NCT03069209

Brief Summary

This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived specific populations of stem cells and mesenchymal stem cells injected into the ovaries (intraovarian injection), through a 12 week follow-up period. The investigators' chosen model of study is based on increasing the efficiency of the approach by choosing an autologous model which preserves the genetic composition of an individual that is vital in infertility conditions. Additionally the approach involves transplanting a combination of specific purified stem cell types which all aid in ovarian function recovery.

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
50

participants targeted

Target at P50-P75 for phase_1

Timeline
Completed

Started Jan 2015

Longer than P75 for phase_1

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

First Submitted

Initial submission to the registry

February 25, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 3, 2017

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2021

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2022

Completed
Last Updated

May 17, 2018

Status Verified

May 1, 2018

Enrollment Period

6.4 years

First QC Date

February 25, 2017

Last Update Submit

May 16, 2018

Conditions

Premature Ovarian Failure

Outcome Measures

Primary Outcomes (1)

  • Return of menstrual cycle

    Return of menses in a woman with previous ameneorrhea for at least 6 months before recruitment.

    6 months

Secondary Outcomes (4)

  • Pregnancy

    12 months

  • FSH levels

    12 months

  • Follicular function

    12 months

  • Endometrium thickness

    12 months

Study Arms (1)

Stem Cells

EXPERIMENTAL

Intervention: Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.

Biological: Stem Cells

Interventions

Stem CellsBIOLOGICAL

Intraovarian transplantation of autologous purified bone marrow-derived stem cells and mesenchymal stem cells.

Stem Cells

Eligibility Criteria

Age19 Years - 39 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Female
  • Age : 20-39
  • FSH\>20

You may not qualify if:

  • Thyroid dysfunction
  • Immunological Conditions
  • Past history of malignancy/cemotherapy/radiotherapy
  • Infectious diseases: HIV+, hepatitis B+, C+
  • Abnormal karyotype
  • Previous surgical management of ovarian pathology
  • Severe endometriosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stem Cells Arabia

Amman, 11953, Jordan

Location

MeSH Terms

Conditions

Primary Ovarian Insufficiency

Condition Hierarchy (Ancestors)

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

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

February 25, 2017

First Posted

March 3, 2017

Study Start

January 1, 2015

Primary Completion

June 1, 2021

Study Completion

January 1, 2022

Last Updated

May 17, 2018

Record last verified: 2018-05

Locations

JO(1)