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Obtaining Undifferentiated Cells From Testis Biopsy

This study has been completed.
Sponsor:
Information provided by:
Instituto Valenciano de Infertilidad, Spain
ClinicalTrials.gov Identifier:
NCT01375062
First received: June 7, 2011
Last updated: September 8, 2011
Last verified: September 2011
History of Changes
  Purpose

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


Condition Intervention
Azoospermia
 Other: analyse and proliferate the cells

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Isolation, Culture and Characterization Stem Cells From Testis Biopsy

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Instituto Valenciano de Infertilidad, Spain:

Primary Outcome Measures:
  • 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.



Estimated Enrollment: 50
Study Start Date: May 2009
Study Completion Date: July 2011
Primary Completion Date: July 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: tissue from biopsies 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.

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).

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

-azoospermic patients

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01375062

Locations
Spain
IVI Valencia
Valencia, Spain, 46015
Sponsors and Collaborators
Instituto Valenciano de Infertilidad, Spain
Investigators
Study Director: Carlos Simon, MDPhD IVI Valencia
Principal Investigator: Marcia Riboldi, PhD Fundación IVI
  More Information

No publications provided

Responsible Party: Dr. Carlos Simón, IVI Valencia
ClinicalTrials.gov Identifier: NCT01375062     History of Changes
Other Study ID Numbers: 0902-057-F-CS
Study First Received: June 7, 2011
Last Updated: September 8, 2011
Health Authority: Spain: Ministry of Health

Additional relevant MeSH terms:
Azoospermia
Infertility, Male
Infertility
Genital Diseases, Male

ClinicalTrials.gov processed this record on May 23, 2013