Investigating the safety of intra-articular injection of t-SVF in patients with knee osteoarthritis
Design
A clinical study has a control group and a parallel group, randomized by envelope and block method for 20 patients.
Settings and conduct
The leading study presents a new cell therapy approach for cartilage tissue repair in patients with osteoarthritis. Also, this study will be conducted in Tajrish Martyrs Hospital, Shahid Beheshti University of Medical Sciences. 20 patients will be randomly selected based on the inclusion and exclusion criteria. In the intervention group, t-SVF isolated from adipose tissue will be autologously injected intra-articularly for 10 patients. Patients of the control group (10 people) will receive hyaluronic acid hydrogel, which is commercially available, in the form of joint injections.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged 50 to 75 years with grade 2 and 3 osteoarthritis and WOMAC test less than 8 in the knee without underlying disease or medical intervention in the past.
Exclusion criteria:
•Damage to Minsk
•Severe swelling and inflammation in the knee area
•Rupture of knee ligaments
•Pain caused by dislocation or fracture of kneecap
•People who have a history of systemic diseases, including diabetes, bleeding disorders.
•Women who were pregnant during the study or were planning to become pregnant.
•People who have received oral steroids for a long time.
•History of any chemotherapy or radiation therapy in both parts of the knee and the fat tissue donor area
Intervention groups
Intervention group: injection of t-SVF into the knee joint. Control group: injection of hyaluronic hydrogel into the knee joint
Main outcome variables
Safety of intra-articular injection
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20181205041860N2
Registration date:2023-06-10, 1402/03/20
Registration timing:prospective
Last update:2023-06-10, 1402/03/20
Update count:0
Registration date
2023-06-10, 1402/03/20
Registrant information
Name
Mahboubeh Bohlouli
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2243 9848
Email address
bohlouli98@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-06-22, 1402/04/01
Expected recruitment end date
2023-12-22, 1402/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of the safety of intra-articular injection of t-SVF in patients with osteoarthritis of the knee: a clinical trial, controlled and phase I
Public title
Evaluation of the safety of t-SVF in osteoarthritis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Unilateral or bilateral knee osteoarthritis is diagnosed using MRI imaging and is class II, III according to Quaterbridge criteria.
There is complete damage to the thickness of the cartilage tissue, whose size is less than 1.5 cm in terms of surface.
WOMAC test of the patient should be less than 8
The age of the patient should be between 50 and 75
Body mass index of patients should be between 22 and 37.
Exclusion criteria:
Damage to Minsk
There is a complete damage to the thickness of the cartilage tissue, which is more than 1.5 cm in terms of surface.
Osteochondritis dissections
Parameniscal and Bakers or ganglion cysts
Lipoma arborescens
Hoffa'spad syndrome
Severe swelling and inflammation in the knee area
Rupture of knee ligaments
Pain caused by dislocation or fracture of kneecap
The classification of knee injury should be based on Quterbridge Class IV criteria.
Classification of knee injury should be based on Quterbridge class IV criteria, but the size of the lesion should be more than 1.5 cm.
People who have been injected with drugs such as corticosteroids, Vasosupplementation and cell products including SVF, stem cells, platelet-enriched plasma in the last 6 months.
People who have had knee surgery in the last 6 months.
People who have a history of systemic diseases, including diabetes, bleeding disorders.
Women who were pregnant during the study or were planning to become pregnant.
People who have received oral steroids for a long time.
History of any chemotherapy or radiation therapy in both parts of the knee and the fat tissue donor area
Age
From 50 years old to 75 years old
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
20
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, randomization is performed using the block method using SAS software.
twenty patient will be involved in the study, which will be classified into two groups. to avoid identifying the last patient by medical staff, 5 blocks with 6 wells will be designed that only 4 wells per each block will be considered.
To conceal randomization, each block will be placed in an envelope and all researchers will unaware of the contents of the envelopes. Therefore, a non-study individual was selected to perform all these steps to inform the physician of the result.
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
Ethics Committee of Shahid Beheshti University of Medical Sciences
Street address
Arabi St, student Blvd, Velenjac
City
Tehran
Province
Tehran
Postal code
1985717443
Approval date
2022-05-15, 1401/02/25
Ethics committee reference number
IR.SBMU.RETECH.REC.1401.083
Health conditions studied
1
Description of health condition studied
Osteoarthirits
ICD-10 code
M15
ICD-10 code description
Polyosteoarthritis
2
Description of health condition studied
Osteoarthritis of the knee
ICD-10 code
M17
ICD-10 code description
Osteoarthritis of knee
Primary outcomes
1
Description
The primary outcome of this study is safety, which will be evaluated with the occurrence of side effects in patients
Timepoint
The patient will be visited one and six days as well as 1 and 6 months after injection. But during this time, if patients have any abnormal clinical symptoms, you will be counseled or visited by telephone or in person.
Method of measurement
In order to check safety, different parameters such as infection, inflammation, formation of fibrotic tissue, local edema, local erythema, pain and mortality will be evaluated through clinical evaluations, blood tests, MRI.
Secondary outcomes
1
Description
Cartilage regeneration
Timepoint
After 6 months of injection
Method of measurement
Clinical evaluations, blood tests, MRI.
Intervention groups
1
Description
The intervention group includes 10 patients who receive autologous and intra-articular t-SVF isolated from adipose tissue.
Category
Treatment - Other
2
Description
The control group includes 10 patients who receive hyaluronic acid hydrogel commercially and intra-articularly
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shohadaye Tajrish Hospital
Full name of responsible person
Dr. Adel Ebrahimpour
Street address
Shahdari St, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1989934148
Phone
+98 912 124 2388
Email
a.ebrahimpour@sbmu.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Dr. Afshin Zarghi
Street address
Arabi St, Student Blvd, Velenjak
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 2243 9780
Email
info@sbmu.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Beheshti 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
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboubeh Bohlouli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell Therapy
Street address
No. 53, West Qabadian Alley, above Vanak Square, Valiasr St
City
Tehran
Province
Tehran
Postal code
1688747564
Phone
+98 21 8866 6149
Email
bohlouli98@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Adel Ebrahimpour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Shahdari St, Tajrish Square
City
Tehran
Province
Tehran
Postal code
1985717443
Phone
+98 21 0000 0000
Email
a.ebrahimpour@sbmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Beheshti University of Medical Sciences
Full name of responsible person
Mahboubeh Bohlouli
Position
Associate professor
Latest degree
Ph.D.
Other areas of specialty/work
Cell Therapy
Street address
No. 53, West Qabadian Alley, above Vanak Square, Valiasr St
City
Tehran
Province
Tehran
Postal code
1688747564
Phone
+98 21 8866 6149
Email
bohlouli98@gmail.com
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