Trial record 16 of 33 for:    Open Studies | "Infertility, Male"

MSCs For Treatment of Azoospermic Patients

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by Al-Azhar University
Sponsor:
Collaborator:
Cairo University
Information provided by (Responsible Party):
Sayed Bakry, Al-Azhar University
ClinicalTrials.gov Identifier:
NCT02025270
First received: December 13, 2013
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Male Infertility
Biological: Stem Cells
Phase 1
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using of Bone Marrow Derived Mesenchymal Stem Cells For Treatment of Azoospermic Patients

Resource links provided by NLM:


Further study details as provided by Al-Azhar University:

Primary Outcome Measures:
  • All Cases Improvement [ Time Frame: One Year (12-Month) ] [ Designated as safety issue: Yes ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin). Testicular Size. Sexual Potencey.


Secondary Outcome Measures:
  • All Cases Fertility Improvement [ Time Frame: One Year (12-Month) ] [ Designated as safety issue: Yes ]
    Hormonal Assessment: Serum (Testosterone , FSH, LH and Prolactin) Testicular size and Sexual Potencey.


Estimated Enrollment: 100
Study Start Date: October 2012
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.
Other Names:
  • Stem Cell Dose
  • 3-5 Million Autologous MSCs Injected into rete testis.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02025270

Contacts
Contact: Taimour M Khalifa, MD +201222115517 taimour.khalifa@azher.edu.eg
Contact: Sayed Bakry, PhD +201006609978 sayed.bakry@yahoo.com

Locations
Egypt
Al Azhar University , School of Medicine Recruiting
Nasr City, Cairo, Egypt, 11884
Contact: Sayed Bakry, PhD    +201006609978    sayed.bakry@yahoo.com   
Principal Investigator: Taimour Khalifa, MD         
Sub-Investigator: Sayed Bakry, PhD         
Sub-Investigator: Hala Gabr, MD         
Sub-Investigator: Wael Abu El Khier, MD         
Sponsors and Collaborators
Al-Azhar University
Cairo University
Investigators
Principal Investigator: Taimour M Khalifa, MD Professor Al-Azhar University
Study Director: Sayed Bakry, PhD Al-Azhar University
Study Chair: Hala Gabr, MD Cairo University
Study Chair: Wael Abu Elkhier, MD Miltary Academy
Study Chair: Saad Moneer, MSc Al-Azhar University
  More Information

No publications provided

Responsible Party: Sayed Bakry, Associate Professor , Consultant of Separation and Culturing of Stem Cells, Al-Azhar University
ClinicalTrials.gov Identifier: NCT02025270     History of Changes
Other Study ID Numbers: NCT010066099, Azhar23052011
Study First Received: December 13, 2013
Last Updated: February 12, 2014
Health Authority: Egypt: Ministry of Health and Population

Keywords provided by Al-Azhar University:
Azoospermia, Spermatogonial Arrest, Maturation Arrest.

Additional relevant MeSH terms:
Infertility
Infertility, Male
Genital Diseases, Male
Genital Diseases, Female

ClinicalTrials.gov processed this record on September 18, 2014