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Placenta cell therapy shows promise for tough transplant complication

NCT ID NCT04118556

Disease control Sponsor: Mats Remberger 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
The trial has finished. Results may not be published yet.
Stopped early This study
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This status has not been confirmed recently, so it may be out of date.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 trial tested a treatment made from placenta cells (called decidua stroma cells) in 12 adults who had severe graft-versus-host disease (GVHD) after a stem cell transplant and did not respond to steroids. Patients received two doses of the cells or the best available standard therapy. The goal was to see if the cell treatment was safe and could improve outcomes by day 56.

What this could mean

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

Active substance
placenta-derived decidua stroma cells (DSC)
What this could lead to
If it works, this could offer a new treatment option for patients with severe graft-versus-host disease that does not respond to steroids.
What could go wrong
This is a small, early-phase trial (only 12 patients) that was terminated, so results are limited. The treatment may not work better than existing options and carries risks like infection or infusion reactions.

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

12 people

The number who actually took part.

Started

Dec 2021

Finished

Apr 2026

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 years and older

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: 1. Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT. 2. Signed written study informed consent once SR-aGvHD is confirmed. Exclusion Criteria: 1. Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment. 2. Has received systemic treatment for aGvHD apart from steroids. 3. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome. 4. Pregnant or lactating women. 5. Significant respiratory disease. 6. Presence of severely impaired renal function 7. Any corticosteroid therapy for indications other than aGvHD 8. Previous participation in a study of any investigational treatment agent within 30 days 9. Known human immunodeficiency virus infection (HIV). 10. Patients suffering on active tuberculosis or viral hepatitis 11. Significant respiratory disease 12. Presence of severely impaired renal or liver function 13. History of progressive multifocal leuko-encephalopathy 14. Patients with coagulopathy 15. History of severe chronic history of heart disease 16. Any condition that would, in the Investigator's judgment, interfere with full participation in the study.

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Conditions

The condition(s) this trial relates to.

acute graft versus host disease graft versus host disease

As listed by the trial registrant

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

GVHD, acute

Contacts and locations

Locations

  • Copenhagen Univerity Hospital

    Copenhagen, 2300, Denmark

  • Lund University Hospital

    Lund, SE-221 85, Sweden

  • Oslo University Hospital

    Oslo, NO-0424, Norway

  • Uppsala University Hospital

    Uppsala, SE-75185, Sweden

More trials for these conditions

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