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Obtaining Undifferentiated Cells From Testis Biopsy

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01375062
First Posted: June 17, 2011
Last Update Posted: October 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
  Purpose
The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.

Condition Intervention
Azoospermia Other: analyse and proliferate the cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Isolation, Culture and Characterization Stem Cells From Testis Biopsy

Resource links provided by NLM:


Further study details as provided by Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA:

Primary Outcome Measures:
  • Assessment of potential germinal and pluripotent of the isolated cultures. [ Time Frame: one month ]

    •The spermatogonial cells isolated from testicular biopsies of azoospermic patients will be matured in vitro for thegeneration of sperm for infertility treatment.

    * Undifferentiated cells of the testis biopsy will be characterized as degrees of plasticity for proof that they are capable of regeneration spermatogenesis.



Enrollment: 65
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: tissue from biopsies Other: analyse and proliferate the cells
  1. Obtention of excess tissue from testicular biopsies and maintained in 4ºC until procedures.
  2. Digestion of the biopsies through controlled enzymes
  3. Replication of the cells
  4. Selection undifferentiated cells
  5. Expansion of the purification cells population
  6. Characterization of the cell population
  7. Assessment of pluripotent and germinal cell potential.
  8. Possible maturation of the cells.

Detailed Description:
Testicular biopsies were obtained from azoospermic patients as part of their diagnosis and work-up after obtaining a signed informed consent. A portion of each sample was mechanically dissected in PBS with 1% Pen/Strep. For enzymatic digestion samples were incubated with 0.5g/ml Collagenase type 1A for 20min and TripLE Select for 15min at 37ºC on a shaker and then filtered with 30µm and centrifuged at 1,000rpm. The pellets were seeded and incubated in embryonic stem cell media (hESC) with glial cell line-derived neurotrophic factor (GDNF 4ng/mL) for 5-7 days at 37ºC (1st culture). To identify and isolate SSCs they were marked with CD49f antibody and FACS sorted. Positive cells were cultured in gelatine plates containing hESC media with leukaemia inhibitory factor (LIF1000U/mL) (2nd culture).
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-azoospermic patients

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01375062


Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Igenomix
Investigators
Study Director: Carlos Simon, MDPhD IVI Valencia
Principal Investigator: Marcia Riboldi, PhD Fundación IVI
  More Information

Responsible Party: Carlos Simon, Principal Investigator; Gynecologist IVI Valencia, Instituto Valenciano de Infertilidad, IVI VALENCIA
ClinicalTrials.gov Identifier: NCT01375062     History of Changes
Other Study ID Numbers: 0902-057-F-CS
First Submitted: June 7, 2011
First Posted: June 17, 2011
Last Update Posted: October 19, 2015
Last Verified: March 2014

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