Cord blood stem cells take on deadly transplant complication
NCT ID NCT03847844
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 Hide 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.
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- Poop pills may tame deadly transplant complication