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"It is a Real" The First Baby Of Autologous Stem Cell Therapy in Premature Ovarian Failure

NCT02372474 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 112

Last updated 2015-02-26

No results posted yet for this study

Summary

The purpose of this work is to evaluate the therapeutic potential of Autologous Mesenchymal sc (MSC) therapy in women suffering from POF.

Conditions

  • Premature Ovarian Failure

Interventions

BIOLOGICAL

Stem cell

Out of 112 high risk patients for POF diagnosis was established in 10 cases. Endometrial fractional biopsy was taken, stained with H\&E stain and by Immunohistochemical (IH) staining by stem cell marker OCT4. IH expression of stem cell was evaluated before and after transplantation according to Edessy Stem Cell Scoring (ESS). After laparoscopic injection of stem cell sample in the ovaries, participants were followed up monthly for a period of one year by hormonal (FSH, LH and E2), clinical (resuming menstruation and pregnancy), US (folliculometry), histopathological (HP), and IH expression of stem cell (stem cell positivity and scoring according to ESS).

Sponsors & Collaborators

  • Al-Azhar University

    lead OTHER

Principal Investigators

  • Mahmoud Edessy, Professor · Al-Azhar University

  • Hala N Hosni, Professor · Cairo University

  • Yousef Shdy, MD · Al-Azhar University

  • Syed Bkry, MD · Al-Azhar University

  • Medhat Kamel, Msc · Al-Azhar University

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
40 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-03-31
Primary Completion
2014-12-31
Completion
2014-12-31

Countries

  • Egypt

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02372474 on ClinicalTrials.gov