NCT02043743

Brief Summary

Premature ovarian failure (POF), also known as premature ovarian insufficiency, primary ovarian insufficiency (this is the most accurate term as some women may still conceive), premature menopause, hypergonadotropic hypogonadism is defined as failure of the ovary to function adequately in a woman younger than 40 years, in its role either as an endocrine organ or as a reproductive organ, a condition characterized by amenorrhea, hypoestrogenism, and elevated serum gonadotropin levels (which demonstrate that the ovaries are no longer responding to circulating FSH by producing estrogen and developing fertile eggs) in women younger than 40 years. This condition occurs in approximately 1% of women and it has important physical and psychological consequences/impact in those patients. The purpose of this study is to investigate the role of the transplantation of bone marrow derived stem cells into ovarian tissue for treatment of premature ovarian failure and to assess their ability to differentiate into germ cells.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Jan 2014

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
13 days until next milestone

First Posted

Study publicly available on registry

January 23, 2014

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2015

Completed
Last Updated

January 23, 2014

Status Verified

January 1, 2014

Enrollment Period

3 months

First QC Date

January 10, 2014

Last Update Submit

January 21, 2014

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • Cases Improvement

    Decline in serum FSH level. Rise in serum estrogen level Elevation in serum AMH level

    48 Weeks

Secondary Outcomes (1)

  • Cases Improvement

    48 Weeks

Study Arms (1)

Laboratory and Clinical

EXPERIMENTAL

Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally injected into rete testis. Stem Cell Dose: •3-5 Million Autologous MSCs Injected into Ovarian tissue.

Biological: Biological: Stem Cells

Interventions

Biological: Stem CellsBIOLOGICAL

Biological: Stem Cells 60 ml of bone marrow will aspirated and used for stem cells isolation. Then stem cells will cultured using autologous serum, characterized and prepared using GMP rules and finally 3-5 million MSCs injected into ovarian tissue.

Also known as: Stem Cells Transplantation
Laboratory and Clinical

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Patients with normal karyotype spontaneous premature ovarian failure.
  • Patients between 18 - 40 years old.

You may not qualify if:

  • Patients with secondary ovarian failure (e.g. hypothalamic causes).
  • Pregnancy and lactation.
  • Autoimmune diseases.
  • Those with major medical problems such as malignancy, hepatitis, etc.
  • Abnormal karyotyping (e.g. turner syndrome, fragile X syndrome….).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

El-Rayadh Fertility Center

Giza, Egypt

RECRUITING

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Interventions

Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Ovarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesGonadal DisordersEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Cell TransplantationCell- and Tissue-Based TherapyBiological TherapyTherapeuticsTransplantationSurgical Procedures, Operative

Study Officials

  • Prof.Dr. Hesham Elshaer, MD

    El-Rayadh Fertility Center

    PRINCIPAL INVESTIGATOR

  • Sayed Bakry, PhD

    Al-Azhar University

    STUDY DIRECTOR

  • Wael Abu El Khier, MD

    Military Academy

    STUDY CHAIR

  • Hala Gabr, MD

    Cairo University

    STUDY CHAIR

Central Study Contacts

Hesham Elshaer, MD

CONTACT

+201223130881dr.heshamelshaer@hotmail.com

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 23, 2014

Study Start

January 1, 2014

Primary Completion

April 1, 2014

Study Completion

January 1, 2015

Last Updated

January 23, 2014

Record last verified: 2014-01

Locations

EG(1)