Protocol summary

Study aim
Clinical trial Phase IIa, on amelioration of decompensated Liver Cirrhosis with Mesenchymal Stem Cells derived exosome
Design
A phase IIa clinical trial on decompensated liver cirrhosis patients with 15 individuals
Settings and conduct
Upon recruitment clinical information will be obtained via an interview and use of a structured questionnaire. Liver function will be evaluated at baseline, 2 months and 4 months after administration. Patients will be reviewed by a physician at 2 months and 4 months for development of any potential adverse events including hypersensitivity or allergy to MSc derived exosome.
Participants/Inclusion and exclusion criteria
Eligible patients were at least 18-year-old with a clinical and/or pathologic diagnosis of liver decompensated Cirrhosis; Ages Eligible for Study: 18 Years to 75 Years (Adult, Older Adult) ; Sexes Eligible for Study: All (male and female); Able to understand and willing to voluntarily sign an informed consent form (ICF); Child score class B or C.
Intervention groups
15 enrolled patients will receive standard medication plus Msc derived exosome at a final dose of 40mg, one time per week for three weeks.
Main outcome variables
Liver function including CHILD score and MELD score will be evaluated at baseline, 8 weeks and 16 weeks after administration.

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200809048342N3
Registration date: 2023-03-11, 1401/12/20
Registration timing: prospective

Last update: 2023-03-11, 1401/12/20
Update count: 0
Registration date
2023-03-11, 1401/12/20
Registrant information
Name
Kaveh Baghaei
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 2516
Email address
kavehbaghaei@sbmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-09, 1402/01/20
Expected recruitment end date
2023-08-11, 1402/05/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Clinical Trial Phase IIa, on Amelioration of Decompensated Liver Cirrhosis with Mesenchymal Stem Cells-derived Exosomes
Public title
Effect of Mesenchymal Stem Cells-derived Exosomes in Decompensated Liver Cirrhosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Able to understand and willing to voluntarily sign an informed consent form (ICF) authorization. Males or females between 18-75 years old with a clinically confirmed diagnosis of Liver cirrhosis with any etiology, except viral cirrhosis. Child score class B or C.
Exclusion criteria:
Known cardiovascular disease. a) History of hepatocellular carcinoma (HCC). b) History of malignancy within the past 5 years or ongoing malignancy other than basal cell carcinoma, or resected noninvasive cutaneous squamous carcinoma at the time of Screening visit. c) Active, serious infections that require parenteral antibiotic or antifungal therapy within 30 days prior to Screening visit. Females who are pregnant or breastfeeding. Current or anticipated treatment with radiation therapy, cytotoxic chemotherapeutic agents and immunomodulating agents (such as systemic corticosteroids, interleukins, interferons). Use of any experimental medications within the last 6 months of Screening Visit. Any other clinically significant disorders or prior therapy that, in the opinion of the investigator, would make the subject unsuitable for the study or unable to comply with the dosing and protocol requirements. Weight loss of >5% within 6 months prior to Screening, based on subject's reporting. Currently or participated in a weight loss program within the last 6 months. Any history of bariatric surgery. Diabetes mellitus Type I. Daily alcohol intake >20 ml (2 units)/day for women and 30 ml (3 units)/day for men (on average), as per Alcohol Use Disorders Identification Test (AUDIT) questionnaire at Screening and plan to consume the same alcohol amount referenced above during the trial. Use of any immunosuppressive medication, anti-inflammatory monoclonal antibody treatment, or chronic systemic corticosteroids >10 mg prednisone-equivalent concurrently or within 1 year prior to Screening. Uncontrolled or clinically unstable thyroid disease, in the judgment of the Principal Investigator. Uncontrolled arterial hypertension Any severe, acute, or chronic medical or psychiatric condition that may increase the risk associated with study participation or study drug administration, may interfere with the informed consent process and/or with compliance with the requirements of the study, or may interfere with the interpretation of study results and, in the investigator's opinion, would make the subject inappropriate for entry into this study
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 15
Randomization (investigator's opinion)
Not randomized
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 Science
Street address
Research Institute for Gastroenterology and Liver Diseases, taleghani hospital, Arabi st., Velenjak ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985714711
Approval date
2022-11-28, 1401/09/07
Ethics committee reference number
IR.SBMU.RIGLD.REC.1401.016

Health conditions studied

1

Description of health condition studied
Decompensated Liver Cirrhosis
ICD-10 code
K74
ICD-10 code description
Fibrosis and cirrhosis of liver

Primary outcomes

1

Description
Liver function by MELD score
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Calculation of MELD score based on patient's laboratory values for serum creatinine, bilirubin, international normalized ratio for prothrombin time, and sodium.

2

Description
Liver function by CHILD score
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Calculation of CHILD score based on patient's laboratory values for serum bilirubin, albumin, international normalized ratio for prothrombin time, ascites, and encephalopathy.

Secondary outcomes

1

Description
Change in liver enzyme AST
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Blood test

2

Description
Change in liver enzyme ALT
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Blood test

3

Description
international normalized ratio (INR) for prothrombin time
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Blood test

4

Description
Bilirubin
Timepoint
Baseline, after 2 and 4 months of the trial
Method of measurement
Blood test

Intervention groups

1

Description
Intervention group: patients will receive standard medication plus MSC-derived exosomes at a final dose of 40mg in three weeks. Standard medication includes: a) treatment of the underlying cause of cirrhosis such as drug treatment of hepatitis B and C. b) symptomatic treatment of port complications such as ascites, prevention of variceal bleeding, treatment and prevention of hepatic encephalopathy.
Category
Treatment - Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Gastroenterology and Liver Diseases clinic
Full name of responsible person
Behzad Hatami
Street address
Gastroenterology and Liver Diseases clinic,Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2516
Email
bzd_hatami@yahoo.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mohammadreza Zali
Street address
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2525
Email
nnzali@hotmail.com
Grant name
Research Institute for Gastroenterology and Liver Diseases
Grant code / Reference number
1208
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

2

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
‪Masoud Soleimani‬
Street address
Tehran - Valiasr St., Mirdamad , No. 53 Qabadian West St., School of Advanced Technologies in Medicine
City
Tehran
Province
Tehran
Postal code
0000000000
Phone
+98 21 8866 6136
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
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
30
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

3

Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hatami
Street address
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2516
Email
bzd_hatami@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti University of Medical Sciences
Proportion provided by this source
40
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Behzad Hatami
Position
ََAssistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Gastroeterologist
Street address
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2516
Email
bzd_hatami@yahoo.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Kaveh Baghaei
Position
Assistant professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biology
Street address
Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2516
Fax
Email
kavehbaghaei@sbmu.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Taha Aghajanzadeh
Position
Researcher
Latest degree
Master
Other areas of specialty/work
Medical Biology
Street address
Gastroenterology and Liver Diseases clinic, Research Institute of Gastroenterology & Liver Diseases, Taleghani Hospital, Arabi St. Daneshjo Blvd, Yaman St. Velenjak
City
Tehran
Province
Tehran
Postal code
1985714711
Phone
+98 21 2243 2516
Email
taha.aghajanzadeh@yahoo.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be 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
Part of data which is related to main outcome could be share.
When the data will become available and for how long
starting in 2024
To whom data/document is available
It would be available for people working in academic institutions and those are in businesses can also apply to receive it.
Under which criteria data/document could be used
It is depends on requests.
From where data/document is obtainable
Corresponding: Dr. Behzad Hatami "bhz_hatami@yahoo.com" Dr. Kaveh Baghaei "kavehbaghai@gmail.com"
What processes are involved for a request to access data/document
-Request - Early consideration in 1 week - Conversations - Provide possible request between 2-4 weeks
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