In this randomized controlled trial, 30 human subjects with grade 2 and 3 knee osteoarthritis (according to plain radiography) will be enrolled according to inclusion and exclusion criteria. Patients will be randomly distributed into 2 groups of 15 patients. The initial MRI will be performed for all patients and the patients will be treated as follow: 1) intra-articular injection of bone marrow derived mesenchymal cells or MSCs (treatment group) 2) intra-articular injection of commercially available hyaluronic acid gel (control group). Patients’ follow-ups will be at month 1, 3, 6 and 12 post-treatment. At each follow-up, a clinical examination including range of motion and crepitus of the knee as well as an assessment of patient's health with KOOS (Knee injury and Osteoarthritis Outcome Score) questionnaire and NRS (Numerical Rating Scale) will be performed. Another MRI (second MRI) and a plain standing radiograph of the knee (second radiograph) will be done at 6th month post-injection and the results will be read according to modified MOCART (Magnetic Resonance Observation of Cartilage Repair Tissue) and K&L (Kellgren and Lawrence) scales. Following the last follow-up, the collected data will be compared and analyzed in a way that firstly, the findings of each patient in each group before and after the intervention will be independently compared, and secondly, the results of each group will be compared with the other group.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016021710507N4
Registration date:2016-02-20, 1394/12/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-02-20, 1394/12/01
Registrant information
Name
Zhaleh Shariati Sarabi
Name of organization / entity
Department of Internal Medicicince, Imam Reza Hospital
Country
Iran (Islamic Republic of)
Phone
+98 51 1802 2370
Email address
shariatij@mums.ac.ir
Recruitment status
Recruitment complete
Funding source
Mashhad University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2016-09-23, 1395/07/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Effectiveness of Intra-Articular Injection of Bone Marrow Derived Stem Cells for Treatment of Degenerative Knee Osteoarthritis
Public title
Evaluation of Effectiveness of Intra-Articular Injection of Stem Cells on Knee Arthrosis
Purpose
Treatment
Inclusion/Exclusion criteria
INCLUSION CRITERIA: Female or male patient with knee osteoarthritis based on the ACR criteria and knee radiography; Grade 2 or 3 osteoarthritis according to Kellgren and Lawrence grading scale; 45 < Patient’s Age< 75; Signed informed consent; No consumption of glucocorticoids, anti-inflammatory and immunomodulatory medications one week prior to the treatment; No history of previous participating in clinical trials on treatment of osteoarthritis; No intra-articular injection of hyaluronic acid in the past 6 months EXCLUSION CRITERIA: Secondary osteoarthritis; Concurrent connective tissue disorder; Active neurological disease; Severe cardiac disease; Debilitating respiratory disease requiring constant treatment; Any endocrinopathy; Malignancies; Current infectious disease; Psychologic diseases (especially major depression) requiring treatment with antidepressants or related medications; Being under treatment with immunosuppressive or cytotoxic medications; Being under constant treatment with antithrombotic medications; History of allergy to biologic products; Hb < 11 g/dL; Plt < 120*103/μL
Age
From 45 years old to 75 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
30
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
Mashhad University of Medical Sciences
Street address
Daneshgah St.
City
Mashhad
Postal code
913791-3316
Approval date
2015-02-06, 1393/11/17
Ethics committee reference number
511/4436
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
Primary outcomes
1
Description
Morphological characteristics of of articular cartilage
Timepoint
Before intervention, 6 months post-intervention, 12 months post-intervention
Method of measurement
Modified version of "Magnetic Resonance Observation of Cartilage Repair Tissue" (Modified MOCART)