A Comparison Study on Safety & Efficacy of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients: A Randomized, Double Blind, Clinical Trial Phase II
Safety of 3 Times Intravenous Transplantation of َAllogeneic Different Sources Derived-Mesenchymal Stem Cells in ARDS Patients
Design
A uncontrolled, parallel, double-blind, randomized, clinical trial, phase II
4 groups, 3 patients in each group, totally 12 patients
4 cell interventional groups
12 months follow-up
Settings and conduct
We carry out a randomized, double-blind phase II trial of 3 times Intravenous infusion of allogeneic mesenchymal stem cells derived from different sources for treatment in 12 ARDS patients, 3 bone marrow derived MSC, 3 adipose derived MSC, 3 wharton's jelly derived MSC and 3 amniotic membrane derived MSC, in a 1:1:1:1 randomization. Each patient receives 3 Intravenous infusions every other day. Patients will be followed daily during 7 days after the first transplantation, Then at 2 week, 4 weeks, 3, 6 and 12 months.
Three doses of 200×10#6 cells are intravenously infused as a naturally dropped single dose over 15-20 minutes in every other day. The cell products will be supplied by CELLTECH company and Royan institute. The products will be transferred to Baqiyatallah hospital and transplanted.
Participants/Inclusion and exclusion criteria
• Aged between 18 to 65 years
• Male or female
• Signed informed consent voluntarily
• Confirmed ARDS
Intervention groups
First Intervention group: Wharton's jelly derived mesenchymal stem cells
Second Intervention group: Amniotic membrane derived mesenchymal stem cells
Third Intervention group: Bone marrow derived mesenchymal stem cells
Forth Intervention group: Adipose derived mesenchymal stem cells
Main outcome variables
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
General information
Reason for update
Acronym
Allo-MSCs-ARDS
IRCT registration information
IRCT registration number:IRCT20080901001165N44
Registration date:2020-03-28, 1399/01/09
Registration timing:prospective
Last update:2020-03-28, 1399/01/09
Update count:0
Registration date
2020-03-28, 1399/01/09
Registrant information
Name
Yunes Panahi
Name of organization / entity
Baqiyatallah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8821 1524
Email address
yunespanahi@bmsu.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-03-29, 1399/01/10
Expected recruitment end date
2020-08-31, 1399/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
A Comparison Study on Safety & Efficacy of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients: A Randomized, Double Blind, Clinical Trial Phase II
Public title
A Comparison Study of Repeated Intravenous Infusion of Allogeneic Mesenchymal Stem Cell from Different Sources in ARDS Patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Signed informed consent voluntarily
Confirmed ARDS
SOFA score between 2-3 point
PaO2/FIO2 ≤ 300 mmHg
Mild to Moderate pneumonia/ stay in the ICU <48 hours
Pulmonary imaging shows that the focus progress > 50% in 24-48 hours
Exclusion criteria:
Co-Infection of HIV, tuberculosis, influenza virus, adenovirus and other respiratory infection virus
Liver or kidney SOFA score of more than 3 points; combined with other organ failure
Patients with malignant tumor
Pregnant or lactating women
Uncontrolled underling diseases
Pulmonary obstructive pneumonia, severe pulmonary interstitial fibrosis, allergic alveolitis, and other known viral pneumonia or bacterial pneumonia
In vitro life support (ECMO, ECCO2R, RRT)
Age
From 18 years old to 65 years old
Gender
Both
Phase
1-2
Groups that have been masked
Participant
Care provider
Outcome assessor
Sample size
Target sample size:
12
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
There are the same cell bags for infusion during study. Clean room staff, DSMB and data statistician just aware of their contain. So, the mentioned people (clinicians for assessment, health care system staff for infusion and patients) will not inform about the type of intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
National Institute for Medical Research Development
Street address
No. 21, Besat Ave, West Fatemi Ave, Tehran
City
Tehran
Province
Tehran
Postal code
۱۴۱۹۶۹۳۱۱۱
Approval date
2020-03-25, 1399/01/06
Ethics committee reference number
IR.NIMAD.REC.1399.002
Health conditions studied
1
Description of health condition studied
Acute respiratory distress syndrome (ARDS)
ICD-10 code
J80
ICD-10 code description
Acute respiratory distress syndrome
Primary outcomes
1
Description
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
Timepoint
Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention
Method of measurement
Fill Common Terminology Criteria for Adverse Events (CTCAE) Form
Secondary outcomes
1
Description
PaO2/FiO2 assessment
Timepoint
Before Intervention, Day 0 (First Intervention) till Day 7, Day 14, Day 28, 3 Moths, 6 Months and 12 months after intervention
Method of measurement
Ventilator
Intervention groups
1
Description
First Intervention group: Wharton's jelly derived mesenchymal stem cells
Category
Treatment - Drugs
2
Description
Second Intervention group: Amniotic membrane derived mesenchymal stem cells
Category
Treatment - Drugs
3
Description
Third Intervention group: Bone marrow derived mesenchymal stem cells