Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II
• Determining the safety of intra-articular injection of three consecutive doses of platelet-rich plasma derived from non-autologous umbilical cord blood in patients with knee osteoarthritis
Design
Randomised controlled trial, with parallel groups, double-blind, phase 1/2 on 30 patients, randomized using Random allocation software
Settings and conduct
Patients are injected 3 times at intervals of 0, 2 and 4 months in the operating room of Royan Clinic. Patients will be monitored for up to one year. For the purpose of blinding, the biological product will be prepared in the form of disposable 5 cc syringes that look exactly like each other with a special label. Only the doctor and the person in charge of the transplant will know the type of treatment received.
Participants/Inclusion and exclusion criteria
Inclusion criteria: age range 45-70, years of knee osteoarthritis with grade 2 and 3 MRI diagnosis, knee pain ≥4, completion of informed consent form Exclusion criteria: pregnant, lactating women or disabled adults, intrachondral injection within the last 2 months, Abnormal hematological or biochemical tests, History of any type of neoplasm, Aspirin consumption one week before cell injection, History of coagulopathy or use of anticoagulant drugs, Positive viral tests, Rheumatoid arthritis or other autoimmune diseases involving joints, History of corticosteroid use in 3 last month
Intervention groups
Control group: patients receiving 3 doses of PRP. Test group: patients receiving 3 doses of hyaluronic acid
Main outcome variables
Adverse events (AEs) and severe adverse events (SAEs), WOMAC, VAS, SF-36, Articular cartilage thickness
General information
Reason for update
Acronym
PRP : Platelet Rich Plasma
IRCT registration information
IRCT registration number:IRCT20211102052944N2
Registration date:2023-02-09, 1401/11/20
Registration timing:prospective
Last update:2023-02-09, 1401/11/20
Update count:1
Registration date
2023-02-09, 1401/11/20
Registrant information
Name
Elaheh Afzal
Name of organization / entity
Royan stem cell technology company
Country
Iran (Islamic Republic of)
Phone
+98 21 2763 5735
Email address
e.afzal@rsct.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-04-21, 1402/02/01
Expected recruitment end date
2023-08-23, 1402/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Safety and efficacy evaluation of intra-articular knee transplantation of three consecutive doses of Platelet-Rich Plasma in patients with knee osteoarthritis: Interventional clinical trial, Phase II
Public title
Effect of PRP derived from umbilical cord blood in the treatment of knee arthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
45-70 years
Kellgren and Lawrence grade of both knees between 2 and 3
knee pain for at least 4 months that has not responded to common medical and physical therapies.
Visual analogue score ≥ 4
Informed consent
Exclusion criteria:
Pregnancy or lactation
Presence of any concomitant knee injury that causes pain or swelling (eg, ligament damage or meniscal tear)
Intra-articular injection of hyalgan or steroid drugs during the last 2 months
Malalignment of the knee joint more than 15 degrees (diagnosis with triple joint view radiography)
Documented uncontrolled underlying diseases (including diabetes (HbA1c ≥ 8), heart failure (EF<45%), kidney failure (Cr>2), liver failure (AST, ALT>100)
The existence of blood or cardiovascular diseases, infections and weak immunity, neoplasm, etc., which interfere with the evaluations.
History of orthopedic surgery in the spine or lower limbs
osteoarthritis of the hip or ankle joint
Known allergy to hyaluronic acid products
Taking aspirin one week before cell injection
History of coagulopathy or use of anticoagulant drugs
Age
From 45 years old to 70 years old
Gender
Both
Phase
2
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Sample size
Target sample size:
30
Randomization (investigator's opinion)
Randomized
Randomization description
Patients will be randomly assigned to the control and MSC groups. The method of random assignment of these two groups is block randomization. The size of the blocks is 6 people and using Random allocation software, the sequence of assigning patients to the groups is determined, and this sequence will be kept by the transplant manager.
Blinding (investigator's opinion)
Double blinded
Blinding description
This study is a double-blind study. Patients and study analysts will be unaware of the type of treatment assigned. To achieve this goal, by using a biological product in the form of disposable 5 cc syringes that are already filled by the nurse and are completely "similar" to the type of treatment received, to blind the participants in the study. Also, the people who apply the treatment will be different from the people who are responsible for examining and evaluating the patients, and the biological product packages will be labeled according to a specific code. Only the doctor and the person in charge of the transplant will know the type of treatment the patients receive.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
پژوهشگاه رویان - جهاد دانشگاهی (کمیته اخلاق در پژوهش)
Street address
Tehran, Resalat Highway, North Bani Hashem St., Hafez Koi, Royan Research Institute, Vice President of Research, Secretariat of Ethics Committee in Research of Royan Research Institute
City
Tehran
Province
Tehran
Postal code
148- 16635
Approval date
2023-01-29, 1401/11/09
Ethics committee reference number
IR.ACECR.ROYAN.REC.1401.110
Health conditions studied
1
Description of health condition studied
Knee Osteoarthritis
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Adverse events and severe adverse events
Timepoint
2, 4, 6, 9, and 12 months after intervention
Method of measurement
Clinical signs and questionnaire
2
Description
Western Ontario and McMaster Universities Osteoarthritis Index
Timepoint
Baseline and 2, 4, 6, 9, and 12 months after intervention
Method of measurement
WOMAC Questionnaire
3
Description
Visual analog scale
Timepoint
Baseline and 2, 4, 6, 9, and 12 months after intervention
Method of measurement
Visual Analogue Scale Questionnaire
4
Description
Disability index
Timepoint
Baseline and 6, 9, and 12 months after intervention
Method of measurement
Short Form Health-36 Questionnaire
5
Description
Articular cartilage thickness
Timepoint
Baseline and 12 months after intervention
Method of measurement
Magnetic resonance imaging
Secondary outcomes
1
Description
Adverse events and severe adverse events
Timepoint
2, 4, 6, 9, and 12 months after intervention
Method of measurement
Clinical signs and questionnaire
Intervention groups
1
Description
Control group: Patients receiving 3 doses of normal saline + Hyaluronic acid The procedure will be performed in such a way that patients are injected intra-articular injection of 2 cc of hyaluronic acid in three times at 0,1 and 2 months intervals in the operating room of Royan Clinic. At the time of injection, the patient's knee is sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient is monitored for 2 hours and after this period, if there is no problem with the necessary medication and care instructions and explanation of warning signs will be discharged.
Category
Treatment - Drugs
2
Description
Intervention group: Intervention group: patients receiving 3 doses of PRP. The procedure of the intervention will be that the patients will be injected with 5 cc of PRP derived from non-autologous umbilical cord blood in the operating room of Royan Clinic on three occasions with intervals of 0, 1 and 2 months. . On the day of the knee transplant, the patient's knee will be sterilized and the orthopedic surgeon will inject into the joint space under sterile conditions. After the injection, the patient will be observed for 2 hours and after this period, if no problem occurs, he will be discharged with the necessary medication and care instructions and an explanation of the warning signs.
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
The information and data will be published as an article after reviewing and verifying them. All data is potentially shareable after unidentified individuals.
When the data will become available and for how long
After following the patients and collecting data, checking the safety and efficiency of cell injection and then writing the article, which is done about 3 months after the follow-up, the data file will be published.
To whom data/document is available
Access to the documents of this research is not limited to academic and scientific researchers, and specialists working in other centers can also access these documents.
Under which criteria data/document could be used
Designing similar studies in other academic centers
From where data/document is obtainable
e.afzal@rsct.it
What processes are involved for a request to access data/document
Within 1-2 months after application. Applicants for access to the research documents must provide evidence of their activity in the relevant field and their need for this data along with their application email.