct.ir/trial/29915 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization method: Simple Randomization unit: Individual stratified randomization is not included Randomization Tool: Random number box Allocation concealment: The cell product and placebo are delivered to the physician with code numbers. Then the dressings will be placed on the patient's wound based on randomization number box, Blinding description: In this study, patients, researchers, health care persons including its physician and nurse, and the outcome evaluator are blinded until the end of study. 2 Epidermolysis bullosa. Intervention 1: Intervention group: Amniotic membrane seeded by allogenic fibroblast. Intervention 2: Control group: amniotic membrane. Yes - There is a plan to make this available What will be shared: All data will be shared after unidentifiable of the patients When: 6 months after paper publication To whom: Academic researchers Conditions: In term of analysis the data related to study outcomes Where to obtain: bajouri_md@yahoo.com How to obtain: The request will be assessed by research committee of Skin and Stem cells research center which will be taken around 1-2 months Comments:
public Amir Bajouri
No 9, Shaghayegh alley, Banihashem st, Resalat Ave
Tehran Iran (Islamic Republic of) 16635148 +98 21 2356 2173 bajouri_md@yahoo.com Iranian academic center for education culture and research scientific Mohammad Ali Nilforoushzadeh
Skin and Stem Cell Research Center, third floor, no 4, Maryam impasse, Kamranieh st, Tehran
Tehran Iran (Islamic Republic of) 1937957511 +98 21 2221 2537 sdlrc@mui.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Patients with 2-20 years old Both sexes Dystrophic type of EB Multiple skin wounds which are recurrent during 6 months ago 2 years 20 years Both Pregnancy or lactating Arterial or venous defects in recipient site Immune defficiency Hemolytic anemia Chronic malnutrition Respiratory system defects Diabetes Local infection of recipient site Cell transplantation of recipient site during last 1 year HBV, HCV, and HIV infection Any malignancy of recipient site Q81 Epidermolysis bullosa Treatment - Other Treatment - Other Intervention group: Amniotic membrane seeded by allogenic fibroblast Control group: amniotic membrane Wound extent (cm2). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: Image J software. Safety. Timepoint: intervention start date up to 6 months. Method of measurement: Medical history and physical examination. Tehran University of Medical Sciences Approved 2018-01-01 Ethics committee of Tehran University of Medical Sciences Keshavarz st, Qods st, Central building of university, 6th floor, deputy for research and technology Tehran Tehran Iran (Islamic Republic of)