Lab-Grown cells offer hope for transplant complication
NCT ID NCT06321198
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a new treatment made from special stem cells (iMSC) for people with a serious complication after bone marrow transplant called graft-versus-host disease that does not respond to steroids. The treatment aims to control the disease by calming the immune system. About 12 participants aged 4 to 70 will receive the cells to see if it is safe and helps improve their condition.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 12 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Feb 2024
- Expected to finish
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Mar 2027
An estimate. End dates often move.
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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4 to 70 years
- Sex
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Anyone
- Healthy volunteers
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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: 1.Subjects who understand and voluntarily sign the Informed Consent Form(ICF); 2.4-70 years; 3.Subjects with SR-aGVHD; 4.ECOG≤2; 5.Subjects with II to IV grades of steroid hormone resistance; Exclusion Criteria: 1. Accepted systemic or local treatment of mesenchymal stem cells; 2. Have severe allergy to blood products or have allergy history of heterologous protein; 3. Expected survival period within 3 months; 4. Alanine transaminase(ALT)or Aspartate aminotransferase(AST)\>2\*upper limit of normal(ULN);Creatinine clearance rate≤30ml/min or Blood Urea Nitrogen(BUN)\>2\*upper limit of normal(ULN), International Normalized Ratio (INR)\>1.5\*upper limit of normal(ULN); 5. Have severe hepatic veno-occlusive disease(HVOD); 6. Have severe lung disease like severe lung infection; 7. Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure; 8. Proved having resistant hypertension within 6 months before enrollment; 9. Have active thrombus; 10. Have untreated or uncertain active solid tumors within 5 years; 11. Have alcohol or drug addiction or with a clear history of mental disorders or with a history of drug abuse or drug use of psychotropic substances; 12. Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive; 13. Have active hepatitis B or hepatitis C; 14. Have gastrointestinal symptoms which not caused by GVHD 15. Pregnant or lactating female subjects, or subjects who are unable to comply with contraceptives from the study period to 6 months after the end of this study; 16. Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening; 17. Not suitable for this clinical trial for other reasons.
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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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Anhui Provincial Hospital
RECRUITINGHefei, Anhui, 230036, China
More trials for these conditions
Other studies related to the condition(s) this trial covers.