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IRCT20190101042197N1 IRCT 2020-08-24 Royan Stem cell Technology Co. Application of Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers due to the cutaneous chronic GVHD Safety and Effectiveness evaluation of Allogeneic Cord Blood Platelet Gel (CBPG) for the treatment of non-healing skin ulcers/erosion due to the cutaneous chronic GVHD: A Randomize Clinical Trial (Pilot study) 2020-07-22 anticipated 15 Complete https://irct.ir/trial/50402 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: In this study, the Stratified Block Randomization method is used for randomization in the intervention and control groups. Since patients with different intensities are in the study, to ensure the equality of the number of people assigned to the two groups, the block randomization method is used in each category. Also, the blocks used are of sizes 2 and 4, and based on the sample size of 15 and the probable number of participants in the study with any severity of the disease, blocks with the appropriate volume are used to generate random codes. In order to place patients in control and intervention groups, a random sequence table is created with the SAS 9.1 software. 1 Unhealed skin ulcers in patients with chronic GVHD skin complications. Intervention 1: Intervention group: Platelet gel from allogeneic cord blood. Cord blood is taken from the umbilical cord blood bank of Bon Yakhte Royan Co. and then in the clean room of the Pediatric Cell Therapy Research Center, platelet gel is prepared from it. The gels are administered up to 6 times every 5 days for each patient with chronic GvHD skin ulcer and are classified as non-responder if no improvement of up to 50% is achieved after this number of treatments. Samples are taken from the corners of the wounds and tissue granulation is examined in a pathology laboratory. The surface of the wounds is imaged and its reduction is examined. Intervention 2: Control group: The wounds of the control group will be dressed in sterile conditions using Vaseline gas after washing. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Dr. Rashin Mohseni
Gharib Ave, Keshavarz BLVD, Children's Medical Center
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 8444 rashin_mohseni@yahoo.com Tehran University of Medical Sciences scientific Dr. Amir Ali Hamidieh
Children's Medical Center, Gharib Ave, Keshavarz Blvd, Tehran
Tehran Iran (Islamic Republic of) 1419733151 +98 21 6694 8444 aahamidieh@tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Existence of chronic GvHD criteria after allogeneic hematopoietic stem cell transplantation Wounds in the upper, lower and trunk Wound surface area more than 2 cm2 and less than 5 cm2 with at least 6 weeks durability Wound grading is 2 and 3. Minimum age one year and maximum 15 years 1 year 15 years Both Other diseases such as diabetes, allergies, coagulopathies or underlying diseases that involve the skin Wounds are small (less than 1 cm) or very large (more than 5 cm) Wound grade is 1 or 4. Lesions on the face and neck D89.811 Chronic graft-versus-host disease Treatment - Other Treatment - Other Intervention group: Platelet gel from allogeneic cord blood. Cord blood is taken from the umbilical cord blood bank of Bon Yakhte Royan Co. and then in the clean room of the Pediatric Cell Therapy Research Center, platelet gel is prepared from it. The gels are administered up to 6 times every 5 days for each patient with chronic GvHD skin ulcer and are classified as non-responder if no improvement of up to 50% is achieved after this number of treatments. Samples are taken from the corners of the wounds and tissue granulation is examined in a pathology laboratory. The surface of the wounds is imaged and its reduction is examined. Control group: The wounds of the control group will be dressed in sterile conditions using Vaseline gas after washing. Reduce wound surface area. Timepoint: At the beginning of the study and 7, 15 and 30 days after the start. Method of measurement: Direct view. Causes severe allergic reactions. Timepoint: 1, 3 and 7 days after the intervention. Method of measurement: Direct view. Infection. Timepoint: One week after intervention. Method of measurement: Sampling. Reduced pain. Timepoint: One month after intervention. Method of measurement: direct examination. Normal physical activity. Timepoint: 6 month after intervention. Method of measurement: Direct examination and observation. Royan Stem cell Technology Co. Approved 2020-07-11 Ethics Committee in Research of Children's Medical Center-Tehran University of Medical Sciences Childrens Medical Center, Gharib Ave, Keshavarz Blvd, Tehran Tehran Tehran Iran (Islamic Republic of)