1. Home
  2. Approved trials
  3. » فارسی

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

Protocol summary

Study aim
1- Evaluation of the safety and efficacy of amniotic membrane seeded by allogenic fibroblast and keratinocyte in chronic wounds of patients with dystrophic epidermolysis bullosa 2- comparison of the wound size, severity and recurrent rate in amniotic membrane seeded by allogenic fibroblast and keratinocyte group and amniotic membrane group 3- comparison of the expression of type 7 collagen in amniotic membrane seeded by allogenic fibroblast and keratinocyte group and amniotic membrane group
Design
Randomized, double blinded, controlled, parallel group phase II clinical trial in 20 patients and 6 months follow up
Settings and conduct
In each patient referred to the Skin and Stem Cell Center 2 wounds with 10 to 100 cm square are selected and then randomly covered by the amniotic membrane seeded by allogenic fibroblasts or amniotic membrane alone. The scaffold will be prepared every 4 weeks until complete wound closure. The wounds are evaluated each week for up to 1 month, and then every month, up to 6 months after transplantation, in terms of the severity and extent of the wound, the number of needed scaffolds, the relapse time, and the expression rate of collagen type 7.
Participants/Inclusion and exclusion criteria
Inclusion criteria: 20 patients aged 2-20 years old, Both sexes, Dystrophic type, Multiple skin wounds which are recurrent during 6 months ago Exclusion criteria: Pregnancy or lactating, Arterial or venous defects in recipient site, Immune deficiency, Hemolytic anemia, Chronic malnutrition, Respiratory defects, Diabetes, Local infection of recipient site, Cell transplantation of recipient site during last 1 year, HBV, HCV, and HIV, Malignancy of recipient site
Intervention groups
Amniotic membrane seeded by allogenic skin cells group Amniotic membrane group
Main outcome variables
Wound size, complete wound closure, wound severity, pain intensity, collagen type 7 expression rate

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20080901001159N20
Registration date: 2018-05-04, 1397/02/14
Registration timing: registered_while_recruiting

Last update: 2018-05-04, 1397/02/14
Update count: 0
Registration date
2018-05-04, 1397/02/14
Registrant information
Name
Mohamad Ali Nilforoushzadeh
Name of organization / entity
Skin and Stem Cell Research Center, Tehran University of Medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 2220 5158
Email address
sdlrc@mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-04-21, 1397/02/01
Expected recruitment end date
2018-10-22, 1397/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
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
Public title
Effects of cell therapy in treatment of epidermolysis bullosa
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with 2-20 years old Both sexes Dystrophic type of EB Multiple skin wounds which are recurrent during 6 months ago
Exclusion criteria:
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
Age
From 2 years old to 20 years old
Gender
Both
Phase
2
Groups that have been masked
  • Participant
  • Care provider
  • Investigator
  • Outcome assessor
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Double blinded
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
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 of Medical Sciences
Street address
Keshavarz st, Qods st, Central building of university, 6th floor, deputy for research and technology
City
Tehran
Province
Tehran
Postal code
1416613675
Approval date
2018-01-01, 1396/10/11
Ethics committee reference number
IR.TUMS.VCR.REC.1396.4099

Health conditions studied

1

Description of health condition studied
Epidermolysis bullosa
ICD-10 code
Q81
ICD-10 code description
Epidermolysis bullosa

Primary outcomes

1

Description
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

Secondary outcomes

1

Description
Safety
Timepoint
intervention start date up to 6 months
Method of measurement
Medical history and physical examination

Intervention groups

1

Description
Intervention group: Amniotic membrane seeded by allogenic fibroblast
Category
Treatment - Other

2

Description
Control group: amniotic membrane
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Skin and Stem cell Research Center
Full name of responsible person
Mohammad Ali Nilforooshzadeh
Street address
Maryam alley, Pasha Zahari st, South Kamranieh
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Email
nilforoushzadeh@mui.ac.ir
Web page address
http://skinstemcell.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforooshzadeh
Street address
Vice chancellor for research, Tehran University of Medical Sciences, Enghelab Street, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Email
nilforoushzadeh@mui.ac.ir
Web page address
http://skinstemcell.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
100
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
Iranian academic center for education culture and research
Full name of responsible person
Amir Bajouri
Position
Clinical researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 9, Shaghayegh alley, Banihashem st, Resalat Ave
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2173
Email
bajouri_md@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mohammad Ali Nilforoushzadeh
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Dermatology
Street address
Skin and Stem Cell Research Center, third floor, no 4, Maryam impasse, Kamranieh st, Tehran
City
Tehran
Province
Tehran
Postal code
1937957511
Phone
+98 21 2221 2537
Fax
Email
sdlrc@mui.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iranian academic center for education culture and research
Full name of responsible person
Amir Bajouri
Position
Clinical researcher
Latest degree
Medical doctor
Other areas of specialty/work
General Practitioner
Street address
No 9, Shaghayegh alley, Banihashem st, Resalat Ave
City
Tehran
Province
Tehran
Postal code
16635148
Phone
+98 21 2356 2173
Email
bajouri_md@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All data will be shared after unidentifiable of the patients
When the data will become available and for how long
6 months after paper publication
To whom data/document is available
Academic researchers
Under which criteria data/document could be used
In term of analysis the data related to study outcomes
From where data/document is obtainable
bajouri_md@yahoo.com
What processes are involved for a request to access data/document
The request will be assessed by research committee of Skin and Stem cells research center which will be taken around 1-2 months
Comments
Loading...