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Selective cell removal may tame stem cell Transplant's dangerous side effect

NCT ID NCT07660783

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tests whether removing a specific type of immune cell (naive T cells) from a donor's stem cell graft can prevent graft-versus-host disease (GVHD), a serious complication where donor cells attack the recipient's body. The trial enrolls people with non-malignant blood disorders such as bone marrow failure, sickle cell disease, or immune deficiencies who need a stem cell transplant. Participants receive chemotherapy and low-dose radiation before the specially processed donor stem cells are infused.

What this could mean

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

Active substance
CD34-enriched, CD45RA-depleted donor stem cells
What this could lead to
If successful, this approach could reduce severe graft-versus-host disease after stem cell transplant for non-malignant blood disorders, improving safety and quality of life.
What could go wrong
This is a small, early-phase trial. The special graft may not prevent GVHD as hoped, and risks like infection or graft failure remain.

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 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

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

Expected to start

Sep 2026

An estimate. Start dates often move.

Expected to finish

Sep 2035

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

6 months to 50 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: * Considered appropriate candidate for allogeneic HCT following low dose (4Gy) TBI containing-conditioning and have one of the following diagnoses: A) BMF B)Hemoglobinopathies C)PID D) Autoimmune cytopenias E) Immune dysregulation F) HLH G) Other NMD treatable by HCT and NMD that is not clearly defined (a patient with a NMD for whom genetic testing has been done and a genetic mutation responsible for their NMD phenotype has not been identified) are eligible for the study following discussion with and approval by the protocol PI * Patients aged 6 months- 5 years old (inclusive) at the time of informed consent * Patient with suitable HCT donor (see inclusion criteria below) * Recipient informed consent/assent (13 years and older), and/or legal guardian permission must be obtained Exclusion Criteria: * Patient with aplastic anemia * Patients with severe combined immunodeficiency (SCID) * Fanconi anemia * Dyskeratosis congenita * Patient weight \> 100 kg * Patients who are positive for HIV-1, HIV-2 * Patients with current neoplastic disorders * Patients with uncontrolled infections for whom HCT is considered contraindicated by the consulting infectious disease physician. * Patients with organ dysfunction including A) Renal insufficiency B) Impaired cardiac function C)Impaired pulmonary function D) Liver dysfunction * Patients who are pregnant or breast-feeding * Patients on other experimental protocols for prevention of GVHD * Patients of childbearing age who are presumed to be fertile and are unwilling to use an effective birth control method or refrain from sexual intercourse during and for 12 months post-HCT * Patients with any other significant medical conditions that would make them unsuitable for transplantation, as determined by the PI * Patients with a known hypersensitivity to tacrolimus or MMF

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

How to take part

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

  1. The places running it

    2 sites. 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

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109, United States

  • Seattle Children's Hospital

    Seattle, Washington, 98105, United States

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