Determination of Safety and Feasbility of Cell Therapy Using Human-Derived Mesenchymal Stem Cells in Improving Patients with Acute Liver Failure
Design
One group of 5 patients with uncontrolled, clinical trial phase 1
Settings and conduct
Intravenous injection of mesenchymal stem cellsin Shariati hospital and Imam Khomeini hospital in Tehran
Participants/Inclusion and exclusion criteria
Inclusion Criterias:
1. ALF: The occurrence of hepatic encephalopathy is less than 8 weeks after the onset of jaundice in a disease that has no history of known liver disease.
2. All patients with ALF or ACLF at the time of the study admitted to Shariati Hospital and Imam Khomeini Hospital.
Exclusion criteria:
1. Patient dissatisfaction
2. Pregnant patient
3. Age less than 17 years
4. A patient with known active malignancy
Intervention groups
Placenta-derived mesenchymal stem cells is about 1× 106 MSC / Kg by intravenous injection
twice injection in one patient
Main outcome variables
the level of consciousness
Laboratory tests : Coagulation tests (PT, INR), Aminotransferase, Ammoniac level, Bilirubin, Cell count, Lactate, Creatinine / Bun, Na / K, Albumin level, Blood Sugar
General information
Reason for update
Acronym
P-MSCs
IRCT registration information
IRCT registration number:IRCT20190717044241N1
Registration date:2020-02-15, 1398/11/26
Registration timing:registered_while_recruiting
Last update:2020-02-15, 1398/11/26
Update count:0
Registration date
2020-02-15, 1398/11/26
Registrant information
Name
Mahshid Saleh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 7736 5353
Email address
mahshid_saleh@ymail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-12-22, 1398/10/01
Expected recruitment end date
2021-02-19, 1399/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Cell therapy using human-derived placental-derived mesenchymal stem cells in patients with Acute liver failure: clinical trial phase I
Public title
Infusion of human-derived placental-derived mesenchymal stem cells in patients with acute liver failure
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
ALF: The occurrence of hepatic encephalopathy is less than 8 weeks after the onset of jaundice in a disease that does not have a history of known liver disease.
All patients with ALF or ACLF are admitted to hospital at Shariati Hospital and Imam Khomeini Hospital.
Exclusion criteria:
Patient dissatisfaction
Pregnant patient
Age less than 17 years
Patient with known active malignancy
Age
From 17 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
5
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
Iran National committee for Ethics in Biomedical research
Street address
Floor 13, Block A, Ministry of Health & Medical Education Headquarters, Between Zarafashan & South Falamak, Qods Town, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
...........
Approval date
2019-12-25, 1398/10/04
Ethics committee reference number
IR.TUMS.VCR.REC.1398.740
Health conditions studied
1
Description of health condition studied
Acute liver failure
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Type and amount of observed side effects due to placental mesenchymal stem cells in patients with Acute Liver Failure in order to safety assessment for this intervention.
Timepoint
At 24, 48, 72 hours and one month post cell transplantation
Method of measurement
General physical assessments and laboratory tests like blood, serum, and urine analysis.
2
Description
Severity of clinical scores,Consciousness Test
Timepoint
At 24, 48, 72 hours and one month post cell transplantation
Method of measurement
clinical observation by Gastroenterologist
3
Description
assessment of Liver function
Timepoint
At 24, 48, 72 hours and one month post cell transplantation
Method of measurement
PT,INR,ALT,AST,CBC
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Patients with acute liver failure who are transplanted with placenta-derived mesenchymal stem cells that are injected 1–1.5 x 106 Via (IV) intravenous injection.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shariati hospital & Imam Khomeini Hospital
Full name of responsible person
ِِDr Mahdi Mohamad Zadeh
Street address
Tehran Province, Tehran, District 6, Jalal Al Ahmad Highway
City
Tehran
Province
Tehran
Postal code
1411713135
Phone
+98 21 8490 1000
Email
shariatihosp@tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr َMohammad Ali Sahraian
Street address
Imam Khomeini Ave., Hasan Abad Sq., Sina Hospital
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6670 6142
Email
msahrai@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
Proportion provided by this source
50
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
Tehran University of Medical Sciences
Full name of responsible person
Mahshid Saleh
Position
دانشجو دکترا
Latest degree
Master
Other areas of specialty/work
Cell Therapy
Street address
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
Mahshid_saleh@ymail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr Javad Verdi - Dr Mehdi Mohammadnejad
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell Therapy
Street address
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
javadverdi2019@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
مهشید صالح
Position
دانشجو دکترا
Latest degree
Master
Other areas of specialty/work
Cell Therapy
Street address
Tehran Province, Tehran, Eastern side of Tehran University، Italy St, No. 88
City
Tehran
Province
Tehran
Postal code
55469-14177
Phone
+98 21 4305 2000
Email
Mahshid_saleh@ymail.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
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available