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IRCT20131009014957N15 IRCT 2023-09-26 Tabriz University of Medical Sciences The mesenchymal stem cell-derived extracellular vesicles for postmenopausal osteoporosis The mesenchymal stem cell-derived extracellular vesicles for primary postmenopausal osteoporosis: A safety, feasibility, and efficacy trial. 2023-11-17 anticipated 30 Complete https://irct.ir/trial/72638 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, 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. 1-2 Postmenopausal osteoporosis. Intervention 1: 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. Intervention 2: 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. Intervention 3: Control group: Receiving alendronate sodium tablets 70 mg once weekly until the end of one year without extracellular vesicles. Yes - There is a plan to make this available What will be shared: Data on the main outcome will be published When: Six months after printing the results To whom: Researchers at institutions have access to data Conditions: In order to help scientific progress in the field of research Where to obtain: farshbafa@tbzmed.ac.ir How to obtain: Scientific approval of the applicant by Tabriz University of Medical Sciences Comments:
public Azizeh Farshbaf-Khalili
Imam Reza Hospital, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3337 1134 farshbafa@tbzmed.ac.ir Tabriz University of Medical Sciences scientific Bina Eftekharsadat
Imam Reza Hospital, Tabriz University of Medical Sciences, Attar Neyshabouri avenue, Golgasht
Tabriz Iran (Islamic Republic of) 5166614711 +98 41 3337 1134 binasadat@yahoo.com Tabriz University of Medical Sciences Iran (Islamic Republic of) 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 50 years 70 years Female 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 M81 Osteoporosis without pathological fracture Treatment - Drugs Treatment - Drugs Treatment - Drugs 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. 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. Control group: Receiving alendronate sodium tablets 70 mg once weekly until the end of one year without extracellular vesicles. 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. 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. 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. 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. Changes in bone density (T-score, BMD Z-score). Timepoint: The beginning and end of the intervention. Method of measurement: Using a densitometry device. 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. 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. Tabriz University of Medical Sciences Approved 2023-05-08 Ethics committee of Tabriz University of Medical Sciences Vice Chancellor for Research and Technology, Third floor, No 2-central building, Tabriz University of Medical Sciences, Golgasht Street Tabriz East Azarbaijan Iran (Islamic Republic of)