Obtaining Undifferentiated Cells From Testis Biopsy

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01375062
First received: June 7, 2011
Last updated: March 26, 2014
Last verified: March 2014

June 7, 2011
March 26, 2014
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 ] [ Designated as safety issue: No ]

•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 ClinicalTrials.gov Archive Site
Not Provided
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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).

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Azoospermia
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
July 2011
July 2011   (final data collection date for primary outcome measure)

Inclusion Criteria:

-azoospermic patients

Male
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT01375062
0902-057-F-CS
No
Carlos Simon, Instituto Valenciano de Infertilidad, Spain
Igenomix
Not Provided
Study Director: Carlos Simon, MDPhD IVI Valencia
Principal Investigator: Marcia Riboldi, PhD Fundación IVI
Igenomix
March 2014

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