The study is designed as a double blind clinical trial,in which neither the subject nor the person administering the treatment nor the person evaluating the response to treatment knows which treatment any particular subject is receiving.20 patients of knee osteoarthritis based on inclusion and exclusion criteria will join the study. After primary evaluations including VAS, KOOS questionnaire, clinical examination and MRA (magnetic resonance arthrography) they will be randomized by sealed envelope methode in 2 case and control groups .10 patients in Case group will receive 30 million allogenic adipose-derived mesenchymal stem cells from young healthy donors which collected and prepared in standard conditions, in a single intraarthicular injection while the control group will receive intraarthicular injection of PBS (Phosphate Buffered Saline) in a sterile setting. Evaluations after the injection are clinical signs of inflammation till 30 minutes after injection, VAS, KOOS questionnaire and clinical examination at 2 weeks, 2 months and 6 months and paraclinical (MRA) at 6 months after injection.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021123298N3
Registration date:2016-02-20, 1394/12/01
Registration timing:prospective
Last update:
Update count:0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Mohamad Vasei
Name of organization / entity
Tehran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8490 2187
Email address
mvasei@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Iran University Of Medical Science
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2016-06-20, 1395/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect And Safety Of Allogenic Adipose-Derived Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis, Pilot Study
Public title
Mesenchymal Stem Cells In Treatment Of Knee Osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: knee osteoarthritis based on ACR (American College of Rheumatology) criteria and grade 1,2,3 based on Kellgren-Lawrence grading scale; Ability to follow during the study period exclusion criteria: age <18 and >75 years; presence of any acute or chronic infectious process; knee deformity (varus >10 ° or valgus >20° ); impaired renal function(creatinine>2.0 mg/dl); impaired liver function(Bilirubin > 2.0 ㎎/㎗, AST/ALT > 100 IU/L); Pregnancy or lactating; neoplasia; BMI>35; Immunosuppressive state; Systemic autoimmune rheumatic disease or secondary osteoarthritis; intraarthicular injections in last 3 months; history of knee surgery; Poorly controlled diabetes mellitus
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:
20
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Iran University of Medical Science
Street address
Medical faculty, Iran University of Medical Sience, Hemmat High way,Tehran
City
Tehran
Postal code
Approval date
2016-01-24, 1394/11/04
Ethics committee reference number
IR.IUMS.REC.1394.26914
Health conditions studied
1
Description of health condition studied
osteoarthritis
ICD-10 code
M19.0
ICD-10 code description
Primary arthrosis NOS
Primary outcomes
1
Description
KOOS value
Timepoint
before,2 weeks,2 months and 6 months after injection
Method of measurement
KOOS questionnaire
2
Description
VAS value
Timepoint
before,2 weeks,2 months and 6 months after injection
Method of measurement
VAS
3
Description
knee range of motion
Timepoint
before,2 weeks,2 months and 6 months after injection
Method of measurement
goniometer
4
Description
radiologic MRA parameters
Timepoint
before and 6 months after injection
Method of measurement
MRA(magnetic resonance arthrography)
Secondary outcomes
1
Description
clinical sign and symptoms of inflammatory and allergic reactions
Timepoint
before,30 minute,2 weeks,2 months and 6 month after injection