Investigating the effectiveness of stem cell-derived exosomes in bone repair
Design
The present study is a quasi-experimental before-and-after study without a control group that will be conducted on 10 patients who refer to the orthopedic clinic of Imam Khomeini Hospital in Sari city with nonunion problems. This study is open Labell and without a control group.
Settings and conduct
in the operating room of Imam Khomeini hospital in Sari city, after prep and drape, under sterile conditions under C-arm, first aspiration of the area secretion for culture is performed and then exosome injection is performed. After exosome injection, one cc of hyaluronic acid will be injected to maintain this substance in place. Finally, the patient is treated with antibiotic prophylaxis (cephalexin 500 capsules every 6 hours) for three days. The injection site is examined for inflammatory reaction on the third day and a week after the injection. The patient will be followed up for six months and during this period, radiographs will be performed four times at 45-day intervals to determine the progress of the union. Finally, after the injection, patients will be followed up for six months and during this period, radiographs will be performed four times (at 45-day intervals) to determine the progress of the union.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients with non-union in long bone fractures after 6 months
Exclusion criteria: Patients with corticosteroids and a history of immunodeficiency and diabetes
Intervention groups
1 cc of exosomes containing 200 micrograms of total protein is injected into the fracture site.
Main outcome variables
Callus formation at the fracture site
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210228050535N4
Registration date:2025-04-28, 1404/02/08
Registration timing:prospective
Last update:2025-04-28, 1404/02/08
Update count:0
Registration date
2025-04-28, 1404/02/08
Registrant information
Name
Amirali Khodashenas limoni
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 11 3354 3353
Email address
s.khodashenas@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-05-05, 1404/02/15
Expected recruitment end date
2025-08-25, 1404/06/03
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effectiveness of injection of mesenchymal stem cells' exosome in the treatment of bone non-union
Public title
The treatment of bone non-union by exosome therapy
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with nonunion, long bone fractures after proper fixation
Patients who have fracture site degradation visible on radiographs and tenderness at the fracture site, evidence of which persists 6 months after appropriate surgical fixation, indicating nonunion of the fracture.
Patients with nonunion who have had more than one surgery and fixation
Exclusion criteria:
Unwillingness to participate in the study
Use of corticosteroids
History of immunodeficiency and diabetes from the study
Age
No age limit
Gender
Both
Phase
1
Groups that have been masked
No information
Sample size
Target sample size:
10
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committees of Imam Hospital-Mazandaran University of Medical Sciences
Street address
Amir Mazandarani St
City
Sari
Province
Mazandaran
Postal code
4816633131
Approval date
2024-11-27, 1403/09/07
Ethics committee reference number
IR.MAZUMS.IMAMHOSPITAL.REC.1403.061
Health conditions studied
1
Description of health condition studied
Nonunion of fracture
ICD-10 code
M84.1
ICD-10 code description
Nonunion of fracture
Primary outcomes
1
Description
callus formation
Timepoint
1 month after injection
Method of measurement
radiography
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: In the operating room after prep and drape, under sterile conditions under C-arm, first aspiration of the area secretion for culture is performed and then exosome injection is performed. After exosome injection, one cc of hyaluronic acid will be injected to maintain this substance in place. Finally, the patient is treated with antibiotic prophylaxis (cephalexin 500 capsules every 6 hours) for three days. The injection site is examined for inflammatory reaction on the third day and a week after the injection. The patient will be followed up for six months and during this period, radiographs will be performed four times at 45-day intervals to determine the progress of the union. Finally, after the injection, patients will be followed up for six months and during this period, radiographs will be performed four times (at 45-day intervals) to determine the progress of the union.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
imam khomaini hospital
Full name of responsible person
Masoud shayasteh azar
Street address
Amir mazandarani bulvar
City
Sari
Province
Mazandaran
Postal code
4816633131
Phone
+98 11 3432 3434
Email
mshayestehazar@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
ahmadali Enayti
Street address
University of Medical sciences Moallem square,Sari.Iran.
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
shabanalikhodashenas@gmail.com
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
Shabanali Khodashenas limoni
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Medical Biotechnology
Street address
Department of medical biotechnology, Faculty of Advanced Medical Sciences, Payambar Azam Camplex, Farah Abad Bulvd
City
Sari
Province
Mazandaran
Postal code
481693456
Phone
+98 11 3354 3353
Fax
Email
s.khodashenas@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Masoud Shayestehazar
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Orthopedics
Street address
Amir Mazandarani bulvar
City
Sari
Province
Mazandaran
Postal code
4816934561
Phone
+98 11 3434 3405
Email
mshayestehazar@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shabanali Khodashenas Limoni
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Medical Biotechnology
Street address
Mazandaran University of Medical Sciences,17 km of Farahabad Road, Farahabad Square
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3311 8945
Email
s.khodashenas@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