Evaluation of the injection of umbilical cord-derived stem cells and platelet-rich plasma in patients with resistant lateral epicondylitis in patients referred to the super-specialized orthopedic clinic of Imam Khomeini Hospital in Sari
Evaluation of the injection of umbilical cord-derived stem cells and platelet-rich plasma in patients with resistant lateral epicondylitis
Design
Clinical trial with a control group, with parallel groups, No blinding, randomized, phase 3 on 24 patients. rand function of excel software was used for randomization.
Settings and conduct
Patients suffering from lateral epicondylitis are selected from those who refer to Imam Hospital, Sari, Iran. In this way, all the patients who enter, provided they meet the entry criteria and do not have the exit criteria and complete the consent form until the required number of the study is filled, are accepted and entered the study without exception.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 20 to 60 years with elbow pain and limitation of motion that have lasted for more than 3 months and did not respond to non-surgical treatment and corticosteroid injection for 6 to 12 months as a chronic and treatment-resistant type It is considered, lack of response to drug treatment and physiotherapy, recurrence of the disease. Conditions of non-entry: patients with a history of elbow arthritis and a history of elbow fracture, patients with a history of elbow surgery, patients with systemic blood problems
Intervention groups
Intervention groups: 1- umbilical cord-derived stem cells 2- Platelets rich in plasma 3- Platelets rich in plasma and umbilical cord-derived stem cells and control group
Main outcome variables
Pain level; grip strength; range of motion
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231206060276N1
Registration date:2024-05-20, 1403/02/31
Registration timing:retrospective
Last update:2024-05-20, 1403/02/31
Update count:0
Registration date
2024-05-20, 1403/02/31
Registrant information
Name
sara hosseini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3336 1700
Email address
sarahosseinirahimi1993@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-04-16, 1403/01/28
Expected recruitment end date
2024-05-17, 1403/02/28
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the injection of umbilical cord-derived stem cells and platelet-rich plasma in patients with resistant lateral epicondylitis in patients referred to the super-specialized orthopedic clinic of Imam Khomeini Hospital in Sari
Public title
Evaluation of the injection of umbilical cord-derived stem cells and platelet-rich plasma in patients with resistant lateral epicondylitis in patients referred to the super-specialized orthopedic clinic of Imam Khomeini Hospital in Sari
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients in the age group of 20 to 60 years with pain and limitation of elbow movement, whose symptoms have been present for more than 3 months and did not respond to non-surgical treatment and corticosteroid injection for 6 to 12 months.
It is considered as a chronic type and resistant to treatment.
Failure to respond to drug and physiotherapy treatment
Recurrence of the disease
Exclusion criteria:
Patients with a history of elbow arthritis and a history of elbow fracture
Patients who have a history of elbow surgery
Patients with systemic blood problems
Age
From 20 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
24
Randomization (investigator's opinion)
Randomized
Randomization description
This randomized controlled trial (RCT) study is a type of factorial design. In its simplest form, the factorial design tries to evaluate two interventions compared to the control (control group) in a single trial, including 4 groups:
Group 1: 6 people who were approved to enter the study with the approval and examination of a specialist doctor and were treated with lateral epicondyle PRP injection.
Group 2: 6 people who were approved to enter the study with the approval and examination of a specialist doctor and were treated with the injection of umbilical cord-derived stem cells to the lateral epicondyle.
Group 3: 6 people who were approved to enter the study with the approval and examination of a specialist doctor and were treated with the injection of umbilical cord-derived stem cells and PRP to the lateral epicondyle.
Group 4: 6 people who were approved to enter the study with the approval and examination of a specialist doctor, and these patients are not given any injections and are only treated with oral anti-inflammatory drugs.
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
Imam (RA) Sari Educational and Medical Hospital - Mazandaran University of Medical Sciences (Researc
Street address
Amir Mazandarani Blvd. Imam Khomeini Medical Education Center
City
Sari
Province
Mazandaran
Postal code
IR.MAZUMS.IMAMHOSPIT
Approval date
2023-06-07, 1402/03/17
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1402.086
Health conditions studied
1
Description of health condition studied
Medial epicondylitis
ICD-10 code
M77.0
ICD-10 code description
Medial epicondylitis
Primary outcomes
1
Description
GRIP Score
Timepoint
The fourth week, the eighth week, the third month, and the sixth month
Method of measurement
dynamometer
2
Description
The amount of pain
Timepoint
The fourth week, the eighth week, the third month, and the sixth month
Method of measurement
Visual Analogue Scale
3
Description
Range of motion
Timepoint
The fourth week, the eighth week, the third month, and the sixth month
Method of measurement
Patient Rated Tennis Elboow Evaluation
Secondary outcomes
1
Description
Quality of life score - pain reduction score
Timepoint
It is evaluated at different intervals of the fourth week, the eighth week, the third month, and the sixth month
Method of measurement
Dynamometer and questionnaire
Intervention groups
1
Description
Group 1: In the group where PRP injection is performed, the amount of injection is 2 cc. In order to prepare platelet-rich plasma, the blood sample is poured into a tube containing the anticoagulant dextrose citrate, and the sample is centrifuged using a two-stage centrifugation method or the double spin method. The whole blood is centrifuged at 250 g for 10 minutes at a constant speed to form three different layers. It is white blood and the upper layer contains platelets dissolved in plasma. Then, the upper layer and the woven layer are removed and placed in the second centrifuge at 1000 g for 10 minutes, which leads to pelleted platelets. The pellet is dissolved again in plasma to reach a volume of 1 to 3 cc
Category
Treatment - Other
2
Description
Group 2: In the group that is a candidate for PRP injection and stem cells derived from the umbilical cord, 1 cc of PRP and 1 cc of suspension of stem cells derived from the umbilical cord are combined and then injected into the place of maximum pain in the elbow.
Category
Treatment - Other
3
Description
Group 3: In the group where stem cells derived from the umbilical cord are injected, the amount of injection is 2 cc, which is kept in normal saline solution. Stem cells derived from the umbilical cord of a newborn are prepared from a newborn baby And it is not from the umbilical cord bank. Isolation of mesenchymal stem cells from Wharton jelly of human umbilical cord: a umbilical cord sample will be transferred from the hospital to the clean room of the laboratory in the physiological serum along with receiving consent from the patient. Then, for disinfection, it is placed in 70% alcohol for 30 seconds and transferred under the hood to the container containing the transfer medium. The umbilical cord is cut into two-centimeter pieces and placed in a Petri dish containing Hanks balanced salt solution (HBSS). The epithelium of the umbilical cord is cut and slowly the vessels are separated from the umbilical cord. The pieces of Wharton's jelly are gently removed and transferred to the HBSS dish. Wharton jelly pieces are cut into small pieces with a scalpel. The pieces will be cultured in a T25 flask containing DMEM (GIBCO, UK) (Dulbecco's Modified Eagle's Medium) and FBS (fetal bovine serum) (SIGMA-Aldrich) 15%, 1% antibiotic (penicillin/streptomycin). The flask is transferred to the incubator with a temperature of 37 degrees and humidity of 95% and CO2 of 5% and after 3 days the culture medium of the flask is changed.
Category
Treatment - Other
4
Description
Control group: In this group, no injections are given and they are only treated with oral anti-inflammatory drugs
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini Medical Education Center of Sari
Full name of responsible person
Mehran Razavipour
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
m.razavipour@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid Saeedi
Street address
Mazandaran University of Medical Sciences, Valiasr Blvd.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3335 2725
Fax
+98 11 3335 2725
Email
majsaeedi@gmail.com
Web page address
https://www.mazums.ac.ir/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran 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
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Razavipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
m.razavipour@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Razavipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
m.razavipour@mazums.ac.ir
Web page address
https://www.mazums.ac.ir/
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Mehran Razavipour
Position
Associate Professor
Latest degree
Specialist
Other areas of specialty/work
Orthopedics
Street address
Amir Mazandarani Blvd
City
Sari
Province
Mazandaran
Postal code
33131 - 48166
Phone
+98 11 3336 1700
Fax
+98 11 3336 1700
Email
m.razavipour@mazums.ac.ir
Web page address
https://www.mazums.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