Protocol summary
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Study aim
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The effects of Autologous Conditioned Serum therapy on chronic knee osteoarthritis
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Design
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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.
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Settings and conduct
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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 and 6 months after the first injection, the cases mentioned above will be recorded.
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Participants/Inclusion and exclusion criteria
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A total of 15 patients were selected based on radiologic findings with a period of three-month symptoms of knee osteoarthritis.
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Intervention groups
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ACS treatment group; control group without any treatment
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Main outcome variables
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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
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Reason for update
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Acronym
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OA
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IRCT registration information
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IRCT registration number:
IRCT20160422027520N13
Registration date:
2019-08-14, 1398/05/23
Registration timing:
prospective
Last update:
2019-12-22, 1398/10/01
Update count:
1
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Registration date
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2019-08-14, 1398/05/23
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2019-08-23, 1398/06/01
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Expected recruitment end date
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2020-03-19, 1398/12/29
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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The effects of Autologous Conditioned Serum therapy on chronic knee osteoarthritis
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Public title
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Treatment of chronic knee osteoarthritis with Autologous Conditioned Serum
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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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)
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Age
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From 18 years old to 75 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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Sample size
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Target sample size:
15
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Randomization (investigator's opinion)
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Not randomized
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Randomization description
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Blinding (investigator's opinion)
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Single blinded
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Blinding description
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The study participants were unaware of their placement in the study group (Autologous Conditioned Serum or normal saline).
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Ethics committees
1
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Ethics committee
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Approval date
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2019-07-15, 1398/04/24
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Ethics committee reference number
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IR.TBZMED.REC.1398.466
Health conditions studied
1
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Description of health condition studied
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Osteoarthritis
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ICD-10 code
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M15.4
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ICD-10 code description
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Erosive (osteo)arthritis
Primary outcomes
1
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Description
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Determining knee pain by VAS in all phases of clinical trial
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Questionnaire (VAS)
2
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Description
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Determination of knee function by WOMAC and KOOS in all phases of clinical trial
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Questionnaire (WOMAC), Questionnaire (KOOS)
3
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Description
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Determine the range of knee motion by manual joiniometry in all phases of clinical trial
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Timepoint
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Before injection and 1, 3 and 6 months after the first injection
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Method of measurement
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Range of motion (Degree)
Intervention groups
1
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Description
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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 and 6 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.
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Category
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Treatment - Other
2
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Description
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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 and 6 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.
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Category
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Treatment - Other
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Pishtaz teb zaman Co.
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Proportion provided by this source
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100
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Public or private sector
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Private
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available