Protocol summary
-
Study aim
-
Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose-derived mesenchymal stem cells on pain relieving and physical activity improvement, in patients with knee joint osteoarthritis.
-
Design
-
A triple-blind randomized controlled clinical trial phase I/II
-
Settings and conduct
-
First we will recruit 3 patients with osteoarthritis admitted in orthopedic clinic of shafa yahyaiean hospital evaluating safety of allogeneic adipose derived mesenchymal stem cells, and if there were no serious side effects after 3 months, another 90 patients in two groups: case group (allogeneic adipose derived MSCs) and control group (normal saline) will be studied in terms of their positive effects in pain reduction and improvement in physical function.
-
Participants/Inclusion and exclusion criteria
-
Patients with 18 to 65 years old Whose arthritis is detected with MRI and are not affected with chronic diseases or cancer, are recruited.
-
Intervention groups
-
Intra-articular transplantation of 100 millions of allogeneic adipose-derived mesenchymal stromal cells in case group and injection of 3-5 ml NL/S in control group
-
Main outcome variables
-
evaluation of allogeneic adipose derived MSCs transplantation on pain and patient’ physical activity and the thickness of affected cartilage
General information
-
Reason for update
-
-
Acronym
-
-
IRCT registration information
-
IRCT registration number:
IRCT20080728001031N23
Registration date:
2018-04-24, 1397/02/04
Registration timing:
registered_while_recruiting
Last update:
2021-08-26, 1400/06/04
Update count:
1
-
Registration date
-
2018-04-24, 1397/02/04
-
Registrant information
-
-
Recruitment status
-
Recruitment complete
-
Funding source
-
-
Expected recruitment start date
-
2017-03-14, 1395/12/24
-
Expected recruitment end date
-
2019-03-21, 1398/01/01
-
Actual recruitment start date
-
empty
-
Actual recruitment end date
-
empty
-
Trial completion date
-
empty
-
Scientific title
-
Evaluation of safety and efficacy of intra-articular transplantation of allogeneic adipose derived mesenchymal stromal cells in patients with knee joint osteoarthritis An interventional randomized triple-blind placebo controlled clinical trial phase I/II
-
Public title
-
Allogeneic stem cell transplantation in knee joint osteoarthritis
-
Purpose
-
Treatment
-
Inclusion/Exclusion criteria
-
Inclusion criteria:
Patients in the range of 18 to 65 years old
osteoarthritis diagnosed by MRI
Exclusion criteria:
Pregnancy or lactating
Positive tests for HIV, HCV, HBV
Active central or peripheral neurologic disorder
End organ damage or Uncontrolled endocrine disorder
Active respiratory disorder and reaction to sedative drugs
history of cancer
-
Age
-
From 18 years old to 65 years old
-
Gender
-
Both
-
Phase
-
1-2
-
Groups that have been masked
-
- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
-
Sample size
-
Target sample size:
100
-
Randomization (investigator's opinion)
-
Randomized
-
Randomization description
-
Randomized allocation to intervention and control groups
-
Blinding (investigator's opinion)
-
Triple blinded
-
Blinding description
-
Participants would be allocated in case and control groups according to a confidential table of accidental numbers which will be just available for the lab responsible.
Care provider, investigator and outcome assessor are not aware of the substance which injected. In order to eliminate data analyzer's errors, group types would not be uncovered until the results are determined.
-
Placebo
-
Used
-
Assignment
-
Parallel
-
Other design features
-
Block randomization
Ethics committees
1
-
Ethics committee
-
-
Approval date
-
2017-10-10, 1396/07/18
-
Ethics committee reference number
-
IR.ACECR.ROYAN.REC.1396.138
Health conditions studied
1
-
Description of health condition studied
-
cell therapy in osteoarthritis
-
ICD-10 code
-
M15.9
-
ICD-10 code description
-
Polyosteoarthritis, unspecified
Primary outcomes
1
-
Description
-
Side effects
-
Timepoint
-
One week, one month, 3, 6 and 12 months after transplantation
-
Method of measurement
-
Physical examination, adverse effect questionnaire
2
-
Description
-
Joint function
-
Timepoint
-
Before, 3, 6 and 12 months after transplantation
-
Method of measurement
-
WOMAC and KOOS questionnaires for osteoarthritis
Secondary outcomes
1
-
Description
-
Cartilage thickness
-
Timepoint
-
Before and 12 months after transplantation
-
Method of measurement
-
MRI
2
-
Description
-
Molecular and cellular indexes (IL-6, IL-10, TNF-α, IFN-γ, COMP, CTX-II, HA, CS846, CD4, CD3, CD8, CD25)
-
Timepoint
-
Before, one week, 3 and 6 months after transplantation
-
Method of measurement
-
Blood test
3
-
Description
-
Subchondral edema
-
Timepoint
-
Before and 12 months after transplantation
-
Method of measurement
-
MRI
4
-
Description
-
Joint effusion
-
Timepoint
-
Before and 12 months after transplantation
-
Method of measurement
-
MRI
5
-
Description
-
new cartilage formation
-
Timepoint
-
Before and 12 months after transplantation
-
Method of measurement
-
MRI
Intervention groups
1
-
Description
-
Phase I and case group in phase II: intraarticular transplantation of single dose 100 millions of allogeneic adipose derived mesenchymal stem cells
-
Category
-
Other
2
-
Description
-
Control group (phase II): intraarticular transplantation of single dose 3 to 5 ml normal saline as placebo
-
Category
-
Placebo
1
-
Sponsor
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Royan Institute
-
Proportion provided by this source
-
90
-
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
-
-
Grant name
-
-
Grant code / Reference number
-
-
Is the source of funding the same sponsor organization/entity?
-
Yes
-
Title of funding source
-
Shafa Yahyaeian Hospital
-
Proportion provided by this source
-
10
-
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
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
-
Not applicable
-
Informed Consent Form
-
Undecided - It is not yet known if there will be a plan to make this available
-
Clinical Study Report
-
Not applicable
-
Analytic Code
-
Not applicable
-
Data Dictionary
-
Not applicable