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Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients

Protocol summary

Study aim
Evaluation of the effectiveness of exosome therapy in the healing of fistulas 3 and 6 months after injection
Design
Parallel, single blinded, 2 groups, 20, clinical trial phase I and II
Settings and conduct
This study will be performed in the colorectal surgery department at Imam Khomeini Hospital (Tehran University of Medical Sciences)
Participants/Inclusion and exclusion criteria
Inclusion criteria Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with anti TNF, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab and anti TNF, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of drug therapy and surgery, without any success Exclusion criteria Patients with immunodeficiency disorders/disease Patients with history of malignancy Patient dissatisfaction Patients in need of surgery Severe co-morbidities (e.g., renal failure, liver failure, etc.) Cerebral Damage
Intervention groups
the injection of exosome
Main outcome variables
- Evaluation of clinical improvement of fistula in patients with Crohn's disease administrated with placental MSCs-derived exosomes in 3 and 6 months after injection. - Comparison fistula healing in patients with control using MRI data treating with placental MSCs-derived exosomes in 3 and 6 months after injection. - Evaluation the recurrence rate of fistula in Crohn's patients with treating with placental MSCs-derived exosomes in 3 and 6 months after injection.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200413047063N3
Registration date: 2021-09-03, 1400/06/12
Registration timing: registered_while_recruiting

Last update: 2021-09-03, 1400/06/12
Update count: 0
Registration date
2021-09-03, 1400/06/12
Registrant information
Name
Masoud Soleimani
Name of organization / entity
Tarbiat Modares University
Country
Iran (Islamic Republic of)
Phone
+98 21 8288 4508
Email address
soleimani.masoud@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-07-31, 1400/05/09
Expected recruitment end date
2022-07-31, 1401/05/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients
Public title
Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with anti TNF, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of treatment with infliximab and anti TNF, without any success Patient with Crohn or other IBD disease, resistance to a 6 month period of drug therapy and surgery, without any success
Exclusion criteria:
Patients with immunodeficiency disorders/disease Patients with history of malignancy Patient dissatisfaction Patients in need of surgery Severe co-morbidities (e.g., renal failure, liver failure, etc.) Cerebral Damage
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 20
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
Iman Khomeini Hospital Complex Committee for Ethics in Biomedical Research- Tehran University of Med
Street address
Imam Khomeini Hospital Complex, Tohid Squre, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1419733141
Approval date
2021-08-04, 1400/05/13
Ethics committee reference number
IR.TUMS.IKHC.REC.1400.184

Health conditions studied

1

Description of health condition studied
Crohn Patients with fistula
ICD-10 code
K50.013
ICD-10 code description
Crohn's disease of small intestine with fistula

Primary outcomes

1

Description
the size of fistula tract
Timepoint
Investigating the fistula healing after 3 and 6 month after injection
Method of measurement
MRI imaging

Secondary outcomes

empty

Intervention groups

1

Description
In a single-arm clinical trial, 6 patients with Crohn disease with perianal fistula are enrolled according to inclusion criteria; after the patients written consent, the patient will receive a dose of mesenchymal derived stem cell exosome ( extracted the same protocol used in previous studies), the exosome will be injected in the tract of the fistula weekly for three weeks, and the patients will be monitored closely for adverse and allergic reactions for 3months.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Tehran University of Medical Sciences, Imam hospital complex
Full name of responsible person
Dr. Seyed Mohsen Ahmadi Tafti
Street address
Keshavars boulevard
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2997
Email
smahmadit@sina.tums.ac.ir

2

Recruitment center
Name of recruitment center
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Masoud Soleimani
Street address
Mirdamad street, Valiasr street
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 8866 6136
Email
masoud.soleimani@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Omid cell and tissue Company
Full name of responsible person
Masoud Soleimani
Street address
No 12, Edvard Brown alley, North Kargar
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8288 4508
Email
Soleim_m@modares.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Omid cell and tissue Company
Proportion provided by this source
80
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
seyed Mohsen Ahmadi Tafti
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
General Surgery
Street address
Keshavars boluvard
City
tehran
Province
Tehran
Postal code
۱۴۱۹۷۳۳۱۴۱
Phone
+98 21 6119 2997
Email
smahmadit@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tarbiat Modares University
Full name of responsible person
Masoud Soleimani
Position
professor
Latest degree
Ph.D.
Other areas of specialty/work
Hematology
Street address
Jalal - al- Ahmad-Chamran High way
City
Tehran
Province
Tehran
Postal code
1415533122
Phone
+98 21 8288 0000
Email
soleim_m@modares.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Hojjatollah Nazari
Position
Research assistant
Latest degree
Master
Other areas of specialty/work
Medical Nanotechnology
Street address
Tehran heart center hospital
City
Tehran
Province
Tehran
Postal code
14117 13138
Phone
+98 21 8802 9733
Email
hojat.nazari92@gmail.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
Safety of injection of placental mesenchymal stem cell derived exosomes for Treatment of resistant perianal fistula in Crohn's patients
When the data will become available and for how long
late 2021
To whom data/document is available
scientific community including medical society and stem cell researchers
Under which criteria data/document could be used
the criteria mentioned in this request
From where data/document is obtainable
direct email
What processes are involved for a request to access data/document
one-three week period
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