Red color represents old content. It may be empty showing addition in the new version.
Green color represents new content. It may be empty showing deletion in the new version.
Inline
Side by side
Added new contents,
deleted old contents,contents that are not changed.
New table contents
New table contents
Old table contents
Old table contents
Unchanged contents
Unchanged contents
Added new contents, contents that are not changed.
Deleted old contents, contents that are not changed.
Old table contents
Old table contents
Unchanged contents
Unchanged contents
New table contents
New table contents
Unchanged contents
Unchanged contents
General information
empty
empty
empty
empty
Sponsors / Funding sources
#1
contact.organization_id:
Name of organization / entity - English: Skin & Stem Cell Research Center of Tehran Medical Science University
Name of organization / entity - Persian: مركز تحقيقات پوست و سلول هاي بنيادي دانشگاه علوم پزشكي تهران
Full name of responsible person - English: Prof. Mohammadali Nilforoushzadeh
Full name of responsible person - Persian: پروفسور محمد علی نیلفروش زاده
Street address - English: Street address Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Street address - Persian: ايران تهران کامرانیه جنوبی، کوچه مریم، مرکز تحقیقات پوست و سلولهای بنیادي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1937957511
Phone: +98 21 2220 1710
Fax: +98 21 2220 1710
Email: dr_nilforoush@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Prof. Mohammadali Nilforoushzadeh
Full name of responsible person - Persian: پروفسور محمد علی نیلفروش زاده
Street address - English: Street address Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Street address - Persian: ايران تهران کامرانیه جنوبی، کوچه مریم، مرکز تحقیقات پوست و سلولهای بنیادي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Country: Iran (Islamic Republic of)
Postal code: 1937957511
Phone: +98 21 2220 1710
Fax: +98 21 2220 1710
Email: dr_nilforoush@yahoo.com
Web page address:
contact.organization_id: Name of organization / entity - English: Skin & Stem Cell Research Center of Tehran Medical Science University Name of organization / entity - Persian: مركز تحقيقات پوست و سلول هاي بنيادي دانشگاه علوم پزشكي تهران Full name of responsible person - English: Prof. Mohammadali Nilforoushzadeh Full name of responsible person - Persian: پروفسور محمد علی نیلفروش زاده Street address - English: Street address Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran Street address - Persian: ايران تهران کامرانیه جنوبی، کوچه مریم، مرکز تحقیقات پوست و سلولهای بنیادي City - English: Tehran City - Persian: تهران Province: Tehran Country: Iran (Islamic Republic of) Postal code: 1937957511 Phone: +98 21 2220 1710 Fax: +98 21 2220 1710 Email: dr_nilforoush@yahoo.com Web page address:
Person responsible for updating data
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Elham Torkamaniha
Full name of responsible person - Persian: الهام تركمني ها
Position - English: Master of science in biotechnology
Position - Persian: كارشناسي ارشد بيوتكنولوژي
Latest degree: master
Area of specialty/work:
Area of specialty/work title - English: Skin& Stem Cell
Area of specialty/work title - Persian: پوست و سلول هاي بنيادي
Street address - English: Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
Street address - Persian: ايران تهران، کامرانیه جنوبی، بن بست مریم مركز پوست و سلول هاي بنيادي
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1937957511
Phone: +98 21 2220 1710
Mobile: +98 912 250 2130
Fax:
Email: elham_torkamaniha@yahoo.com
Web page address:
Name of organization / entity - English:
Name of organization / entity - Persian:
Full name of responsible person - English: Alireza Shoaehassani
Full name of responsible person - Persian: علیرضا شعاع حسنی
Position - English: PhD of Applied Cell Scieances
Position - Persian: دکترای تخصصی علوم سلولی کاربردی
Latest degree: phd
Area of specialty/work:
Area of specialty/work title - English: Applied Cell Scieances
Area of specialty/work title - Persian: علوم سلولی کاربردی
Street address - English: No 132 - Gandi st - Vanak
Street address - Persian: ايران تهران، میدان ونک گاندی جنوبی پلاک 132 طبقه 1 واحد 8
City - English: Tehran
City - Persian: تهران
Province: Tehran
Province - English:
Province - Persian:
contact.provinces_available: 1
Country: Iran (Islamic Republic of)
Postal code: 1516748611
Phone: +98 21 8819 6540
Mobile: +98 912 145 4878
Fax:
Email: cell.therapy@yahoo.com
Web page address:
Name of organization / entity - English: Name of organization / entity - Persian: Full name of responsible person - English: Elham TorkamanihaAlireza Shoaehassani Full name of responsible person - Persian: الهام تركمني هاعلیرضا شعاع حسنی Position - English: MasterPhD of science in biotechnologyApplied Cell Scieances Position - Persian: كارشناسي ارشد بيوتكنولوژيدکترای تخصصی علوم سلولی کاربردی Latest degree: masterphd Area of specialty/work: Area of specialty/work title - English: Skin& StemApplied Cell Scieances Area of specialty/work title - Persian: پوست و سلول هاي بنياديعلوم سلولی کاربردی Street address - English: Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, IranNo 132 - Gandi st - Vanak Street address - Persian: ايران تهران، کامرانیهمیدان ونک گاندی جنوبی، بن بست مریم مركز پوست و سلول هاي بنيادي پلاک 132 طبقه 1 واحد 8 City - English: Tehran City - Persian: تهران Province: Tehran Province - English: Province - Persian: contact.provinces_available: 1 Country: Iran (Islamic Republic of) Postal code: 19379575111516748611 Phone: +98 21 2220 17108819 6540 Mobile: +98 912 250 2130145 4878 Fax: Email: elham_torkamanihacell.therapy@yahoo.com Web page address:
Protocol summary
Study aim
the effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.
Design
In this study, there are two groups (intervention and control) that are examined simultaneously is one patient and 15 patients are matched with children's medical center hospital. This intervention is the third phase of the trial. In this intervention, dressings are performed in three times for each patient which are changed on the other days.
Settings and conduct
The location of intervention is in the children 's medical center In this study blindness was not made and all patients and physicians are aware of the type and wound dressing structure.
Participants/Inclusion and exclusion criteria
The wound should be on the hand.The wound must be second degree ,Both of genders can be entered this study.The size of wound should be more than 5 cm2 and less than 10 cm2 ,exclusion criteria :The patients with other diseases such as diabetes, allergy and coagulopathy
Intervention groups
The intervention group consists of people who have wound of GVHD who meet the inclusion criteria mentioned above and receive the desired dressing (platelet gel derived from umbilical cord blood).
The control group is also the same persons in the intervention group and receive routine treatment on the other wound caused by GVHD.
The size of the wound caused by GVHD ,should be more than 5 and less than10 cm*cm on the hand.
Main outcome variables
The effectiveness of platelet gel derived from cord blood on the GVHD wound treatment.
General information
Reason for update
Acronym
--
IRCT registration information
IRCT registration number:IRCT20141007019432N6
Registration date:2018-04-27, 1397/02/07
Registration timing:registered_while_recruiting
Last update:2019-02-14, 1397/11/25
Update count:1
Registration date
2018-04-27, 1397/02/07
Registrant information
Name
Mohammadamir Amirkhani
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 1710
Email address
amirkhani@health.gov.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-11, 1396/12/20
Expected recruitment end date
2019-03-11, 1397/12/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
Public title
Application of Cord Blood Platelet Gel (CBPG) for treatment of skin ulcers due to cutaneous chronic GVHD
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The wound should be on the hand.
The wound that have second degree
Both of genders can be entered this study.
The surface of wound should be more than 5 cm2 and less than 10cm2
Exclusion criteria:
The patients with other systemic diseases such as diabetes, allergy and coagulopathy
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
10
More than 1 sample in each individual
Number of samples in each individual:
2
Each person should have two areas of burn ulcer on his/her hands. one area will recieve the first intervention and the other one will recieve the second intervention
Actual sample size reached:
10
More than 1 sample in each individual
Actual sample size in each individual:
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University Medical Sience
Street address
Tehran University of Medical Sciences, Cross Qods st, Keshavarz Blvd, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417653761
Approval date
2017-12-19, 1396/09/28
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4286
Health conditions studied
1
Description of health condition studied
Wound and GVHD
ICD-10 code
D89.81
ICD-10 code description
Graft-versus-host disease
Primary outcomes
1
Description
Formation of wound granulation tissue
Timepoint
before intervention and 6 days after last intervention
Method of measurement
Pictzar Software
2
Description
Reduction of wound area and depth
Timepoint
Before intervention and 6 day after the last intervention
Method of measurement
Surface and depth of the wound are examined by the pictzar software
Secondary outcomes
1
Description
wound pain
Timepoint
6 days after the first intervention
Method of measurement
Question and answer from the patient
Intervention groups
1
Description
Intervention group: in this study, 15 patients are selected from children's medical center hospital. The size of the wound caused by GVHD, should be more than 5 and less than 10 cm*cm on the hand. One of the wounds of GVHD is treated with new dressing (paletlet gel from the cord blood) and another wound of the same patient (on the hand) is treated with routine treatment at the same time. In this intervention, three dressings in three times are performed for each patient every other days.
Category
N/A
2
Description
Control group: At the same time, the same patients who have another wound on their hands receive dressing including routine treatment (in this group platelet gel derived from umbilical cord blood don't used).
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Skin & Stem Cell Research Center of Tehran University
Full name of responsible person
Mohammad Amir Amirkhani
Street address
Tehran -Iran Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Prof. Mohammadali Nilforoushzadeh
Street address
Street address Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Fax
+98 21 2220 1710
Email
dr_nilforoush@yahoo.com
Web page address
Grant name
Skin & Stem Cell Research Center of Tehran Medical Science University
Grant code / Reference number
Non grant code
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Skin & Stem Cell Research Center of Tehran Medical Science University
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Skin & Stem Cell Research Center of Tehran Medical Science
Full name of responsible person
Mohammad Amir Amirkhani
Position
Consultant
Latest degree
Ph.D.
Other areas of specialty/work
Skin& Stem Cell
Street address
Tehran -Iran Skin & Stem Cell Research Center, Maryam aley, South kamraneye, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2220 1710
Email
Amirkhani2000@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Amirali Hamidieh
Position
Associate professor،Stem Cell and Technology Development
Latest degree
Specialist
Other areas of specialty/work
Hematology and Oncology Stem Cell Transplantation
Street address
Gharib street children's Medical Center of Imam khomeiny Hospital Tehran Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 912 159 3270
Fax
Email
aahamidieh@tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Alireza Shoaehassani
Position
PhD of Applied Cell Scieances
Latest degree
Ph.D.
Other areas of specialty/work
Applied Cell Scieances
Street address
No 132 - Gandi st - Vanak
City
Tehran
Province
Tehran
Postal code
1516748611
Phone
+98 21 8819 6540
Email
cell.therapy@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no further information
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available