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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01375062
Other study ID # 0902-057-F-CS
Secondary ID
Status Completed
Phase N/A
First received June 7, 2011
Last updated October 16, 2015
Start date May 2009
Est. completion date July 2011

Study information

Verified date March 2014
Source Igenomix
Contact n/a
Is FDA regulated No
Health authority Spain: Ministry of Health
Study type Interventional

Clinical Trial Summary

The purpose of this study is to isolate and culture stem cell from adult human testicular biopsies for future transplantation in fertility preservation.


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).


Recruitment information / eligibility

Status Completed
Enrollment 65
Est. completion date July 2011
Est. primary completion date July 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years and older
Eligibility Inclusion Criteria:

-azoospermic patients

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Other:
analyse and proliferate the cells
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.

Locations

Country Name City State
Spain IVI Valencia Valencia

Sponsors (1)

Lead Sponsor Collaborator
Igenomix

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Assessment of potential germinal and pluripotent of the isolated cultures. •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.
one month No
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