Effect of platelet lysate on chronic knee osteoarthritis
Design
40 patients were selected based on radiologic findings with a period of 3 months symptoms of knee osteoarthritis and classified into two groups of PL and control group without any treatment. For the preparation of PL, 20 ml of blood from the upper cubital vein will be taken and, after production of PRP and, in order to produce PL, it is frozen at -80 ° C for 60 minutes, and then at 37°C Melt for 15 minutes. Then, centrifuge the platelets and WBC to remove the membranes and filter with 0.22 micrometers.
Settings and conduct
The following items for the patients who are most relevant, recorded:
1) Pain by visual analog scale (VAS)
2) Knee function by the WOMAC
3) Knee function by KOOS
4)The thickness of the knee cartilage using MRI
After PL and quality control, patients will be referred to the Rehabilitation and Physical Medicine Department of the Shahid Madani Hospital for the injection of PL in the knee. An injection of PL into patients will be done by supralateral method, in which the patient will rest on the back and the knee will almost completely open. A second injection is repeated at intervals of 21 days. Then, in order to evaluate the effect of PL on patients in the intervals of 1, 3, 6 and 12 months after the first injection, the cases mentioned above will be recorded.
Participants/Inclusion and exclusion criteria
A total of 40 patients were selected based on radiologic findings with a period of three-month symptoms of knee osteoarthritis.
Intervention groups
PL treatment group
Control group without any treatment
Main outcome variables
1- Determining knee pain by VAS in all phases of clinical trial
2-Determination of knee function by WOMAC and KOOS in all phases of clinical trial
3-Determine the range of knee motion by manual joiniometry in all phases of the trial
4-Measuring Growth Factors in Platelet Lysates
General information
Reason for update
Acronym
OA
IRCT registration information
IRCT registration number:IRCT20160422027520N10
Registration date:2019-02-27, 1397/12/08
Registration timing:registered_while_recruiting
Last update:2019-02-27, 1397/12/08
Update count:1
Registration date
2019-02-27, 1397/12/08
Registrant information
Name
Mehdi Yousefi
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Country
Iran (Islamic Republic of)
Phone
+98 41 3336 4665
Email address
yousefime@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2019-02-09, 1397/11/20
Expected recruitment end date
2019-12-21, 1398/09/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of platelet lysate therapy on chronic knee osteoarthritis
Public title
Treatment of chronic knee osteoarthritis with platelet lysis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Men and women between the ages of 18 and 75 with OA diagnosis based on the American College of Rheumatology
Analog scale of knee pain (VAS) equal to or greater than 2.5
People with at least 4 months of history of pain or swelling in one or both knees
Radiological classification scale Kellgren-Lawrence 1 or 2
The availability of individual during the study period
BMI Between 20 and 35
Exclusion criteria:
People under the age of 18 and over 75 years
Pregnant women or women who are breastfeeding
People with malignancy,People with severe heart disease, uncontrolled diabetes mellitus, rheumatoid arthritis, hemorrhagic diseases, history of anemia, arthritis, fibromyalgia and chronic fatigue syndrome
Those linked to acetaminophen or Vicodin or a history of drug misuse
History of cortisone injections in the last 6 weeks
The use of non-steroidal anti-inflammatory drugs 1 week ago
Having hemoglobin less than 11 g / dl and platelet count less than 150000 / mμ
The use of inhibitors of platelet aggregation and anti-coagulation such as heparin
History of knee surgery in the last 3 months
Extraordinary deformation (varus >5ᵒ, valgus >5ᵒ)
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences , Daneshghah st, Tabriz,
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Approval date
2019-02-04, 1397/11/15
Ethics committee reference number
IR.TBZMED.REC.1397.923
Health conditions studied
1
Description of health condition studied
Osteoarthritis
ICD-10 code
M15.4
ICD-10 code description
Erosive (osteo)arthritis
Primary outcomes
1
Description
Determining knee pain by VAS in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Questionnaire (VAS)
2
Description
Determination of knee function by WOMAC and KOOS in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Questionnaire (WOMAC), Questionnaire (KOOS)
3
Description
Determine the range of knee motion by manual joiniometry in all phases of clinical trial
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Range of motion (Degree)
4
Description
Measurement of growth factors in platelet lysate
Timepoint
1, 3, 6 and 12 months after the first injection
Method of measurement
Elisa
Secondary outcomes
1
Description
Determine the thickness of the knee cartilage
Timepoint
12 months after the first injection
Method of measurement
MRI
Intervention groups
1
Description
Intervention group: Patients with knee arthritis receiving platelet lysate
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Madani Hospital, Tabriz
Full name of responsible person
Mehdi Yousefi, Ph.D Of Medical Immunology
Street address
Shahid Madani Hospital, Golbad Avenue, Tabriz
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 7767
Email
mehdi_yusefi@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Seyed Kazem Shakouri
Street address
Tabriz University of Medical Seciences
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3335 5921
Email
mehdi_yusefi@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
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
Person responsible for general inquiries
Contact
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Immunology, Faculty of Medicine, Tabriz University of Medical Sciences, Tabriz, Iran
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Mehdi Yousefi
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Immunology
Street address
Tabriz University of Medical Sciences, Golgasht Avenue,Tabriz, Iran
City
Tabriz
Province
East Azarbaijan
Postal code
5166614766
Phone
+98 41 3336 4665
Fax
+98 41 3336 4665
Email
yousefime@tbzmed.ac.ir
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
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available