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Clinical Trials/NCT01375062
NCT01375062
Completed
Not Applicable

Isolation, Culture and Characterization Stem Cells From Testis Biopsy

Igenomix1 site in 1 country65 target enrollmentMay 2009
ConditionsAzoospermia

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Azoospermia
Sponsor
Igenomix
Enrollment
65
Locations
1
Primary Endpoint
Assessment of potential germinal and pluripotent of the isolated cultures.
Status
Completed
Last Updated
10 years ago

Overview

Brief Summary

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

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).

Registry
clinicaltrials.gov
Start Date
May 2009
End Date
July 2011
Last Updated
10 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Male

Investigators

Sponsor
Igenomix
Responsible Party
Principal Investigator
Principal Investigator

Carlos Simon

Principal Investigator; Gynecologist IVI Valencia

Instituto Valenciano de Infertilidad, IVI VALENCIA

Eligibility Criteria

Inclusion Criteria

  • azoospermic patients

Exclusion Criteria

  • Not provided

Outcomes

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.

Study Sites (1)

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