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The mesenchymal stem cell-derived extracellular vesicles for primary postmenopausal osteoporosis: A safety, feasibility, and efficacy trial.

Protocol summary

Study aim
Determining the safety, feasibility, and efficacy of extracellular vesicles derived from mesenchymal stem cells for postmenopausal osteoporosis
Design
A randomized controlled clinical trial, phase 1-2, with three parallel arms on 30 patients. RAS will be used for randomization.
Settings and conduct
Thirty postmenopausal women suffering from osteoporosis referring to the clinics of physical medicine and rehabilitation at Imam Reza Hospital-Tabriz University of Medical Sciences will be randomly assigned into two interventions and one control group (alendronate sodium) using block randomization method with a 1:1:1 allocation ratio. It is not possible to blind the control group.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Menopausal women aged 50 to 70 years with a bone mineral density less than 2.5 in the lumbar vertebrae, pelvis, or femoral neck. Exclusion criteria: Suffering from renal failure and diseases; Suffering from bone diseases other than osteoporosis; Taking drugs that affect bone metabolism; Suffering from mental illness; Having malignancy.
Intervention groups
The first group will receive intravenous extracellular vesicles (EVs) with alendronate sodium tablets, the second group will receive intravenous EVs and placebo of alendronate sodium, and the control group will receive only alendronate sodium for 1 year. All groups will receive recommendations based on physical activity and food intake. Participants in the first and second groups at the beginning of the study, day 2, day 4, end of the second week, end of the sixth week, and then every 8 weeks for 5 times (total 46 weeks and 10 drug doses) will receive a slow intravenous injection of 15 ml of EVs
Main outcome variables
The rate of enrollment and retention of participants in study groups, changes in the serum inflammatory and anti-inflammatory factors, Changes in the serum bone turnover markers

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20131009014957N15
Registration date: 2023-09-26, 1402/07/04
Registration timing: prospective

Last update: 2023-09-26, 1402/07/04
Update count: 0
Registration date
2023-09-26, 1402/07/04
Registrant information
Name
Azizeh Farshbaf-khalili
Name of organization / entity
Tabriz university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 1333 9151
Email address
farshbafa@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-11-17, 1402/08/26
Expected recruitment end date
2025-05-16, 1404/02/26
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The mesenchymal stem cell-derived extracellular vesicles for primary postmenopausal osteoporosis: A safety, feasibility, and efficacy trial.
Public title
The mesenchymal stem cell-derived extracellular vesicles for postmenopausal osteoporosis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Having the ability to self-care A resident of Tabriz city Cessation of menstruation for at least 12 consecutive months Having a bone density of less than 2.5 in the lumbar vertebrae, pelvis, or femoral neck No history of fracture
Exclusion criteria:
T-score≤-4 in lumbar vertebrae, T-score≤-3.5 in pelvic bone and femoral neck, history of hip or vertebrae fractures Suffering from renal failure and diseases Having bone diseases other than osteoporosis Taking drugs that affect bone metabolism Having a mental illness according to the patient's own statement Malignancy according to the patient's own statement Peptic ulcers and malabsorption disorders 25-(OH) Vitamin D levels < 20ng/ml or current hypercalcemia or hypocalcemia
Age
From 50 years old to 70 years old
Gender
Female
Phase
1-2
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Thirty eligible postmenopausal women with osteoporosis will be randomized into three groups receiving intravenous extracellular vesicles (EVs) along with sodium alendronate tablets (10 people), intravenous EVS without alendronate sodium, and alendronate sodium without EVs (control group) by blocking method using blocks 3 and 6, and an allocation ratio of 1:1:1 through RAS (Random Allocation Software) and will receive the allocated intervention for one year. The random sequence of allocation will be generated by a person not involved in the research. 30 opaque and identical envelopes will be numbered from 1 to 30, and the type of intervention will be written on paper and placed inside the envelopes based on the generated sequence and will be sealed. Participants in the first and second groups at the beginning of the study, day 2, day 4, the end of the second week, the end of the sixth week, and then every 8 weeks for 5 times (a total of 46 weeks and 10 drug doses) will receive a slow intravenous injection of 15 ml of EVs.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Vice Chancellor for Research and Technology, Third floor, No 2-central building, Tabriz University of Medical Sciences, Golgasht Street
City
Tabriz
Province
East Azarbaijan
Postal code
5165665931
Approval date
2023-05-08, 1402/02/18
Ethics committee reference number
IR.TBZMED.REC.1402.130

Health conditions studied

1

Description of health condition studied
Postmenopausal osteoporosis
ICD-10 code
M81
ICD-10 code description
Osteoporosis without pathological fracture

Primary outcomes

1

Description
The rate and severity of adverse events in the study groups
Timepoint
During one year of intervention
Method of measurement
Through recording in the questionnaire and phone calls

2

Description
The rate of enrollment and retention of participants in study groups
Timepoint
During one year of intervention
Method of measurement
Researcher's own follow-up

3

Description
Changes in the levels of some inflammatory and anti-inflammatory factors (TNF-α, HS-CRP, IL-10 and IL-6)
Timepoint
The beginning and end of the intervention
Method of measurement
Using biochemical methods

4

Description
Changes in the levels of serum bone resorption markers (osteocalcin, P1NP, BSAP, CTX)
Timepoint
The beginning and end of the intervention
Method of measurement
Using biochemical methods and ELISA kit

Secondary outcomes

1

Description
Changes in bone density (T-score, BMD Z-score)
Timepoint
The beginning and end of the intervention
Method of measurement
Using a densitometry device

2

Description
Changes in the levels of some oxidative stress factors (TAC, SOD, MDA)
Timepoint
The beginning and end of the intervention
Method of measurement
Using biochemical methods

3

Description
Nutritional status (appetite status, average weight, BMI, waist circumference, ratio of waist circumference to hip circumference)
Timepoint
The beginning, middle and end of the intervention
Method of measurement
Questionnaire and anthropometric methods

Intervention groups

1

Description
Intervention group 1: Receiving intravenous extracellular vesicles derived from stem cells Mesenchymal (MSCs-EV) together with alendronate sodium tablets 70 mg once a week until the end of one year. This group will receive slow intravenous injections of 15 ml MSCs-EV at the beginning of the study, on day 2, day 4, at the end of the second week, at the end of the sixth week, and then every 8 weeks for 5 times (a total of 46 weeks and 10 drug doses) containing 10.5 x 10^8 EV. This material will be prepared in the clean room of the Stem Cell Innovation Center by the relevant specialist of the project according to the necessary standards.
Category
Treatment - Drugs

2

Description
Intervention group 2: Receiving intravenous extracellular vesicles derived from stem cells Mesenchymal (MSCs-EV) together with placebo tablets of alendronate sodium 70 mg once a week until the end of one year. This group will receive slow intravenous injections of 15 ml MSCs-EV at the beginning of the study, on day 2, day 4, at the end of the second week, at the end of the sixth week, and then every 8 weeks for 5 times (a total of 46 weeks and 10 drug doses) containing 10.5 x 10^8 EV. This material will be prepared in the clean room of the Stem Cell Innovation Center by the relevant specialist of the project according to the necessary standards.
Category
Treatment - Drugs

3

Description
Control group: Receiving alendronate sodium tablets 70 mg once weekly until the end of one year without extracellular vesicles.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Physical Medicine and Rehabilitation Research Center
Full name of responsible person
Azizeh Farshbaf-Khalili
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences; Attar Neishabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Parviz Shahabi
Street address
Central building of Tabriz University of Medical Sciences., Azadi St., Golgasht St
City
Tabriz
Province
East Azarbaijan
Postal code
5166616471
Phone
+98 41 3335 7310
Email
parvizshahabi@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-Khalili
Position
Assistant Professor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Bina Eftekharsadat
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Physical Medicine
Street address
Imam Reza Hospital, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
binasadat@yahoo.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Azizeh Farshbaf-khalili
Position
Assistant Profeassor
Latest degree
Ph.D.
Other areas of specialty/work
Nutrition
Street address
Nutrition Research Center, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3337 1134
Email
farshbafa@tbzmed.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is 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
Title and more details about the data/document
Data on the main outcome will be published
When the data will become available and for how long
Six months after printing the results
To whom data/document is available
Researchers at institutions have access to data
Under which criteria data/document could be used
In order to help scientific progress in the field of research
From where data/document is obtainable
farshbafa@tbzmed.ac.ir
What processes are involved for a request to access data/document
Scientific approval of the applicant by Tabriz University of Medical Sciences
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