Obtaining Undifferentiated Cells From Testis Biopsy

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. Identifier: NCT01375062
Recruitment Status : Completed
First Posted : June 17, 2011
Last Update Posted : October 19, 2015
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA

June 7, 2011
June 17, 2011
October 19, 2015
May 2009
July 2011   (Final data collection date for primary outcome measure)
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.

Same as current
Complete list of historical versions of study NCT01375062 on Archive Site
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Obtaining Undifferentiated Cells From Testis Biopsy
Isolation, Culture and Characterization Stem Cells From Testis Biopsy
The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.
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).
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Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
No Intervention: tissue from biopsies
Intervention: Other: analyse and proliferate the cells
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
July 2011
July 2011   (Final data collection date for primary outcome measure)

Inclusion Criteria:

-azoospermic patients

Sexes Eligible for Study: Male
18 Years and older   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Carlos Simon, Instituto Valenciano de Infertilidad, IVI VALENCIA
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Study Director: Carlos Simon, MDPhD IVI Valencia
Principal Investigator: Marcia Riboldi, PhD Fundación IVI
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP