Protocol summary

Summary
Objectives: Main objective: Results assessment of human Adipose drived stem cells application in human fecal incontinance Secondary objectives: Record and assessment of wexner score, endorectal sonography and of external anal sphincter electromyography before and two month after cell transplantation Design: 20 patients with anal sphincter defect and incontinence will be randomly divided into 2 groups. The control group will be done to repair the anal sphincter. In cell therapy group will be done to repair the anal sphincter and stem cell transplantation. After two months of stem cell transplantation effect on fecal incontinence will be discussed. Setting and conduct: First, human adipose derived stem cells isolation and confirmation and 6×106 .3ml cells implantation in to external sphincter muscle in cell therapy group will be done. Two months after cell transplantation, incontinence by wexner schedule, muscle morphology by sonography and muscle electrical activity by electromyography will be examined. Major Inclusion and Exclusion criteria: Inclusion criteria: Fecal Incontinence with sphincter deficiency; age between 25 to 55 years Exclusion criteria: Fecal Incontinence without sphincter deficiency; age less than 25 and more than 55 years. Intervention: Intervention group: External anal sphincter muscle repair and 6×106 .3ml cells implantation in the sphincter Control group: : External anal sphincter muscle repair and 3ml PBS injection in the sphincter main outcome measures: wexner score

General information

Acronym
-
IRCT registration information
IRCT registration number: IRCT2016022826316N2
Registration date: 2016-05-07, 1395/02/18
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-05-07, 1395/02/18
Registrant information
Name
Bahar Mahjoubi
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 4453 3404
Email address
mahjoubi.b@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Iran university of medical sciences
Expected recruitment start date
2016-04-20, 1395/02/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Results Assessment of Human Adipose drived Stem Cells Application In Human Fecal Incontinance
Public title
Efficacy of Stem Cells on Human Fecal Incontinance
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Fecal Incontinence with sphincter deficiency; age between 25 to 55 years Exclusion criteria: Fecal Incontinence without sphincter deficiency; age less than 25 and more than 55 years.
Age
From 25 years old to 55 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Triple 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 Iran University of Medical Sciences
Street address
Deputy of Research and Technology, Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Postal code
0098211449614535
Approval date
2016-02-15, 1394/11/26
Ethics committee reference number
IR.IUMS.REC.1394.26001

Health conditions studied

1

Description of health condition studied
Faecal Incontinance
ICD-10 code
R15
ICD-10 code description
Faecal incontinence

Primary outcomes

1

Description
Wexner Score
Timepoint
2 months after intervention
Method of measurement
Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history)

Secondary outcomes

1

Description
Rate of wound closure
Timepoint
Immediately after surgery to wound closure
Method of measurement
Experienced surgeon view

2

Description
External anal sphincter action potential record in the defect site
Timepoint
Two months after intervention
Method of measurement
Electromyography

3

Description
External anal sphincter morphology
Timepoint
Two months after intervention
Method of measurement
Endorectal Sonography

4

Description
Amount of muscle in the external anal sphincter defect site
Timepoint
Two months after intervention
Method of measurement
Image J software

Intervention groups

1

Description
Intervention group: Surgical repair of external anal sphincter and 6×106 .3ml human adipose drived stem cells implantation in the external anal sphincter by Syringe
Category
Treatment - Surgery

2

Description
Control group: Surgical repair of external anal sphincter and PBS (3ml) injection in the External anal sphincter by Syringe
Category
Treatment - Surgery

Recruitment centers

1

Recruitment center
Name of recruitment center
Colorectal Research Center, Iran University of Medical Sciences.
Full name of responsible person
Bahar Mahjoubi
Street address
Colorectal Research Center, Rasoul Akram Hospital, Niayesh Street, SattarKhan Street, Tehran, Iran.
City
Tehan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Vice Chancellor for research of Iran University of Medical Sciences
Full name of responsible person
Dr Seyed Ali Javad Mousavi
Street address
Vice Chancellor for research of Iran University of Medical Sciences, next to Milad Tower,Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Grant name
-
Grant code / Reference number
-
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for research of Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Colorectal Research Center, Iran University of Medical Sciences
Full name of responsible person
Arash Sarveazad
Position
Faculty Member
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh street, Sattarkhan Street, Tehran, Iran.
City
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
Arashsarveazad@gmail.com
Web page address
-

Person responsible for scientific inquiries

Contact
Name of organization / entity
Colorectal Research Center , Iran University of Medical Sciences
Full name of responsible person
Bahar mahjoubi
Position
Colorectal Surgeon, Fellowship
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh Street, Sattarkhan Street, Tehran, Iran
City
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
bahar1167@yahoo.com
Web page address
-

Person responsible for updating data

Contact
Name of organization / entity
Colorectal Research Center, Iran University of Medical Sciences
Full name of responsible person
Arash Sarveazad
Position
Faculty Member
Other areas of specialty/work
Street address
Rasoul Akram Hospital, Niayesh street, Sattarkhan Street, Tehran, Iran.
City
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
Arashsarveazad@yahoo.com
Web page address
-

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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