Acute-graft-versus-host DiseasehAECs-GVHDNCT03764228
Human Amniotic Epithelial Cells Prevent Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
A study testing hAECs in people with Acute-graft-versus-host Disease, run by Peking University People's Hospital at 2 sites in China.
Trial summary
This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT. Read more about this study
- Who is it for?
- Ages 8 to 70 years
- Conditions the study is for
- Acute-graft-versus-host Disease
- What is being tested?
- hAECs
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesChina
- Study dates
- 1 Jul 2020to 1 Jul 2022
- Phase
- Interventional
- 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 8 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Standard risk GVHD patients with hematological malignancies;
- 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;
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.
Trial locations and contacts
2 sites in 1 country.
China2 sites, 2 recruiting
- Recruiting
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Zhao Xiangyu, +861088325949, xyz80421@126.com
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Xiang-Yu Zhao, M.D., PhD, 8610-88325949, zhao_xy@bjmu.edu.cn
About this study
Official title: Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
This is a Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
Read the detailed description
A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.
- Conditions
- Acute-graft-versus-host Disease
- Being tested
- hAECs
- Keywords
- human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hAECsBiological
Human amniotic epithelial cells（hAECs）
| Study group | Role | What they receive |
|---|---|---|
| hAECs | Experimental | Infusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10^6, 2×10^6, 5×10^6 cell/kg, successively. Receives: Biological: hAECs |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of adverse events
Safety of HSCT combined with hAECs infusion;
Measured: 1 year
Secondary outcomes (1)
GVHD
Occurrence of Graft-versus-host disease after hAECs infusion
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 Dec 2018
- Study start1 Jul 2020
- Primary completion1 Jul 2021 (estimated)
- Study completion1 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute-graft-versus-host DiseaseStudies of the same condition, open and under way.
- More trials run by Peking University People's 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking University People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Responsible party
- Principal investigator, Xiaojun Huang,MD, Peking University People's Hospital
- Investigators
- Xiaojun Huang, Principal investigator, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03764228
- Sponsor's protocol ID
- 2018PHD006-01
- Acronym
- hAECs-GVHD
- Status last verified
- Sep 2020
- First submitted
- 29 Nov 2018
- Last updated
- 1 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Yang PJ, Zhao XY, Kou YH, Liu J, Ren XY, Zhang YY, Wang ZD, Ge Z, Yuan WX, Qiu C, Tan B, Liu Q, Shi YN, Jiang YQ, Qiu C, Guo LH, Li JY, Huang XJ, Yu LY. Human amniotic epithelial stem cell is a cell therapy candidate for preventing acute graft-versus-host disease. Acta Pharmacol Sin. 2024 Nov;45(11):2339-2353. doi: 10.1038/s41401-024-01283-y. Epub 2024 May 27.
PubMed 38802569
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Arm Clinical Study of Human Amniotic Epithelial Cells in Preventing Acute Graft-versus-host Disease After Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03764228
- Acronym / sponsor ID
- hAECs-GVHD / 2018PHD006-01
- Conditions
- Acute-graft-versus-host Disease
- Keywords
- human amniotic epithelial cells(hAECs), Acute-graft-versus-host disease（aGVHD）
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 27 participants (estimated)
- Lead sponsor
- Peking University People's HospitalUniversity, hospital or other
- Collaborators
- Shanghai iCELL Biotechnology Co., Ltd, Shanghai, China
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Jul 2021 (estimated)
- Study completion
- 1 Jul 2022 (estimated)
- First posted
- 5 Dec 2018 (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 Single arm clinical study evaluating the safety and efficacy of hAECs in preventing aGVHD after HSCT.
Detailed description
A dose escalation study evaluating the safety and efficacy of human amniotic epithelial cells( hAECs) in preventing acute graft-versus-host(aGVHD) disease after hematopoietic stem cell transplantation(HSCT). The doses were 1×10^6、2×10^6、5×^6 cell/kg, successively.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| hAECs | Experimental | Biological: hAECsInfusion of hAECs at the day before HSCT and 7th days after HSCT. The dose is 1×10^6, 2×10^6, 5×10^6 cell/kg, successively. |
Who may qualify
- Ages
- 8 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- Standard risk GVHD patients with hematological malignancies;
- 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 |
|---|---|---|
| hAECsHuman amniotic epithelial cells（hAECs） | Biological | hAECs |
Primary outcome
Occurrence of adverse events
Time frame: 1 year
Safety of HSCT combined with hAECs infusion;
1 secondary outcome
GVHD
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2020.
- Derived from this study: PubMed 38802569Yang PJ, Zhao XY, Kou YH, Liu J, Ren XY, Zhang YY, Wang ZD, Ge Z, Yuan WX, Qiu C, Tan B, Liu Q, Shi YN, Jiang YQ, Qiu C, Guo LH, Li JY, Huang XJ, Yu LY. Human amniotic epithelial stem cell is a cell therapy candidate for preventing acute graft-versus-host disease. Acta Pharmacol Sin. 2024 Nov;45(11):2339-2353. doi: 10.1038/s41401-024-01283-y. Epub 2024 May 27.
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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 principal investigator
Peking University People's Hospital
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hAECs in people with Acute-graft-versus-host Disease, run by Peking University People's Hospital at 2 sites 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 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: status not confirmed, as of the sponsor's last update on 1 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xiangyu Zhao (010-88325949, 13520122292@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of adverse events (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03764228, which also lists 1 linked publication.
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 1 Oct 2020.