Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Stem cell reset could open door to kidney transplants for 'Impossible' patients

NCT ID NCT07607197

Disease control Sponsor: Hospital Universitari Vall d'Hebron Research Institute 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 2 times

Summary

This early-phase trial tests whether a powerful immune reset using a patient's own stem cells can clear the antibodies that block them from receiving a kidney transplant. Ten highly sensitized adults with end-stage kidney disease will undergo intense conditioning to wipe out their immune memory, then receive their own purified stem cells to rebuild a naive immune system. The goal is to lower antibody levels enough to allow a compatible deceased-donor kidney transplant.

What this could mean

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

Active substance
Autologous hematopoietic stem cell transplantation (AHSCT) with conditioning drugs (rituximab, cyclophosphamide, thymoglobulin)
What this could lead to
If it works, this could allow highly sensitized patients to receive a compatible kidney transplant, reducing time on dialysis.
What could go wrong
This is a very early, small trial (10 people) testing an intense procedure with significant risks like infection and organ damage. The immune reset may not last or enable 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

About 10 people

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

Started

Feb 2024

Expected to finish

Jun 2028

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

18 to 60 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: * Patients aged between 18 and 60 years. * Diagnosis of end-stage kidney disease (ESRD) currently maintained on chronic dialysis. * Highly sensitized/hyperimmunized status, defined by a high calculated Panel Reactive Antibody (cPRA) level (e.g., \>= 95%). * Active status on the deceased-donor kidney transplant waiting list. * Adequate bone marrow, hepatic, cardiac, and pulmonary function to safely undergo the conditioning regimen and AHSCT. * Capable of understanding the study requirements and providing written informed consent. Exclusion Criteria: * Contraindications to the conditioning regimen medications (rituximab, cyclophosphamide, or rATG). * Active, uncontrolled systemic infection, or chronic active infection (including HIV, active Hepatitis B or C, or active tuberculosis). * Significant cardiac dysfunction (e.g., Left Ventricular Ejection Fraction \< 50%) or severe underlying pulmonary disease. * History of malignant neoplasm within the past 5 years, excluding successfully treated non-melanoma skin cancer or carcinoma in situ. * Previous autologous or allogeneic hematopoietic stem cell transplantation. * Pregnancy or breastfeeding. * Any psychiatric, medical, or geographical condition that, in the investigator's opinion, prevents compliance with the protocol and long-term follow-up.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Alloimmunization are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

anti-HLA hyperimmunization chronic kidney disease chronic renal failure syndrome end stage renal failure

As listed by the trial registrant

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

Alloimmunization End stage cronic kidney disease Highly sensitized patients awaiting kidney transplant HLA sensitization Kidney failure, chronic Kidney transplantation

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

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, Catalonia, 08035, Spain

More trials for these conditions

Other studies related to the condition(s) this trial covers.