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IRCT20080901001159N26 IRCT 2019-08-18 مرکز تحقیقات پوست و سلول های بنیادی دانشگاه علوم پزشکی تهران Cell therapy in diabetic foot ulcer Comparison the safety and efficacy of Adipose derived Stromal Cells -Seeded acellular dermal matrix and Adipose derived Stromal Cells injections in patients with diabetic foot ulcer resistant to standard care: Randomized clinical trial phase I/II 2019-07-23 anticipated 30 Complete https://irct.ir/trial/39568 interventional Randomization: Randomized, Blinding: Not 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, cell or non cell based dressings are delivered to the physician with code numbers. Then the cell product or dressings will be placed on the patient's wound based on randomization number box. 1-2 diabetic foot ulcer. Intervention 1: Intervention group: Silicone dressing (monlyke company) and ADM (Iranian tissue product company) with allogenic adipose-derived stromal cells, 1 million cells/cm2 of wound, every 2 weeks till complete wound closure. Intervention 2: Intervention group: allogenic adipose-derived stromal cells, 1 million cells/cm2 of wound, every 2 week still complete wound closure. Intervention 3: Control group: silicon foam (monlyke company), every 2 weeks till complete wound closure. 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
Maryam alley, Pasha Zahari st, South Kamranieh
Tehran Iran (Islamic Republic of) 16635148 +98 21 2356 2173 bajouri_md@yahoo.com Tehran University of Medical Sciences 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) Age 18 -60 Type 1 or Type 2 diabetes Able and willing to provide consent and agrees to comply with study procedures and follow-up evaluations Ulcer size 2-20 cm2 Ulcer duration of more than 4 weeks, unresponsive to standard wound care No clinical signs of infection Serum creatinine <3 mg/dl HbA1c <12% ABI between 0⋅7 and 1⋅2 18 years 60 years Both wound duration of >52 weeks without intermittent healing Index ulcer probing to tendon, muscle, capsule or bone Currently receiving radiation or chemotherapy Known or suspected malignancy of current ulcer Diagnosis of autoimmune connective tissue disease Use of biomedical/topical growth factor within previous 30 days Pregnant or breast feeding Taking medications considered to be immune system modulators Allergy or known sensitivity to Gentamicin, Streptomycin or bovine collagen Wounds improving more than 20% over the 4-week run-in period of the trial using standard of care. Patient taking Cox-2 inhibitors. HBV, HCV or HIV positive. E08.621 Diabetes mellitus due to underlying condition with foot ulcer Treatment - Other Treatment - Other Treatment - Devices Intervention group: Silicone dressing (monlyke company) and ADM (Iranian tissue product company) with allogenic adipose-derived stromal cells, 1 million cells/cm2 of wound, every 2 weeks till complete wound closure Intervention group: allogenic adipose-derived stromal cells, 1 million cells/cm2 of wound, every 2 week still complete wound closure Control group: silicon foam (monlyke company), every 2 weeks till complete wound closure 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. Skin and Stem Cells Research Center of Tehran University of Medical Sciences Approved 2018-12-15 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)