Ignite Creation Date:
2024-05-06 @ 7:58 PM
Last Modification Date:
2024-10-26 @ 3:17 PM
Study NCT ID:
NCT06202547
Status:
RECRUITING
Last Update Posted:
2024-01-11
First Post:
2023-12-05
Brief Title:
Intra-ovarian Injection of MSC-EVs in Idiopathic Premature Ovarian Failure
Sponsor:
Royan Institute
Organization:
Royan Institute
Study Overview
Official Title:
Safety and Feasibility Study of Intra-ovarian Injection of Bone Marrow Mesenchymal Stromal Cells-derived Extracellular Vesicles in Idiopathic Premature Ovarian Failure Patients Clinical Trial Phase I
Status:
RECRUITING
Status Verified Date:
2024-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Premature ovarian failure POF is a clinical syndrome defined by loss of ovarian activity before the age of 40 years POF is characterized by menstrual disturbance amenorrhea or oligomenorrhea with raised gonadotrophins and low estradiol The prevalence of POF is 1-2 Extracellular vesicles EVs are membrane-packed vesicles that are secreted by a variety of cell types including T cells B cells dendritic cells platelets mast cells epithelial cells endothelial cells neuronal cells cancerous cells oligodendrocytes Schwann cells embryonic cells and mesenchymal stromal cells-derived MSCs MSCs-EV more stable and induce stronger signaling and are produced in higher concentrations than stem cells They demonstrate no inherent toxicity are not associated with any long-term maldifferentiation of engrafted cells or tumor generation and carry no apparent risk of aneuploidy or immune rejection following in vivo allogenic administrationSeveral studies have evaluated the safety and possible efficacy of injection MSCs-EV for the treatment of premature ovarian failure in animal models Based on the available evidence the study was designed with the aim of investigating the safety and effectiveness of intraovarian injection of MSCs-EV in patients with POF diagnosis
Detailed Description:
Investigating the effect of intraovarian injection of bone marrow-derived extracellular vesicles MSC-EV on serum levels of Follicle-Stimulating Hormone FSHAnti-Mullerian Hormone AMH levels as well as the return of the menstrual cycle in infertile patients with premature ovarian failure as well as the evaluation of its possible side effects A beforeafter clinical trial phase I on 10 patients is designed Eligible patients will be included in the study if they have written consent Infertile women who have been diagnosed with premature ovarian failure and have normal body mass index and normal genetic tests are invited to participate in this project Patients with early amenorrhea and certain immunological and cardiovascular diseases as well as a history of ovarian masses or abnormal serological tests will not be included in the study If the patient has undergone hormone replacement therapy HRT the HRT will be stopped for at least two months and then the injection cycle will be startedInjection of bone marrow-derived extracellular vesicles with a dose equivalent to 3 times 10 million clonal mesenchymal stem cells in 2 ml will be performed for all patients Follow-up of patients in order to respond to treatment for 8 months based on evaluation of Follicle-Stimulating Hormone FSHAnti-Mullerian Hormone AMH levels return of menstrual cycle ovarian ultrasound and also check possible complications due to injection fever bacteremia sepsis Pelvic inflammatory disease anaphylactic shock and hematoma from the first 24 hours and in the first week will be done
Primary Outcome Measures Safety evaluation Time Frame 8 monthsEarly-onset possible side effects fever bacteremia sepsis PID anaphylactic shock and hematoma will be evaluated at the first 24 h and during the first week Possible second side effects such as ovarian abscesses and benign or malignant neoplasms will be assessed until 8 months after intra-ovarian EV injection
Secondary Outcome Measures Feasibility evaluation Time Frame 8 months The Serum FSH Estradiol and AMH levels measurements and Return of menstrual cycle will be evaluated until months after intra-ovarian EV injection Ultrasonography evaluation will be performed monthly to evaluate the ovarian volume cc the antral follicle count Endometrium thickness the number and size of the follicles
Primary Outcome Measures Safety evaluation Time Frame 8 monthsEarly-onset possible side effects fever bacteremia sepsis PID anaphylactic shock and hematoma will be evaluated at the first 24 h and during the first week Possible second side effects such as ovarian abscesses and benign or malignant neoplasms will be assessed until 8 months after intra-ovarian EV injection
Secondary Outcome Measures Feasibility evaluation Time Frame 8 months The Serum FSH Estradiol and AMH levels measurements and Return of menstrual cycle will be evaluated until months after intra-ovarian EV injection Ultrasonography evaluation will be performed monthly to evaluate the ovarian volume cc the antral follicle count Endometrium thickness the number and size of the follicles
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| IRCT20080831001141N43 | OTHER | wwwirctir | None |