The effects of intra-articular injection of mesenchymal stem cells on improvement of pain and physical function in patients with knee joint osteoarthritis -An interventional double blind randomized clinical trial phase II
Study Objects: Osteoarthritis is a degenerative disease of the joint cartilage, which often affects the subchondral bone. In this study, the effects of intra articular injection of bone marrow derived autologous mesenchymal stem cells on pain relief and physical function of moderate to severe knee osteoarthritis will be evaluated.
Study design and method: In a double blind randomized placebo-controlled phase II study, 48 patients with chronic knee osteoarthritis who visited in orthopedics clinic of Shahid Madani hospital and Royan cell therapy center, would be assessed through two groups including the case group (20 millions autologous mesenchymal stem cells in two doses) and the placebo group.
Participants: Patients in a range of 18 to 65 years old who have been diagnosed to have osteoarthritis through MRI, and are not suffered from other chronic diseases and cancer, would be studied.
Interventions:
Intraarticular transplantation of 20 millions of mesenchymal stem cells in two doses in the case group; placebo injection in the control group
Outcome variables: It would be tried to reduce the pain and improve the physical function of the patients and increase the damaged cartilage thickness through intraarticular transplantation of autologous bone marrow derived mesenchymal stem cells. The follow ups would be included: Radiographic findings, VAS (Visual Analogue Scale), WOMAC (Western Ontario and McMaster Universities Osteoarthritis index-pain, physical function and stiffness sub scores) questionnaire, MRI and Walking Distance (WD).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201507061031N1
Registration date:2016-06-30, 1395/04/10
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-06-30, 1395/04/10
Registrant information
Name
Nasser Aghdami
Name of organization / entity
Royan Institute
Country
Iran (Islamic Republic of)
Phone
+98 21 2356 2000
Email address
nasser.aghdami@royaninstitute.org
Recruitment status
Recruitment complete
Funding source
Department of Regenerative Biomedicine, Cell Science Research Center, Royan Institute for Stem Cell Biology and Technology
Expected recruitment start date
2012-12-25, 1391/10/05
Expected recruitment end date
2015-10-31, 1394/08/09
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of intra-articular injection of mesenchymal stem cells on improvement of pain and physical function in patients with knee joint osteoarthritis -An interventional double blind randomized clinical trial phase II
Public title
Transplantation of stem cells 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 neurologic disorder; End organ damage; History/active malignancy; Uncontrolled endocrine disorder; Active respiratory disorder/reaction to sedation drugs; History of cancer
Age
From 18 years old to 65 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
blocking
Secondary Ids
1
Registry name
ClinicalTrials.gov
Secondary trial Id
NCT01504464
Registration date
2012-01-03, 1390/10/13
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Royan infertility institute
Street address
Royan institute, Eastern Hafez St,Northern Banihashem St, 45 m Resalat highway
City
Tehran
Postal code
Approval date
2011-07-12, 1390/04/21
Ethics committee reference number
EC/90/1026
Health conditions studied
1
Description of health condition studied
Knee joint osteoarthritis
ICD-10 code
M17.0
ICD-10 code description
Primary gonarthrosis, bilateral
2
Description of health condition studied
Knee joint osteoarthritis
ICD-10 code
M17.1
ICD-10 code description
Other primary gonarthrosis Primary gonarthrosis: • NOS • unilateral
Primary outcomes
1
Description
Function improvement
Timepoint
3,6,12 and 30 months after transplantation
Method of measurement
WOMAC osteoarthritis index
2
Description
Pain density
Timepoint
3,6,12 and 30 months after transplantation
Method of measurement
Visual Analogue Scale
Secondary outcomes
1
Description
Cartilage thickness
Timepoint
6,12 and 30 months after transplantation
Method of measurement
MRI
2
Description
Subchondral edema
Timepoint
6,12 and 30 months after transplantation
Method of measurement
MRI
3
Description
Joint function
Timepoint
6,12 and 30 months after transplantation
Method of measurement
Physical examination, VAS, womac
4
Description
Allergic reactions
Timepoint
3,6,12and 30 month after transplantation
Method of measurement
Physical examination
5
Description
Neoplastic changes
Timepoint
6,12 and 30 months after transplantation
Method of measurement
MRI
Intervention groups
1
Description
Case group: Biological: Intraarticular transplantation of 20 millions autologous bone marrow mesenchymal stem cells in 3 to 5 ml N/S in two doses which will be injected in 0 and 12 months.
Category
Treatment - Other
2
Description
Control group: Biological: Placebo Patients with knee joint osteoarthritis who underwent intra articular placebo injection