Ignite Creation Date:
2024-05-06 @ 8:01 AM
Last Modification Date:
2024-10-26 @ 11:54 AM
Study NCT ID:
NCT02641769
Status:
UNKNOWN
Last Update Posted:
2020-03-17
First Post:
2015-12-07
Brief Title:
Intra-Testicular Transplantation of Autologous Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility
Sponsor:
Stem Cells Arabia
Organization:
Stem Cells Arabia
Study Overview
Official Title:
Intra-Testicular Transplantation of Purified Autologous Clusters of Differentiation CD 34133 and Mesenchymal Stem Cells for Treatment of Non-Obstructive Azoospermia Male Infertility
Status:
UNKNOWN
Status Verified Date:
2020-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed Description:
Non-obstructive azoospermia NOA is generally considered a non-medically manageable cause of male infertility These patients who constitute up to 10 of all infertile men have abnormal spermatogenesis as the cause of their azoospermia The etiology affecting approximately 60 of azoospermic men includes non-obstructive causes of azoospermia including toxic exposures or abnormal testicular development NOA results from either primary testicular failure elevated Luteinizing Hormone LH Follicle stimulating hormone FSH small testes affecting up to 10 of men presenting with infertility secondary testicular failure congenital hypogonadotropic hypogonadism with decreased LH and FSH small testes or incomplete or ambiguous testicular failure either increased FSH and normal volume testes normal FSH and small testes or normal FSH and normal testis volume Prior to microsurgical testicular sperm retrieval techniques and IVFICSI donor insemination was the only option available to men with NOA The establishment of in vitro fertilization using intracytoplasmic sperm injection ICSI as a standard treatment modality has resulted in a number of these men successfully fathering a child through surgically retrieved sperm from the testis The challenge however is to improve their spermatogenic function to enable the appearance of sperm in their ejaculate or to improve the chances of a successful retrieval from the testis for ICSI
The initial evaluation aims at resolving the following issues 1 confirming azoospermia 2 differentiating obstructive from non-obstructive etiology 3 assessing for the presence of reversible factors and 4 evaluating for the presence of genetic abnormalities An elevated follicle-stimulating hormone FSH level or an absence of normal spermatogenesis by testicular histology in the presence of azoospermia is generally considered sufficient evidence of a non-obstructive etiology The most common reversible factors that need to be ruled out include recent exogenous hormone administration severe febrile illnesses chemotherapyradiation or prolonged antibiotic use
During past few years a considerable progress in the derivation of male germ cells from pluripotent stem cells has been made These studies provide a desirable experimental model for elucidating underlying molecular mechanism of male germ cell development and potential strategies for producing haploid germ cells for the treatment of male infertility Spermatogenesis is a complex process by which spermatogonial stem cells SSC self-renew and differentiate into haploid spermatozoa In mammals this process takes place in the seminiferous tubules of testis which provide a functional niche for male germ cells and involve three major stages mitosis meiosis and spermiogenesis Errors at any stage of spermatogenesis can result in subfertility and infertility
Researchers are currently developing alternative treatment options for these men involving stem cells It has been verified that mouse induced pluripotent stem cells iPSCs can form functional spermatozoa Functional assays have shown that spermatozoa generated from iPSCs were capable of fertilizing the oocytes after intracytoplasmatic injection and giving rise to fertile offspring following embryo transfer So far functional male gametes from human iPSCs have not been obtained
There are two possible approaches in generating of male germ cells from pluripotent stem cells in vitro differentiation into advanced haploid cell products or combined in vitro differentiation and in vivo transplantation However the originality of this study is illustrated in the transplantation of purified autologous CD34CD133 and mesenchymal bone marrow stem cells BMSCs into infertile patients without in vitro breeding culture or manipulation thus avoiding in vitro cell propagation risks as genetic mutations and DNA changes The cells are withdrawn and injected back into the patient on the very same day of the procedure hence conferring the highest safety and efficacy parameters
The initial evaluation aims at resolving the following issues 1 confirming azoospermia 2 differentiating obstructive from non-obstructive etiology 3 assessing for the presence of reversible factors and 4 evaluating for the presence of genetic abnormalities An elevated follicle-stimulating hormone FSH level or an absence of normal spermatogenesis by testicular histology in the presence of azoospermia is generally considered sufficient evidence of a non-obstructive etiology The most common reversible factors that need to be ruled out include recent exogenous hormone administration severe febrile illnesses chemotherapyradiation or prolonged antibiotic use
During past few years a considerable progress in the derivation of male germ cells from pluripotent stem cells has been made These studies provide a desirable experimental model for elucidating underlying molecular mechanism of male germ cell development and potential strategies for producing haploid germ cells for the treatment of male infertility Spermatogenesis is a complex process by which spermatogonial stem cells SSC self-renew and differentiate into haploid spermatozoa In mammals this process takes place in the seminiferous tubules of testis which provide a functional niche for male germ cells and involve three major stages mitosis meiosis and spermiogenesis Errors at any stage of spermatogenesis can result in subfertility and infertility
Researchers are currently developing alternative treatment options for these men involving stem cells It has been verified that mouse induced pluripotent stem cells iPSCs can form functional spermatozoa Functional assays have shown that spermatozoa generated from iPSCs were capable of fertilizing the oocytes after intracytoplasmatic injection and giving rise to fertile offspring following embryo transfer So far functional male gametes from human iPSCs have not been obtained
There are two possible approaches in generating of male germ cells from pluripotent stem cells in vitro differentiation into advanced haploid cell products or combined in vitro differentiation and in vivo transplantation However the originality of this study is illustrated in the transplantation of purified autologous CD34CD133 and mesenchymal bone marrow stem cells BMSCs into infertile patients without in vitro breeding culture or manipulation thus avoiding in vitro cell propagation risks as genetic mutations and DNA changes The cells are withdrawn and injected back into the patient on the very same day of the procedure hence conferring the highest safety and efficacy parameters
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None