Determination of therapeutic effect of injection under the guidance of adipose
mesenchymal cell sonography with control group in patients with knee osteoarthritis
Design
Clinical trial including control group and factorial groups, and in two-way blind, will randomly perform. This study carry out in phase 3 with 80 patients.
Settings and conduct
Adipose tissue from the superficial layer of the abdomen will be removed during liposuction from 25 to 35 years old with personal consent. This surgery is performed in Hazrat Rasoul Akram Hospital (Iran, Tehran). Stem cells are separated from fat according to the protocol and injected into intervention groups.
The collected data for each patient are recorded in the patient profile and finally statistical analysis of the data will be performed using SPSS 20 software.
Participants/Inclusion and exclusion criteria
Input criteria include the following:
1. Knee osteoarthritis based on the American College of Rheumatology criteria, in Grade 1,2,3 corresponds to the Lawrence and Kellgren criteria.
2. Knee pain for at least six months
And inclusion criteria are included
Absence of inflammatory inflammatory diseases of the joint or secondary osteoarthritis
2. Absence of local or systemic infectious process
3. Do not perform intra-articular injections during the last trimester
4. No history of knee surgery
Intervention groups
80 people are selected with the mentioned entry and non-entry conditions. Individuals are divided into 20 blocks of 4. in each group 1 person is selected randomly as control group. and 3 people of each block are randomly selected for fat-derived stem cell injection.
Main outcome variables
Cartilage thickness as measured using MRI results; Pain assessed using the VAS test; The range of motion of flexion and extension of the knee is assessed using a goniometric test.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210307050611N1
Registration date:2021-05-22, 1400/03/01
Registration timing:registered_while_recruiting
Last update:2021-05-22, 1400/03/01
Update count:0
Registration date
2021-05-22, 1400/03/01
Registrant information
Name
Naser Amini
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8608 3674
Email address
amini_ot@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-04-22, 1400/02/02
Expected recruitment end date
2022-04-22, 1401/02/02
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial
Public title
Mesenchymal stem cell injection in patients with knee osteoarthritis compared to a randomized controlled trial
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Knee Osteoarthritis Based on American College of Rheumatology Criteria in Grades 1, 2, and 3: Lowrence - Kellergan
Knee pain for at least six months
Proper liver function (Bilirubin ≤ 2.0 ㎎/㎗, AST/ALT ≤ 100 IU/L)
Proper renal function (Creatinine ≤ 2.0 ㎎/㎗)
Exclusion criteria:
Any acute or chronic infection
Pregnancy or decision to become pregnant
Any intra-articular injection during the last three months
Inflammatory joint disease or secondary osteoarthritis
History of knee surgery
Severe underlying disease such as uncontrolled diabetes, taking anticoagulants
Daily use of opioid and non-opioid analgesics
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
After being selected according to the entry criteria, individuals receive a numeric code from one to eighty, then to form blocks of 4, eligible individuals are randomly divided into 20 groups by naming the letters of the alphabet. In each block with letters alphabetically, one person is selected randomly and the third person is selected by lottery, and this person is selected as the control group of each block, and in each block, the remaining three people are considered as the intervention group. It should be noted that this type of random selection is done by lottery method and blind.
Blinding (investigator's opinion)
Double blinded
Blinding description
The study is a double-blind clinical trial.
Primary blinding: Outcome evaluation tests are performed by an expert before and after the intervention. The relevant expert is unaware of how to block, select the subjects and the tests related to them. The relevant expert is unaware of the studied groups and this test is performed by a physical medicine and rehabilitation physiatrist.
Placebo
Not used
Assignment
Factorial
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Iran University of Medical Sciences
Street address
Iran University of medical science. beside of Milad tower. Hemmat highway
City
Tehran
Province
Tehran
Postal code
1449614535
Approval date
2021-04-18, 1400/01/29
Ethics committee reference number
IR.IUMS.REC.1400.064
Health conditions studied
1
Description of health condition studied
Knee osteoarthritic
ICD-10 code
M17,
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
Pain: The pain assessment scale is performed by the VAS test. In this questionnaire, which is filled in by the participant before the intervention and six months after the intervention, the least pain in the last trimester is zero and the number 10 is considered as the highest pain in the last trimester. Scores between zero and 10 for the amount of pain.
Timepoint
Before intervention and 6 months after injection
Method of measurement
VAS questionnaire
Secondary outcomes
1
Description
Pain due to inflammation in the knee joint in the last 6 months
Timepoint
Before the intervention and 6 months later
Method of measurement
The VAS questionnaire is filled out by the patient for the amount of pain and the patient scores from 0 to 10 according to the amount of pain.
2
Description
The range of motion of the knee joint from the extent position to 140 degrees is measured in both active and passive forms.
Timepoint
Before intervention and 6 months after injection
Method of measurement
Goniometer
3
Description
Knee cartilage formation using MRI image
Timepoint
Before intervention and 6 months after injection
Method of measurement
MRI image of the knee in a supine position
Intervention groups
1
Description
Cell therapy is a branch of modern regenerative medicine that uses autologous or allogeneic stem cells to treat many untreated diseases, including knee osteoarthritis. Stem cells are prepared for cell therapy in a sterile and clean environment. In this study, 8 million adipose-derived stem cells in two milliliters of normal saline were injected into each patient's knee under an ultrasound guide. Before the stem cell injection, a two-hour session is considered to explain and teach the patient the treatment method, satisfaction as well as post-injection care. After selecting the patient to study, the time required for patient availability is eight months. adipose-derived stem cells after isolation, culture, characterization and quality control tests are performed in a clean room with grade A and B clean room of Motahhari Hospital and under sterile conditions, by experts in this field.
Category
Treatment - Other
2
Description
Control group: A quarter of all patients in the control group will be evaluated clinically and radiologically at intervals of one and six months. These patients will be given knee care training in daily life activities and to participate in this The project must be submitted so that during this period they will not receive any other therapeutic intervention. If they receive any therapeutic intervention, inform the project manager to remove them from the project. Tests for goniometry, pain, cartilage thickness will be taken at intervals of one to six months.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Sports Medicine Center of Hazrat Rasoul Hospital
Full name of responsible person
Parisa Nejati
Street address
Hazrat rasoul Hospital. Sattarkhan street
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8608 3674
Email
parisanejati2@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naser Amini
Street address
Hemmat Highway, next to Milad Tower. Iran University of Medical Sciences
City
Tehran
Province
Tehran
Postal code
1449614535
Phone
+98 21 8608 3674
Email
Amini_ot@yahoo.com
Grant name
Research AssistantIran University of Medical Sciences
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
50
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
Iran University of Medical Sciences
Full name of responsible person
Naser amini
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mottahari Hospital.Yasemi avenue. Valiasr street
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8608 3674
Email
Amini_ot@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naser Amini
Position
Assistance professor
Latest degree
Ph.D.
Other areas of specialty/work
Neuroscience
Street address
Mottahari Hospital. yasemi street. Valiasr avenue
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8608 3674
Email
amini_ot@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Naser Amini
Position
professor assistant
Latest degree
Ph.D.
Other areas of specialty/work
Cell therapy
Street address
Comprehensive stem cell center, Motahhari Hospital, Rashid Yasemi St,Valiasr Street.
City
Tehran
Province
Tehran
Postal code
1996714353
Phone
+98 21 8608 3674
Fax
+98 21 8608 3674
Email
amini_ot@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD