Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)NCT06321198
A Trial to Evaluate the Safety and Preliminary Efficacy of iMesenchymal Stromal Cells(iMSC) in Subjects With SR-aGVHD
A study testing iMSC in people with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD), run by Anhui Provincial Hospital at 1 site in China.
Trial summary
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD Read more about this study
- Who is it for?
- Ages 4 to 70 years
- Conditions the study is for
- Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)
- What is being tested?
- iMSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 10 Feb 2024to 2 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- Accepted systemic or local treatment of mesenchymal stem cells;
- Have severe allergy to blood products or have allergy history of heterologous protein;
- Expected survival period within 3 months;
- 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);
- Have severe hepatic veno-occlusive disease(HVOD);
- Have severe lung disease like severe lung infection;
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- Have history of severe acute myocardial infarction or have uncontrolled angina pectoris,arrhythmia and severe heart failure;
- Proved having resistant hypertension within 6 months before enrollment;
- Have active thrombus;
- Have untreated or uncertain active solid tumors within 5 years;
- 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;
- Human immunodeficiency virus(HIV)antibody positive, treponema pallidum (TP) antibody positive;
- Have active hepatitis B or hepatitis C;
- Have gastrointestinal symptoms which not caused by GVHD
- 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;
- Subjects who have participated in other clinical trials and have used other study products within 12 weeks before screening;
- Not suitable for this clinical trial for other reasons.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Anhui Provincial Hospital
Hefei, Anhui, 230036
Zhu Xiaoyu, Ph.D, +86 15255456091, xiaoyuz@ustc.edu.cn
Sun Guangyu, +86 13956970687, sunguangyu_vip@foxmail.com
About this study
Official title: A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Read the detailed description
A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD
- Being tested
- iMSC
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMSCBiological
Subjects will receive 4 or more times of iMSC injection
| Study group | Role | What they receive |
|---|---|---|
| iMSC injection | Experimental | Low dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week; Receives: Biological: iMSC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose-Limiting Toxicity(DLT)
Number of Dose-limiting toxicity in 28 days after injection
Measured: 4 weeks after initial infusion
Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0
Measured: From the date of initial infusion to 180 days after initial infusion
Secondary outcomes (2)
Objective Response Rate(ORR)
Percentage of participants achieved Complete Response(CR) or Partial Response(PR)
Measured: 28 days after initial infusion
Overall Survival(OS)
The time from initial infusion to death
Measured: 100 days after initial infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2024
- Study start10 Feb 2024
- Primary completion2 Mar 2027 (estimated)
- Study completion2 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD)Studies of the same condition, open and under way.
- More trials run by Anhui Provincial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Provincial Hospital
- Sponsor type
- Other government
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
- Responsible party
- Principal investigator, Xiaoyu Zhu, Anhui Provincial Hospital
- Investigators
- Xiaoyu Zhu, PH.D, Principal investigator, Anhui Provincial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06321198
- Sponsor's protocol ID
- iMSC-2001
- Status last verified
- Mar 2026
- First submitted
- 13 Mar 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Trial to Evaluate the Safety and Preliminary Efficacy of Human Induced Pluripotent Stem Cell Derived Mesenchymal Stromal Cells in Subjects With Steroid-refractory Acute Graft-Versus-Host Disease
- ClinicalTrials.gov ID
- NCT06321198
- Acronym / sponsor ID
- iMSC-2001
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Anhui Provincial HospitalOther government
- Collaborators
- Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences (IHCAMS)
- Study start
- 10 Feb 2024 (actual)
- Primary completion
- 2 Mar 2027 (estimated)
- Study completion
- 2 Mar 2027 (estimated)
- First posted
- 20 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A study to evaluate the safety and preliminary efficacy of iMSC in subjects with SR-aGVHD
Detailed description
A multiple centers, open label, dose escalation study to evaluate the safety,tolerability and preliminary efficacy of iMSC in subjects with SR-aGVHD
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| iMSC injection | Experimental | Biological: iMSCLow dose injection once a week; Low dose injection twice a week; High dose injection once a week; High dose injection twice a week; |
Who may qualify
- Ages
- 4 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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;
Key exclusion criteria (17 listed)
- Accepted systemic or local treatment of mesenchymal stem cells;
- Have severe allergy to blood products or have allergy history of heterologous protein;
- Expected survival period within 3 months;
- 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);
- Have severe hepatic veno-occlusive disease(HVOD);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| iMSCSubjects will receive 4 or more times of iMSC injection | Biological | iMSC injection |
Primary outcome
Dose-Limiting Toxicity(DLT)
Time frame: 4 weeks after initial infusion
Number of Dose-limiting toxicity in 28 days after injection
Adverse Event(AE),Serious Adverse Event(SAE),Treatment Emergent Adverse Event(TEAE)and Treatment Related Adverse Event(TRAE)
Time frame: From the date of initial infusion to 180 days after initial infusion
Number of treatment-related adverse events,treatment emergent adverse event,treatment related adverse event or serious adverse events as assessed by CTCAE v5.0
2 secondary outcomes
Objective Response Rate(ORR)
Time frame: 28 days after initial infusion
Overall Survival(OS)
Time frame: 100 days after initial infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Xiaoyu Zhu, PH.D principal investigator
Anhui Provincial Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing iMSC in people with Steroid-refractory Acute Graft-versus-host Disease(SR-aGVHD), run by Anhui Provincial Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xiaoyu Zhu, phd (+86 15255456091, xiaoyuz@ustc.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose-Limiting Toxicity(DLT) (time frame: 4 weeks after initial infusion). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.