1. Safety of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula
2.Efficacy of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula
3.Fistula changes in MR imagings, 12 weeks after treatment
4.Evaluation of quality of life in perianal fistula patient's questionair score before and 12 weeks after treatment
Design
Single group phase 2 of clinical trial design of 15 patients
Settings and conduct
Patients with complex perianal fistula reffered to Imam Khomeini hospital,will be included in the study if they contain inclusion criteria.The fistula was evaluated by clinical examination and MRI and patients fill the quality of life questionair.Exosome injections are performed weekly for consecutive three weeks.Patients will reexamined and fill the questionair and MRI will done 12 weeks later.Recent findings will compare with the initial data.During this period, patients are examine for complications.
Participants/Inclusion and exclusion criteria
Inclusion Criteria :
1.Age between 18-70 years old
2.Occurrence of compex perianal fistula
3.Informed consent
Exclusion Criteria:
1.Active inflammatory bowel disease
2.Synchronous perianal abcess
3.Alcohol,narcotic and stimulant consumption
4.Having active Hepatitis B,C,HIV or TB
5.Peregnancy and lactation
6.Uncontrolled diabetes mellitus
7.Evidence of surgical cotraindication
8.Psychological disorders and noncooperative patient
Intervention groups
Human Placenta Mesenchymal Stem Cells Derived Exosomes injected in fistula tract of patients with complex perianalnal Fisula in 3 weekly episodes and it's safety and efficacy was evaluated.
Main outcome variables
Discharge amount; External orifice reepithelialisation; Inflammation,discharge and abcess larger than 2 cm in MR imaging; Quality of life questionair score
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20211212053361N1
Registration date:2021-12-22, 1400/10/01
Registration timing:registered_while_recruiting
Last update:2021-12-22, 1400/10/01
Update count:0
Registration date
2021-12-22, 1400/10/01
Registrant information
Name
Mohsen Ahmadi Tafti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1573
Email address
smahmadit@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-12-22, 1400/10/01
Expected recruitment end date
2022-03-20, 1400/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of Injection of Human Placenta Mesenchymal Stem Cells Derived Exosomes for treatment of complex Anal Fistula
Public title
Safety and efficacy of exosome Injection in perianal fistula
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 18-70 years old
Complex perianal fistula
Informed consent
Exclusion criteria:
Active inflammatory bowel disease
Synchronous perianalabcess
Alcohol, narcotic and stimulant consumption
Having active hepatitis B,C, HIV or TB
Pregnancy and lactation
Uncontrolled diabetes mellitus
Evidence of surgical contraindication
Psychological disorders and noncooperative pateint
Age
From 18 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
15
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Biomedical Research Ethics Committee
Street address
Tohid square, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-12-01, 1400/09/10
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.360
Health conditions studied
1
Description of health condition studied
Complex perianal fistula
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
discharge amount
Timepoint
before and during and 12 weeks after the study
Method of measurement
due to pateint's history
2
Description
External orifice reepithelialisation
Timepoint
before and 12 weeks after the study
Method of measurement
clinical examination and MRI
3
Description
Inflammation and abcess larger than 2 cm
Timepoint
before and 12 weeks after the study
Method of measurement
MRI
4
Description
Quality of life questionair score
Timepoint
before and 12 weeks after the study
Method of measurement
Quality of life questionair in perianal fistula patients
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital complex
Full name of responsible person
Seyed Mohsen Ahmadi Tafti
Street address
Tohid Square, Imam Khomeini Hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1657
Fax
Email
smahmadit@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Akbar fotouhi
Street address
Tohid Square, Imam Khomeini hospital complex
City
Tehran
Province
Tehran
Postal code
1419733141
Phone
+98 21 6658 1657
Email
smahmadit@sina.tums.ac.ir
Web page address
https://vcr.tums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?