Obtaining Undifferentiated 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.

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Key information

Conditions

Azoospermia Genital Diseases Genital Diseases, Male Infertility Infertility, Male Male Urogenital Diseases Urogenital Diseases

Age range

18 year and older

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

IVI Valencia

Valencia, 46015, Spain

About this study

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).

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

-azoospermic patients

Treatment and study plan

analyse and proliferate the cells

Other

Obtention of excess tissue from testicular biopsies and maintained in 4ºC until procedures.
Digestion of the biopsies through controlled enzymes
Replication of the cells
Selection undifferentiated cells
Expansion of the purification cells population
Characterization of the cell population
Assessment of pluripotent and germinal cell potential.
Possible maturation of the cells.

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Igenomix

Industry

Registry information

Official study title

Isolation, Culture and Characterization Stem Cells From Testis Biopsy

Important dates

Study start: 2009
Primary completion: 2011
Study completion: 2011
First posted: Jun 17, 2011
Registry last updated: Oct 19, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed