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Clinical Trials/IRCT20080831001141N43
IRCT20080831001141N43
Recruiting
Phase 1

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

otus Royan Charitable Fundation0 sites10 target enrollmentTBD

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Premature ovarian failure.
Sponsor
otus Royan Charitable Fundation
Enrollment
10
Status
Recruiting
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
TBD
End Date
TBD
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
otus Royan Charitable Fundation

Eligibility Criteria

Inclusion Criteria

  • Women between 20\-38 years old
  • Baseline serum level of follicle stimulating hormone (FSH) higher or equal to 25 IU/l at least twice with an interval of 3 or 4 months
  • At least one year has passed since secondary amenorrhea and premature ovarian failure (POF) diagnosis
  • Normal karyotype and fragile X messenger ribonucleoprotein 1 (FMR1\) gene

Exclusion Criteria

  • Primary amenorrhea
  • Congenital anomaly of the ovary
  • Thyroid disease
  • Immune system diseases such as lupus and...
  • Previous and/or family history of ovarian tumor
  • Previous and/or family history of suffering from major diseases in the past and present such as cancer
  • Positive serological evidence regarding previous or current hepatitis B and C, Human T\-lymphotropic virus 1, Human immunodeficiency virus (HIV), Syphilis
  • Disturbance in the normal range of laboratory tests as levels of Hemoglobin Subunit Alpha 1 (HbA1\), Alanine transaminase (ALT), The aspartate aminotransferase (AST), the number of white blood cells (WBCs), The creatinine (Cr), International normalised ratio (INR) , Platelets (Plt), Hematocrit (Hct) tests.
  • History of specific systemic disease (rheumatology, endocrine, cardiovascular, etc.)
  • Severe endometriosis (stage III and IV)

Outcomes

Primary Outcomes

Not specified

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