MSCs For Treatment of Azoospermic Patients

NCT ID: NCT02025270

Last Updated: 2023-03-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-10-15

Study Completion Date

2022-12-20

Brief Summary

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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.

Detailed Description

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Bone marrow aspirated and stem cells were isolated, cultured and characterized using flow cytometer. Stem cells prepared according to GMP regulations then injected into rete testis using special syringe. Patients follow up will carried out for a year , three month interval. FSH, testosterone, testicular size as well as sexual potency will assessed every three months.

Conditions

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Male Infertility

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Laboratory and Clinical

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.

Group Type OTHER

Stem Cells

Intervention Type BIOLOGICAL

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.

Interventions

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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.

Intervention Type BIOLOGICAL

Other Intervention Names

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Stem Cell Dose 3-5 Million Autologous MSCs Injected into rete testis.

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients with Testicular Cancer.
* Patients with Complete Deletion of Chromosome Y AZF (a,b,c) Regions.
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role collaborator

Al-Azhar University

OTHER

Sponsor Role lead

Responsible Party

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Sayed Bakry

Associate Professor , Consultant of Separation and Culturing of Stem Cells

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Taimour M Khalifa, MD Professor

Role: PRINCIPAL_INVESTIGATOR

Al-Azhar University

Sayed Bakry, PhD

Role: STUDY_DIRECTOR

Al-Azhar University

Saad Moneer, MSc

Role: STUDY_CHAIR

Al-Azhar University

Ahmed Kadeh, MSc

Role: STUDY_CHAIR

Al-Azhar University

Locations

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Al Azhar University , School of Medicine

Cairo, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Azhar23052011

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

AZH010066099

Identifier Type: -

Identifier Source: org_study_id

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