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Safety and efficacy of placental mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients

Protocol summary

Study aim
Evaluating of safety and efficacy of placental mesenchymal stem cells-derived exosomes in alleviating symptoms in severe refractory inflammatory bowel disease patients
Design
Clinical trial without control group, without randomization, open label, sample size: 12, considering attrition: 15, phase I and II
Settings and conduct
Patients with severe refractory inflammatory bowel disease who refer to Tajrish Martyrs Hospital, on the first day, receive 3 vials of placental mesenchymal stem cells-derived exosome (equivalent to 1011 particles or 250-300 micrograms of exosomes) with an interval of 8 hours. Then a maintenance dose vial of exosome is injected daily on days 2, 3, 10 and 21. Then, from the first dose of exosome until 3 months after the injection of the last dose, clinical symptoms and laboratory tests will assessed.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Ulcerative colitis and/or Crohn's disease for at least 6 months with refractory, or intolerance, or contraindication to use with monoclonal antibodies/Highly active Crohn's disease with a Crohn's disease index greater than 450 and/or a simple endoscopic score ≥ 8 (or ≥ 6 for isolated intestinal disease) Exclusion criteria: Using common immunomodulators in the past 4 weeks
Intervention groups
Intervention group: Injection of placental mesenchymal stem cells-derived exosomes: 3 of exosomes (equivalent to 1011 particles or 250-300 micrograms of exosome) on day 1, with an interval of 8 hours, then one vial of exosome maintenance dose daily on days 2, 3, 10 and 21 slowly ( 5 to 10 minutes) into the central vein
Main outcome variables
The percentage of patients who show adverse effects during or after exosome injection. Response to treatment (based on clinical and laboratory tests).

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20230801058996N5
Registration date: 2024-06-22, 1403/04/02
Registration timing: prospective

Last update: 2024-06-22, 1403/04/02
Update count: 0
Registration date
2024-06-22, 1403/04/02
Registrant information
Name
Elham Roshandel
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 5798 4000
Email address
elham.roshandel@sbmu.ac.ir
Recruitment status
recruiting
Funding source
Expected recruitment start date
2024-07-22, 1403/05/01
Expected recruitment end date
2027-07-23, 1406/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy of placental mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients
Public title
Mesenchymal stem cells-derived exosomes in severe refractory inflammatory bowel disease patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Ulcerative colitis and/or Crohn's disease for at least 6 months with refractory, or intolerance, or contraindication to use with monoclonal antibodies Highly active Crohn's disease with a Crohn's disease index greater than 450 and/or a simple endoscopic score ≥ 8 (or ≥ 6 for isolated intestinal disease)
Exclusion criteria:
Using common immunomodulators in the past 4 weeks
Age
From 18 years old to 75 years old
Gender
Both
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 12
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
Ethics committee of Shahid Beheshti University of medical Sciences
Street address
Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2024-05-12, 1403/02/23
Ethics committee reference number
IR.SBMU.REC.1403.003

Health conditions studied

1

Description of health condition studied
Ulcerative colitis
ICD-10 code
K51
ICD-10 code description
Ulcerative colitis

2

Description of health condition studied
Crohn's disease
ICD-10 code
K50
ICD-10 code description
Crohn disease

Primary outcomes

1

Description
The percentage of patients who show adverse effects during or after exosome injection.
Timepoint
From the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose.
Method of measurement
Patient statements and medical team examinations in regular patient visits to the gastroenterology clinic for follow-up.

2

Description
Response to treatment (based on clinical and laboratory tests).
Timepoint
From the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose.
Method of measurement
Regular patient examination in gastroenterology clinic for follow-up

Secondary outcomes

1

Description
Evaluating the progress of the disease using the Crohn's disease activity index for Crohn's disease and Myoscore for ulcerative colitis, the 36-item questionnaire for improving the quality of life, measuring fecal calprotectin, CRP, short chain fatty acids, endoscopy and biochemical tests
Timepoint
From the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose.
Method of measurement
Regular patient examination in gastroenterology clinic for follow-up

Intervention groups

1

Description
Intervention group: Injection of placental mesenchymal stem cells-derived exosomes: On day 1, 3 vials of exosomes (equivalent to 1011 particles or 250-300 micrograms of exosome) with an interval of 8 hours, then one vial of exosome maintenance dose daily on days 2, 3, 10 and 21 slowly ( 5 to 10 minutes) into the central vein
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Shohadaye Tajrish hospital
Full name of responsible person
Ali Pirsalehi
Street address
Tajrish Square, Shahdari Street
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 21 2271 8000
Fax
+98 21 2271 8000
Email
pr-shohada@sbmu.ac.ir
Web page address
https://shmc.sbmu.ac.ir/

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Aarabi street, Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Fax
+98 21 2243 9872
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Javidan Motaher Charity Foundation of Tehran
Proportion provided by this source
50
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
Other

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Aarabi street, Daneshjou Boulevard, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9872
Fax
+98 21 2243 9872
Email
info@sbmu.ac.ir
Web page address
https://sbmu.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
No
Title of funding source
Pharmed Behin Azma
Proportion provided by this source
50
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
Other

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professorاستادیار
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Elham Roshandel
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Aarabi street, Yaman street, Chamran highway
City
Tehran
Province
Tehran
Postal code
1985711151
Phone
+98 21 2303 1658
Fax
+98 21 2303 1658
Email
elham.roshandel@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Due to the confidentiality of patient information
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
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
Evaluating the progress of the disease using the Crohn's disease activity index for Crohn's disease and Myoscore for ulcerative colitis, the 36-item questionnaire for improving the quality of life, measuring fecal calprotectin, CRP, short chain fatty acids, endoscopy and biochemical tests from the first dose of exosome infusion until 3 months on days 7, 30, 60 and 90 after the last dose regular patient examination in gastroenterology clinic for follow-up
When the data will become available and for how long
Data files would be accessible after publication.
To whom data/document is available
Data files would be accessible to both academic researchers and industrial developers.
Under which criteria data/document could be used
Access to the data file will be provided for academic researchers to study. Data analysis is possible for use in meta-analysis review articles. Authentication of the applicant and provision of an academic email is required to access the data file.
From where data/document is obtainable
To receive the data file, please refer to the person in charge of the trial (Dr. Elham Roshandel): E-mail: elham.roshandel@gmail.com Phone number: 00982123031658 Address: Hematopoietic stem cell research center, Yas administrative complex, 4th floor, Taleghani Hospital, Aarabi street, Yaman street, Chamran highway, Tehran.
What processes are involved for a request to access data/document
The applicant must state his/her request accurately and completely. The requested data will be provided within ten working days after receiving the request.
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