NCT02025270

Brief Summary

In this study, we performed autologous BMDMSC transplantation to the testis of Azoospermic patients in a trial to enhance and activate the spermatogonial stem cells of the testis and aiming to produce motile sperm.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started Oct 2012

Longer than P75 for phase_1

Geographic Reach
1 country

1 active site

Status
completed

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

October 15, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

December 13, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

January 1, 2014

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 15, 2016

Completed
6.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

March 1, 2023

Status Verified

February 1, 2023

Enrollment Period

4 years

First QC Date

December 13, 2013

Last Update Submit

February 28, 2023

Conditions

Male Infertility

Keywords

Azoospermia, Spermatogonial Arrest, Maturation Arrest.

Outcome Measures

Primary Outcomes (1)

  • All Cases Improvement

    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potency.

    One Year (12-Month)

Secondary Outcomes (1)

  • All Cases Fertility Improvement

    One Year (12-Month)

Study Arms (1)

Laboratory and Clinical

OTHER

60 ml of Bone marrow will aspirated for stem cells isolation and preparation. 5 ml of stem cells prepared according to GMP rules injected into rete testis.

Biological: Stem Cells

Interventions

Stem CellsBIOLOGICAL

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.

Also known as: Stem Cell Dose, 3-5 Million Autologous MSCs Injected into rete testis.
Laboratory and Clinical

Eligibility Criteria

Age20 Years - 50 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • All Non obstructive Azoospermic Patients.
  • Azoospermic Patients due to Administration of Chemo/Radiotherapy.

You may not qualify if:

  • Patients with Testicular Cancer.
  • Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al Azhar University , School of Medicine

Cairo, 11884, Egypt

Location

MeSH Terms

Conditions

Infertility, MaleAzoospermia

Condition Hierarchy (Ancestors)

Genital Diseases, MaleGenital DiseasesUrogenital DiseasesInfertilityMale Urogenital Diseases

Study Officials

  • Taimour M Khalifa, MD Professor

    Al-Azhar University

    PRINCIPAL INVESTIGATOR

  • Sayed Bakry, PhD

    Al-Azhar University

    STUDY DIRECTOR

  • Saad Moneer, MSc

    Al-Azhar University

    STUDY CHAIR

  • Ahmed Kadeh, MSc

    Al-Azhar University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor , Consultant of Separation and Culturing of Stem Cells

Study Record Dates

First Submitted

December 13, 2013

First Posted

January 1, 2014

Study Start

October 15, 2012

Primary Completion

October 15, 2016

Study Completion

December 20, 2022

Last Updated

March 1, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

Locations

EG(1)