Results assessment of autologous implantation of human Adipose drived stem cells in external anal sphincter and fecal incontinence: a phase II clinical trial
Results assessment of autologous implantation of human Adipose drived stem cells in external anal sphincter and fecal incontinence
Design
A block randomized, double blinded, case controlled clinical trial with a parallel group design of 30 patients in two groups: control group (n=15) and cell group (n=15), enrolled between Jun 2018 and Jun 2020, and followed for six months
Settings and conduct
This study will be done in Hazrate Rasoole Akram Hospital, Tehran, Iran. After human adipose derived stem cells isolation and confirmation, surgical repair of external anal sphincter will be done. Then, 20 millions cells implantation in to external sphincter muscle in cell therapy group and placebo injection in control group will be done. Two months after intervention, fecal incontinence by wexner schedule, muscle morphology by sonography and muscle electrical activity by electromyography will be examined. The patients, researchers and the surgeon are blind to the type of treatment (double blind).
Participants/Inclusion and exclusion criteria
Inclusion criteria:
1-Age >25 years
2-Wexner score ≥ 8
3-Confirmation of external anal sphincter defect with endorectal ultrasonography
4-Patient consent for inclusion
Exclusion criteria:
1-Pregnancy and breastfeeding
2-Participating in other trials within the past 30 days
3-History of artificial sphincter
4-Vaginal delivery within the past 6 months
5-Presence of chronic diseases
6-Autoimmune disease
Intervention groups
Intervention in cell group:
External anal sphincter muscle repair and 20 milions hADSCs ( suspended in 3 ml Phosphate Buffer Solution) implantation in the external anal sphincter
Intervention in control group:
External anal sphincter muscle repair and 3ml placebo Solution (Phosphate Buffer Solution) injection in the external anal sphincter
Main outcome variables
Wexner Score; Rate of wound closure
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20160201026316N3
Registration date:2018-07-26, 1397/05/04
Registration timing:registered_while_recruiting
Last update:2018-07-26, 1397/05/04
Update count:0
Registration date
2018-07-26, 1397/05/04
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
Expected recruitment start date
2018-06-30, 1397/04/09
Expected recruitment end date
2020-06-29, 1399/04/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Results assessment of autologous implantation of human Adipose drived stem cells in external anal sphincter and fecal incontinence: a phase II clinical trial
Public title
Stem Cell therapy on human Fecal incontinence
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age >25 years
Wexner score ≥ 8
Confirmation of external anal sphincter defect with endorectal ultrasonography
Patient consent for inclusion
Exclusion criteria:
Pregnancy and breastfeeding
Participating in other trials within the past 30 days
History of artificial sphincter
Vaginal delivery within the past 6 months
Presence of chronic diseases
Autoimmune disease
Age
From 25 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Care provider
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
A permuted block randomization (block size 3) is used to implement the random allocation sequence without stratification for baseline characteristics. An independent physician generate the random allocation sequence by a computer-based program, enrolled participants, and assigned participants to interventions.
Blinding (investigator's opinion)
Double blinded
Blinding description
Four separate researchers prepare the suspensions, carry out the treatment administration, record patients’ data, and data analysis. The patients and the surgeons who perform the surgery, sonographic, and physical examinations are blind to the type of treatment (double blind). To ensure the blinding of the surgeon to the type of treatment, the cell suspension and placebo are both prepare in packages which appeared to be the same.
Placebo
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
Wexner Schedule (Standard schedule for assessment of fecal incontinence according to patient history)
2
Description
Rate of wound closure
Timepoint
Immediately after surgery to wound closure
Method of measurement
Experienced surgeon view
Secondary outcomes
1
Description
External anal sphincter action potential record in the defect site
Timepoint
Two months after intervention
Method of measurement
Electromyography
2
Description
External anal sphincter morphology
Timepoint
Two months after intervention
Method of measurement
Endorectal Sonography
3
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: External anal sphincter muscle repair and 20 milions hADSCs ( suspended in 3 ml Phosphate Buffer Solution) implantation in the external anal sphincter is done.
Category
Treatment - Other
2
Description
Control group: External anal sphincter muscle repair without implantation in the external anal sphincter is done.
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
Tehran
Province
Tehran
Postal code
1445613131
Phone
+98 21 6655 4790
Fax
+98 21 6655 4790
Email
Bahar1167@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Dr. Kazem malekouti
Street address
Vice Chancellor for research of Iran University of Medical Sciences, next to Milad Tower, Shahid Hemmat Highway, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8670 2108
Fax
Email
research@iums.ac.ir
Web page address
http://res.iums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?