The effects of Autologous Conditioned Serum therapy on chronic knee osteoarthritis
Design
Fifteen patients were selected based on radiologic findings randomly with the period of three months of knee osteoarthritis are classified. Patients were randomly assigned to receive 10 cc of blood from a cobital vein injection and collected in an ACS syringe manufactured by Pishtaz teb zaman Co. and used to produce ACS. For this purpose, blood in the syringe is incubated for 24 hours at 37 ° C to release growth and anti-inflammatory factors,The blood is then centrifuged at 3000 g for 10 minutes to remove the ACS. After separation, the ACS is filtered with a 0.22 μm filter and stored at -80 ° C until use.
Settings and conduct
The following items for the patients who are most relevant, recorded: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). After producing ACS and quality control, patients will be referred to the Rehabilitation and Physical Medicine Department of the Shahid Madani Hospital for the injection of ACS by supralateral in the knee. A second injection is repeated at intervals of 21 days. Then, in order to evaluate the effect of ACS 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 15 patients were selected based on radiologic findings with a period of three-month symptoms of knee osteoarthritis.
Intervention groups
ACS 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
General information
Reason for update
Acronym
OA
IRCT registration information
IRCT registration number:IRCT20160422027520N13
Registration date:2019-08-14, 1398/05/23
Registration timing:prospective
Last update:2019-08-14, 1398/05/23
Update count:1
Registration date
2019-08-14, 1398/05/23
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
2019-08-23, 1398/06/01
Expected recruitment end date
2020-03-19, 1398/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effects of Autologous Conditioned Serum therapy on chronic knee osteoarthritis
Public title
Treatment of chronic knee osteoarthritis with Autologous Conditioned Serum
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
2
Groups that have been masked
Participant
Sample size
Target sample size:
15
Randomization (investigator's opinion)
Not randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
The study participants were unaware of their placement in the study group (Autologous Conditioned Serum or normal saline).
Placebo
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
2019-07-15, 1398/04/24
Ethics committee reference number
IR.TBZMED.REC.1398.466
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
Before injection and 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
Before injection and 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
Before injection and 1, 3, 6 and 12 months after the first injection
Method of measurement
Range of motion (Degree)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: Fifteen patients with knee osteoarthritis receive Autologous Conditioned Serum as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). In this group of patients, 10 ml of blood was taken by ACS-specific syringe manufactured by Pishtaz teb zaman CO. and after incubation of this syringe according to protocol kit, we separate the ACS. The ACS is then injected by a physician into one of the two knees of the patient with knee osteoarthritis. The injection volume of ACS is 2 cc.Repeat injections twice again 21 days apart.Then, in order to evaluate the effect of ACS on patients in the intervals and Compare it with another patient's knees who received normal saline, 1, 3, 6 and 12 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded.
Category
Treatment - Other
2
Description
Control group: Fifteen patients with knee osteoarthritis receive normal saline (NS) as the intervention group. Initially, receive informed consent from the patients and the following will be recorded for these patients who meet the inclusion criteria: 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM). Then NS by the physician is injected into another patient's knee. Repeat injections twice again 21 days apart. Then, in order to evaluate the effect of NS on patients in the intervals and Compare it with another patient's knees who received ACS, at 1, 3, 6 and 12 months after the first injection, 1) Pain by VAS 2) Knee function by WOMAC 3) Knee function by KOOS 4) Flexion range of motion (ROM) will be recorded.
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
Pishtaz teb zaman Co.
Full name of responsible person
Behrooz Hajeian tehrani
Street address
Golha, Pishtaz teb zaman Co.
City
tehran
Province
Tehran
Postal code
1494734463
Phone
+98 21 4219 7000
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
Pishtaz teb zaman Co.
Proportion provided by this source
100
Public or private sector
Private
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
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
Person responsible for scientific inquiries
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
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