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Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility.

NCT02641769 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 50

Last updated 2020-03-17

No results posted yet for this study

Summary

This is an open label, single arm, single center investigation to assess the safety and efficacy of purified adult autologous bone marrow derived CD34+, CD133+, and mesenchymal stem cells injected into the seminiferous tubules and testis, through a 12 week follow-up period. The investigators' selected model of research is based on maximizing the efficiency of the approach by choosing an autologous pattern which preserves the genetic make-up of an individual that is vital in infertility conditions. Additionally the approach involves injecting a combination of different but purified cell types which all aid in the retrieval of spermatogenesis, and the generation of mature spermatozoa. Expected outcomes of this study are defined in general improvements in infertile patients in regards of testicular morphology, sexual function, semen quality, development of primary or secondary spermatocytes, spermatids, or mature spermatozoa in the testis, seminiferous tubules, or semen.

Conditions

  • Non-obstructive Azoospermia

Interventions

BIOLOGICAL

Stem Cell Transplantation

intervention with transplantation of autologous purified stem cells

Sponsors & Collaborators

  • Stem Cells Arabia

    lead OTHER

Principal Investigators

  • Adeeb AlZoubi, PhD · Stem Cells of Arabia

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
21 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2020-06-30
Completion
2021-01-31

Countries

  • Jordan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02641769 on ClinicalTrials.gov