LeukemiaNCT03759899
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation
An observational study of Leukemia, run by Peking University People's Hospital at 1 site in China.
Trial summary
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Leukemia
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2020to Jul 2022
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: leukemia patients with allogeneic HSCT
Who may be able to join
- leukemia patients with allogeneic HSCT
- KFS score >90
- after transplantation, the patient was implanted (peripheral blood neutrophil absolute value >500/ul for 3 consecutive days)
- no uncontrolled infection after transplantation
- activity II above aGVHD
- patients agreed to participate in the study
Who cannot join
- patients refused to participate in the study
- patients have poor compliance
- has received hormone therapy
- patients had serious heart, lung, liver, kidney and other vital organs damage
- researchers believe that patients who are not suitable for observation study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University Institute of Hematology
Beijing, Beijing Municipality, 100044
Xiangyu Zhao
About this study
Official title: Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation
Read the detailed description
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
- Conditions
- Leukemia
- Medical subject headings
- Leukemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Cell counts of T cells, NK cells, B cells and monocytes
proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2018
- Study start1 Jul 2020
- Primary completionJul 2021 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LeukemiaStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 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
- NCT03759899
- Sponsor's protocol ID
- 2018PHB007-01
- Status last verified
- Sep 2020
- First submitted
- 19 Nov 2018
- Last updated
- 1 Oct 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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
- Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT03759899
- Acronym / sponsor ID
- 2018PHB007-01
- Conditions
- Leukemia
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 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
- Jul 2021 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 30 Nov 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.
hAECs Are Preliminarily Applied in Allogeneic Hematopoietic Stem Cell Transplantation
Detailed description
Establishment of Clinical Applicable Human Amniotic Epithelial Cell Products and Its Preliminary Application in Allogeneic Hematopoietic Stem Cell Transplantation
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- leukemia patients with allogeneic HSCT
Key inclusion criteria (6 listed)
- leukemia patients with allogeneic HSCT
- KFS score >90
- after transplantation, the patient was implanted (peripheral blood neutrophil absolute value >500/ul for 3 consecutive days)
- no uncontrolled infection after transplantation
- activity II above aGVHD
Key exclusion criteria (5 listed)
- patients refused to participate in the study
- patients have poor compliance
- has received hormone therapy
- patients had serious heart, lung, liver, kidney and other vital organs damage
- researchers believe that patients who are not suitable for observation study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cell counts of T cells, NK cells, B cells and monocytes
Time frame: Day 7
proliferation and apoptosis of T cells, NK cells, B cells and monocytes in peripheral blood of patients
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.
- Individual participant dataSharing planned: Undecided
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Leukemia, run by Peking University People's 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 6 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 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?
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, zhao_xy@bjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cell counts of T cells, NK cells, B cells and monocytes (time frame: Day 7). 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 1 Oct 2020.