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IRCT20080728001031N24 IRCT 2018-05-30 Iranian academic center for education culture and research Safety and efficacy of cell therapy in psorisis Safety and efficacy of transplantation of adipose derived stem cells for skin lesions in patients with plaque psoriasis- phase I clinical trial 2017-04-04 anticipated 5 Complete https://irct.ir/trial/31386 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 products with different doses are delivered to the physician with code numbers. Then the dressings will be placed on the patient's lesion 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. For this purpose, the patient's lesions are divided into an intervention and control group based on the randomization table and the cell sample or placebo is sent to the physician with a code and the physician performs the injections according to the product label. 1 Psoriasis. Intervention 1: Intervention group 1: Single intra-dermal injection of 1 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company. Intervention 2: Intervention group 2: Single intra-dermal injection of 3 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company. 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: amir.bajouri@royaninstitute.org How to obtain: The request will be assessed by research committee of Royan Institute which will be taken around2 months Comments:
public Amir Bajouri
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2356 2173 amir.bajouri@royaninstitute.org Iranian academic center for education culture and research scientific Nasser Aghdami
Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
Tehran Iran (Islamic Republic of) 1665664511 +98 21 2356 2173 nasser.aghdami@royaninstitute.org Iranian academic center for education culture and research Iran (Islamic Republic of) Chronic plaque psoriasis for at least 6 months plaque severity of moderate to severe (grade 3-5) Psoriasis Area Severity Index (PASI) less than 12 No response to standard treatments No incidence of new lesion or increase in size of previous lesions during past 6 months 18 years no limit Both Other types of psoriasis include pustular, erythrodermic, gotate, and drug induced Immunosuppressive drugs over the past 4 weeks or topical medications other than moisturizing lotions in the 2 past weeks Severe underlying disease (including liver, kidney and heart failure), increased liver enzymes more than 3 times normal and creatinine more than 2 high and uncontrolled blood pressure Pregnancy or lactation diabetes mellitus Hepatitis B, C or HIV Patients with immunodeficiency Patients with malignancy Disabling disease Systemic or injection site infection L40 Psoriasis Treatment - Drugs Treatment - Drugs Intervention group 1: Single intra-dermal injection of 1 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company. Intervention group 2: Single intra-dermal injection of 3 million adipose-derived stromal cells per cm2 of plaque (based on the results of Phase I study) into 0.5 ml of normal saline per cm2 of plaque and follow up to 6 months after injection. The cells are provided by Cell Tech Pharmed company. Pain. Timepoint: intervention start date up to 6 months. Method of measurement: Pain intensity scale. Redness severity. Timepoint: intervention start date up to 6 months. Method of measurement: Physical examination. Lesion severity (grade 0-5). Timepoint: Before intervention, every week up to 1 month, and every month up to 6 months. Method of measurement: evaluator assessment. Iranian academic center for education culture and research Approved 2015-04-15 Ethics committee of Royan infertility institute Royan institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway Tehran Tehran Iran (Islamic Republic of)