Acute Graft-versus-Host DiseaseEarly Phase 1NCT06949267
A Study of iMSC for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
A Early Phase 1 study testing iMSC and conventional aGVHD prophylaxis in people with Acute Graft-versus-Host Disease, run by Ruijin Hospital.
Trial summary
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation. Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Acute Graft-versus-Host Disease
- What is being tested?
- iMSC and conventional aGVHD prophylaxis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2025to 31 Mar 2028
- Phase
- Early Phase 1
- 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
- No gender restrictions and age between 14-70 years old；
- Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
- Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP< 0.14 at +7d, another test was performed at +14d)；
- Estimated survival≥ 24 weeks；
- Eastern Cooperative Oncology Group（ECOG）≤ 2 points and Hematopoietic Cell Transplantation Comorbidity Index (HCT-CI)≤ 3 points；
- Subjects were be treated within 5 days after enrollment；
- Informed consent and willingness to participate in the study.
Who cannot join
- Serious organ dysfunction such as organ failure after allogeneic HSCT;
- Received more than once HSCT (including autologous transplants);
- Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
- Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
- Primary malignant hematologic disease was not remission;
- Within 6 months prior to enrollment, subjects had other diseases or their physiological conditions may interfere the study results, or had life-threatening complications;
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- Those who are suffering mental or neurological illnesses, unable to express will correctly;
- Those with active malignant solid tumors within 5 years prior to participation in this study, with the exception of radically treated cervical cancer, in situ limited prostate cancer, and nonmelanoma skin cancer;
- Subjects known to be potentially allergic or highly sensitized to the cell therapy in the study protocol;
- Have participated or are participating in another clinical trial within one month prior to enrollment;
- Those who are judged by the investigator to be unsuitable for participation in this clinical trial.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.
Read the detailed description
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects.
- Conditions
- Acute Graft-versus-Host Disease
- Being tested
- iMSC, conventional aGVHD prophylaxis
- Keywords
- iMSC, III-IV aGVHD, allogeneic hematopoietic stem cell transplantation, prophylaxis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
iMSCBiological
1× 10^6/kg each time, twice a week
conventional aGVHD prophylaxisCombination product
Cyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin（ATG）
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | conventional aGVHD prophylaxis Receives: Combination Product: conventional aGVHD prophylaxis |
| Trial group | Experimental | conventional aGVHD prophylaxis + iMSC Receives: Biological: iMSC; Combination Product: conventional aGVHD prophylaxis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative incidence of degree III-IV aGvHD
Cumulative incidence of degree III-IV aGvHD at 100 days Within 100 days of first dose
Measured: Within 100 days of first dose
Secondary outcomes (3)
Cumulative Recurrence Rate (CIR)
Cumulative Recurrence Rate (CIR) at Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Measured: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Disease-free survival (DFS)
DFS at Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Measured: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Adverse Event(AE) or Serious Adverse Event(SAE)
Number of participants with treatment-related adverse events or serious adverse events as assessed by CTCAE v5.0
Measured: Day 100 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 posted29 Apr 2025
- Study start1 Jun 2025 (estimated)
- Primary completion30 Sep 2026 (estimated)
- Study completion31 Mar 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Graft-versus-Host DiseaseStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- enrolled subjects will be 1:1 randomly assigned to experimental group or control group.The control group will receive conventional aGVHD prophylaxis and the experimental group will be receive iMSC injection plus the conventional aGVHD prophylaxis
- Masking
- None (open label)
- Enrolment
- 56 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiaoxia Hu, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949267
- Sponsor's protocol ID
- RJ-BMT-GvHD-001
- Status last verified
- Mar 2025
- First submitted
- 26 Mar 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized Controlled Study of Human Induced Pluripotent Stem Cell-derived Mesenchymal Stromal Cells (iMSC) for the Prevention of Acute Graft-versus-host Disease After Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06949267
- Acronym / sponsor ID
- RJ-BMT-GvHD-001
- Conditions
- Acute Graft-versus-Host Disease
- Keywords
- iMSC, III-IV aGVHD, allogeneic hematopoietic stem cell transplantation, prophylaxis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 56 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jun 2025 (estimated)
- Primary completion
- 30 Sep 2026 (estimated)
- Study completion
- 31 Mar 2028 (estimated)
- First posted
- 29 Apr 2025 (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.
An open-label, randomized, controlled clinical trial to explore the efficacy and safety of iMSC in preventing the development of acute graft-versus-host disease of degree III-IV in patients after allogeneic hematopoietic stem cell transplantation.
Detailed description
This is an open-label, randomized, controlled study, enrolled subjects(patients at risk for aGVHD of degree III-IV after allogeneic hematopoietic stem cell transplantation) will be 1:1 randomized to experimental group or control group. Control group will receive conventional aGVHD prophylaxis and the experimental group will receive iMSC injection plus conventional aGVHD prophylaxis, with 28 cases in each group, for a total of 56 subjects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- enrolled subjects will be 1:1 randomly assigned to experimental group or control group.The control group will receive conventional aGVHD prophylaxis and the experimental group will be receive iMSC injection plus the conventional aGVHD prophylaxis
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Combination Product: conventional aGVHD prophylaxisconventional aGVHD prophylaxis |
| Trial group | Experimental | Biological: iMSC, Combination Product: conventional aGVHD prophylaxisconventional aGVHD prophylaxis + iMSC |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects with malignant or nonmalignant hematologic diseases 7-21 days after allogeneic hematopoietic stem cell transplantation;
- No gender restrictions and age between 14-70 years old；
- Patients received aGVHD prophylaxis regimen of a calcium-modulated phosphatase inhibitor combined with mycophenolate mofetil wtih or without short-course methotrexate and rabbit anti-human thymocyte globulin (CNI+MMF± short-course MTX +ATG)；
- Patients had a MAGIC algorithm probability (MAP) score ≥ 0.14 at +7d or +14d after allogeneic hematopoietic stem cell transplantation(HSCT) (if patients had a MAP< 0.14 at +7d, another test was performed at +14d)；
- Estimated survival≥ 24 weeks；
Key exclusion criteria (11 listed)
- Serious organ dysfunction such as organ failure after allogeneic HSCT;
- Received more than once HSCT (including autologous transplants);
- Positive for Hepatitis B Surface Antigen (HBsAg) or Hepatitis B Core Antibody (HBcAb) and have Hepatitis B Virus (HBV) DNA titers above the normal range ; positive for Hepatitis C Virus (HCV) antibodies and have positive peripheral blood HCV RNA; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for syphilis;
- Subjects with severe hepatic veno-occlusive disease or sinus veno-occlusive syndrome;
- Primary malignant hematologic disease was not remission;
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 |
|---|---|---|
| iMSC1× 10^6/kg each time, twice a week | Biological | Trial group |
| conventional aGVHD prophylaxisCyclosporine or tacrolimus(CNI)+Mycophenolate mofetil(MMF)± Short Course Methotrexate(MTX)+Anti-human T-lymphocyte Globulin（ATG） | Combination product | Control group, Trial group |
Primary outcome
Cumulative incidence of degree III-IV aGvHD
Time frame: Within 100 days of first dose
Cumulative incidence of degree III-IV aGvHD at 100 days Within 100 days of first dose
3 secondary outcomes
Cumulative Recurrence Rate (CIR)
Time frame: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Disease-free survival (DFS)
Time frame: Day 100, Month 6, Month 9, Month 12 , Month 18 , Month 24 after first dose
Adverse Event(AE) or Serious Adverse Event(SAE)
Time frame: Day 100 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 29 Apr 2025.
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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.
Xiaoxia Hu, MD principal investigator
Ruijin Hospital
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing iMSC and conventional aGVHD prophylaxis in people with Acute Graft-versus-Host Disease, run by Ruijin Hospital.
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 8 inclusion and 11 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: opening soon, as of the sponsor's last update on 29 Apr 2025. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Xiaoxia Hu, MD (+86 021-64370045, hu_xiaoxia@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cumulative incidence of degree III-IV aGvHD (time frame: Within 100 days of first dose). 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 29 Apr 2025.