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Could a Man's own stem cells restore his fertility?

NCT ID NCT02641769

Disease control Sponsor: Stem Cells Arabia Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 01, 2026 · Last updated Jul 02, 2026 · Updated 1 time

Summary

This trial tests whether injecting a man's own purified stem cells into his testicles can restart sperm production. It is for men with non-obstructive azoospermia, a condition where the testicles produce little or no sperm. The stem cells are taken from the patient's bone marrow, purified, and then injected directly into the seminiferous tubules. The study will follow participants for 24 months to check for sperm in semen or testicular tissue and to monitor safety.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
autologous bone marrow-derived stem cells (spermatogonial and mesenchymal)
What this could lead to
If successful, this approach could help men with certain types of infertility produce their own sperm, potentially enabling biological fatherhood without donor sperm.
What could go wrong
This is an early-phase study (Phase 1/2) with 600 participants, so results are not yet proven. Risks include infection, bleeding, or failure to produce viable sperm.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jan 2014

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 50 years

Sex

Male participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Infertile males with confirmed diagnosis of non-obstructive azoospermia (NOA) Exclusion Criteria: * 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….)

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Conditions

The condition(s) this trial relates to.

azoospermia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Non-obstructive azoospermia

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Stem Cells of Arabia

    RECRUITING

    Amman, Amman Governorate, 11953, Jordan

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