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

NCT02641769 | Unknown Phase 1

• 1 other identifier: SCA-INF1
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Non-obstructive Azoospermia

Outcome Measures

Primary Outcomes (1)

• Appearance of different germ cells in testicles through the progress of spermatogenesis will be assessed by the count of cells using histological studies.

  12 months

Secondary Outcomes (2)

• General improvements of testicular morphology will be assessed with histological studies.

  12 months

• Improvement in sexual function will be assessed using a questionnaire

  12 months

Study Arms (1)

Stem Cell Transplantation

OTHER

intervention with transplantation of autologous purified stem cells

Biological: Stem Cell Transplantation

Interventions

Stem Cell Transplantation BIOLOGICAL

intervention with transplantation of autologous purified stem cells

Stem Cell Transplantation

Eligibility Criteria

• Age: 21 Years - 50 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Infertile males with confirmed diagnosis of non-obstructive azoospermia (NOA)

You may not qualify if:

• Patients with Obstructive Azoospermia (OA)
• Previous surgical history in Testis
• Patients with infectious genital diseases
• Patients with anatomical abnormalities of the genital tract
• Patients with major medical problems as malignancies
• Chromosomal aberration (e.g. Y microdeletion, trisomy….)

Sponsors & Collaborators

• Stem Cells Arabia: lead

Study Sites (1)

Stem Cells of Arabia

Amman, 11953, Jordan

RECRUITING

MeSH Terms

Interventions

Stem Cell Transplantation

Intervention Hierarchy (Ancestors)

Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Study Officials

• Adeeb AlZoubi, PhD

  Stem Cells of Arabia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adeeb AlZoubi, PhD

CONTACT

00962795337575; adeebalzoubi@stemcellsarabia.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2015
• First Posted: December 29, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2020
• Study Completion: January 1, 2021
• Last Updated: March 17, 2020

Record last verified: 2020-03

Locations

JO (1)