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Bubble baby breakthrough? experimental cell shot aims to reboot immune system faster

NCT ID NCT03879876

Disease control Sponsor: Assistance Publique - Hôpitaux de Paris Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This early-phase trial tested whether injecting special immune-building cells (HTLPs) could help children with severe combined immunodeficiency (SCID) rebuild their immune system faster after a partially matched stem cell transplant. Only 4 children took part. The goal was to see if the injection was safe and if it led to quicker recovery of T-cells, which fight infections.

What this could mean

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

Active substance
Human T Lymphoid Progenitor (HTLP) injection
What this could lead to
If it works, this could help children with SCID rebuild their immune system faster after a stem cell transplant, reducing infection risk.
What could go wrong
This was a very small, early-phase trial with only 4 patients. The approach is still experimental and may not work for everyone. Risks include side effects from the injection or transplant.

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

4 people

The number who actually took part.

Started

May 2020

Finished

Apr 2024

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

2 to 18 years

Sex

Anyone

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: * Pediatric patients affected by any type of SCID confirmed by clinical, immunological and/or molecular diagnosis and eligible for an allogeneic HSCT * Absence of a matched sibling donor or a matched unrelated donor (MUD) 10/10 * Clinical conditions incompatible with the search of a MUD * Written, informed consent of parents/ legal representative (child) * Age ≤ 2 years at the time of screening * No prior therapy with allogeneic stem cell transplantation * No treatment with another investigational drug within one month before inclusion * Patient affiliated to social security Exclusion Criteria: * Presence of an HLA genoidentical donor * Absence of written parental consent * Treatment with another investigational drug within one month before inclusion * Positive for HIV infection by genome PCR * Contra-indication to allogeneic transplantation or conditioning therapy (except SCID patients with DNA repair deficiency)

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Conditions

The condition(s) this trial relates to.

severe combined immunodeficiency

As listed by the trial registrant

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

Any type of severe combined immunodeficiency (SCID) Partial HLA incompatible allogeneic hematopoietic stem cell transplantation (HSCT) Pediatric patients

Contacts and locations

Locations

  • Unité d'Immunologie Hématologie Rhumatologie Pédiatrique (UIHR),

    Paris, Île-de-France Region, 75015, France

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