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Cord blood stem cells take on deadly transplant complication

NCT ID NCT03847844

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested whether stem cells from donated umbilical cords (Cyto-MSC) could help treat acute graft-versus-host disease (GVHD), a serious complication after bone marrow transplants. Twenty-six patients with moderate to severe GVHD received the stem cells plus standard steroids. The goal was to see if this combination could improve response rates and survival. The trial was completed, but results are not yet widely reported.

What this could mean

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

Active substance
umbilical cord mesenchymal stem cells (Cyto-MSC)
What this could lead to
If it works, this could provide a new front-line treatment option for acute graft-versus-host disease, potentially improving survival and reducing complications.
What could go wrong
This is an early-phase trial with only 26 participants, so results may not apply to all patients. Stem cell therapies can carry risks like infection or immune 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 1/2

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

Participants

26 people

The number who actually took part.

Started

Feb 2019

Finished

Aug 2023

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

16 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: * Patient age 16 and above * Patient who has undergone an allogeneic haematopoietic stem cell transplantation (HSCT) receiving allograft either from HLA-matched related donor (MRD), HLA-matched unrelated donor (MUD), Unrelated Cord Blood (UCB) or Haploidentical donor and developed grade II-IV acute graft versus host disease (acute GVHD) involving the skin, GI tract and/or liver based on 1994 Consensus Conference on Acute GVHD Grading * Patient and/or parent(s) or legal guardian(s) and assent form signed informed consent. Assent form will be obtained for patients aged less than 18 years. Investigators will obtain the permission of the parents or guardians for the participation of the minor in the research, and to solicit assent from the minor Exclusion Criteria: * Patient who has enrolled in another investigational drug trial or stem cell related trial or has completed the aforesaid within (3) months * Patient with HIV or syphilis (Patient should be screened for HIV and VDRL up to 6 months prior to study start) * Patient with Hepatitis B (HBV) or Hepatitis C (HCV). All patients must be screened for HBV and HCV up to 6 months prior to study start using the routine hepatitis virus laboratory. Patients who are positive for HBsAg or HBcAb will be eligible if they are negative for HBV-DNA, these patients should receive prophylactic antiviral therapy. Patients who are positive for anti-HCV antibody will be eligible if they are negative for HCV-RNA * Patient has creatinine clearance of ≤50mL/min or creatinine is ≥200 µmol/L * Patient had undergone or on other immune-modulatory treatments such as interferon or Thalidomide over the last 12 months * Patient with progressive underlying disease or not in complete remission (CR) at the time of transplant * Any other severe co-morbidities which the doctor deems as a contraindication to cell therapy * Adults under law protection or without ability to consent * The patient has previous history or on-going psychiatric illness * Patient has received an HSCT transplant for a solid tumor disease * Patient has a known hypersensitivity to dimethyl sulfoxide (DMSO) * Patient is a female who is pregnant, lactating, or is planning a pregnancy during study participation, or in the follow-up period

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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.

Contacts and locations

Locations

  • Hospital Ampang

    Ampang, Selangor, 68000, Malaysia

More trials for these conditions

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