Acute Graft Versus Host DiseasePhase 1NCT06444022
hAESCs Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
A Phase 1 study testing Human amniotic epithelial stem cells（hAESCs） in people with Acute Graft Versus Host Disease, run by Nanfang Hospital, Southern Medical University.
Trial summary
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Graft Versus Host Disease
- What is being tested?
- Human amniotic epithelial stem cells（hAESCs）
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 30 Jun 2028
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Standard risk GVHD patients with hematological malignancies older than 18 years;
- High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
- Well informed about this study and signed a consent form before the trial;
- Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
- No evidence of lung infection by X-rays examination;
- Eastern cooperative oncology group (ECOG) performance status of 0 or 1, Hematopoietic cell transplantation - specific comorbidity index (HCT-CI) of 0, 1, 2;
- Normal liver and kidney function: Serum bilirubin≤35µmol/L, AST/ALT was less than 2 times the upper limit of normal value, and serum creatinine ≤130µmol/L
Who cannot join
- Reduce pretreatment dose or secondary transplantation;
- Participate other clinical trials within 2 months before this study;
- Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
- History of severe allergic disease or is allergic to one or more drugs;
- Patients who are considered unsuitable for the study by the investigator.
About this study
Official title: Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
Read the detailed description
This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
- Conditions
- Acute Graft Versus Host Disease
- Being tested
- Human amniotic epithelial stem cells（hAESCs）, placebo (cell preservation solution)
- Keywords
- hAESCs
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Human amniotic epithelial stem cells（hAESCs）Biological
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD)
placebo (cell preservation solution)Biological
Same dose placebo (cell preservation solution) injections as control group
| Study group | Role | What they receive |
|---|---|---|
| hAESCs | Experimental | Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10^6 cell/kg. Receives: Biological: Human amniotic epithelial stem cells（hAESCs） |
| placebo (cell preservation solution) | Placebo comparator | Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT. Receives: Biological: placebo (cell preservation solution) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study.
hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE.
Measured: 1 year
Secondary outcomes (4)
Rate of acute graft-versus-host disease in patients
Occurrence and severity (grade) of Graft-versus-host disease after hAECs infusion
Measured: 1 year
Immune reconstitution 6 months before and after hematopoietic stem cell transplantation
10 days(d) before hematopoietic stem cell transplantation and 1d, 7d±2, 14d±2, 21d±2, 28d±2, 3 month(m) ± 2 days , 6 m ± 2 days, testing expression of immune cells
Measured: 6 months
Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured
The amount of cytokines in plasma was measured: TGF-b
Measured: 1 month
Incidence of CMV and EBV infection
Hematopoietic stem cell transplantation after 7 days ±2, 14 days ±2, 21 days±2, 28d±2, 2M±2 days, 3M±2 days, 6M±2 days, 12M±2 days;
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2024
- Study start1 Jun 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion30 Jun 2028 (estimated)
Why it stopped: The research content involving the use of hAESCs for the prevention of aGVHD after HSCT has completed the IND application for treating the said condition. Therefore, an application is submitted to terminate this research project.
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 Nanfang Hospital, Southern Medical UniversityThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- The study plans to recruit 18 participants who meet the criteria and is divided into two groups with 9 subjects individually. Infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanfang Hospital, Southern Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Sponsor
- Investigators
- Xiaojun Huang, Study chair, Nanfang Hospital, Southern Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06444022
- Sponsor's protocol ID
- NFEC-2019-128
- Status last verified
- Apr 2026
- First submitted
- 8 Jul 2022
- Last updated
- 16 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study of hAESCs on Prevention of Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT06444022
- Acronym / sponsor ID
- NFEC-2019-128
- Conditions
- Acute Graft Versus Host Disease
- Keywords
- hAESCs
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: The research content involving the use of hAESCs for the prevention of aGVHD after HSCT has completed the IND application for treating the said condition. Therefore, an application is submitted to terminate this research project.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Nanfang Hospital, Southern Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 30 Jun 2028 (estimated)
- First posted
- 5 Jun 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.
This is a parallel controlled clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
Detailed description
This study is a controlled trial, with 18 subjects enrolled in the experimental group or the control group. The study will consist of four phases, including screening phase, preparation phase, hAESCs treatment phase and observational follow-up period. The cell dose of the experimental group was 1x10^6 cells/kg and the control group is infused placebo (the composition was the same as hAESCs injection excipients, but did not contain hAESCs). The infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- The study plans to recruit 18 participants who meet the criteria and is divided into two groups with 9 subjects individually. Infusion of hAESCs/placebo at the day before HSCT and 7th days after HSCT.
| Arm | Type | Receives |
|---|---|---|
| hAESCs | Experimental | Biological: Human amniotic epithelial stem cells（hAESCs）Intravenous infusion of hAESCs to 9 subjects at the day before HSCT and 7th days after HSCT. The dose is 1×10^6 cell/kg. |
| placebo (cell preservation solution) | Placebo comparator | Biological: placebo (cell preservation solution)Intravenous infusion of placebo (cell preservation solution with no hAESCs) to other 9 subjects at the day before HSCT and 7th days after HSCT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Standard risk GVHD patients with hematological malignancies older than 18 years;
- High risk GVHD patients with hematological malignancies: haplotype hematopoietic stem cell transplantation patients, donor is female or more than 30 years old;
- Well informed about this study and signed a consent form before the trial;
- Left ventricular ejection fraction (LVEF) ≧ 50%, no evidence of pericardial effusion;
- No evidence of lung infection by X-rays examination;
Key exclusion criteria (5 listed)
- Reduce pretreatment dose or secondary transplantation;
- Participate other clinical trials within 2 months before this study;
- Female, 1) pregnant/nursing period, or 2) have a pregnancy plan during the study period, or 3) have fertility and cannot take effective contraception;
- History of severe allergic disease or is allergic to one or more drugs;
- Patients who are considered unsuitable for the study by the investigator.
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 |
|---|---|---|
| Human amniotic epithelial stem cells（hAESCs）Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation (hAECs-GVHD) | Biological | hAESCs |
| placebo (cell preservation solution)Same dose placebo (cell preservation solution) injections as control group | Biological | placebo (cell preservation solution) |
Primary outcome
Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE)
Time frame: 1 year
AE occurring throughout the study period will be evaluated using the CTCAE V5.0 standard. AE/SAE and AESI were evaluated after first hAESCs infusion by laboratory examination, measurement of vital signs, physical examination, and subjects' symptoms to detect new abnormalities and/or deterioration of previous conditions and evaluate the safety of the study. hAESCs intravenous infusion is followed up and monitored closely, mainly including vital signs, physical examination, ECOG, electrocardiogram, blood biochemistry, blood RT, urine RT, coagulation laboratory test, imaging examination, type, frequency and severity of AE.
4 secondary outcomes
Rate of acute graft-versus-host disease in patients
Time frame: 1 year
Immune reconstitution 6 months before and after hematopoietic stem cell transplantation
Time frame: 6 months
Hematopoietic stem cell transplantation was performed 10 days before and 1 d, 7 d ±2, 14 d ±2, 21 d±2, 28 d ±2 after transplantation The amount of cytokines in plasma was measured
Time frame: 1 month
Incidence of CMV and EBV infection
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 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. This study is not recruiting at the moment.
Xiaojun Huang study chair
Nanfang Hospital, Southern Medical University
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Human amniotic epithelial stem cells（hAESCs） in people with Acute Graft Versus Host Disease, run by Nanfang Hospital, Southern Medical University.
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 7 inclusion and 5 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: withdrawn, as of the sponsor's last update on 16 Apr 2026. 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. Some participants in this study may receive a placebo. 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Follow up closely after intravenous hAESCs therapy to monitor Adverse Event/Serious Adverse Event(AE/SAE) (time frame: 1 year). 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 16 Apr 2026.