PneumoniaMSCTPHSCTNCT05131412
Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation
An observational study of Pneumonia and Hematopoietic Stem Cell Transplantation, run by Guangzhou Women and Children's Medical Center at 1 site in China.
Trial summary
The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT). Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Pneumonia, Hematopoietic Stem Cell Transplantation
- How many people
- 107 participants
- Where
- 1 siteChina
- Study dates
- 8 Aug 2018to 31 Oct 2021
- 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 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Patients who underwent hematopoietic stem cell transplantation (HSCT) in Guangzhou Women and Children's Medical Center and got pneumonia after HSCT.
Who may be able to join
- patients with pneumonia after HSCT;
- patients under the age of 18 years;
- patients with normal pulmonary function before HSCT.
Who cannot join
- patients with other severe complications in progress when pneumonia occurred.
Trial locations and contacts
1 site in 1 country.
China1 site
Guangzhou Women and Children's Medical Center
Guangzhou, Guangdong, 510623
About this study
Official title: Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation: a a Retrospective Cohort Study
The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).
Read the detailed description
Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians.
Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated.
By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.
- Conditions
- Pneumonia, Hematopoietic Stem Cell Transplantation
- Keywords
- Mesenchymal Stromal Cell, Pneumonia, Hematopoietic Stem Cell Transplantation
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| mesenchymal stromal cell | Patients treated with mesenchymal stromal cell | |
| non-mesenchymal stromal cell | Patients treated without mesenchymal stromal cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
overall cure rate
the proportion of cured cases in all cases
Measured: 12 months
time to cure
the time from the first diagnosis of pneumonia to a cure was achieved
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2021
- Study start8 Aug 2018
- Primary completion1 Jan 2021
- Study completion31 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 107 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangzhou Women and Children's Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xu Yang, Guangzhou Women and Children's Medical Center
- Investigators
- Hua Jiang, Study director, Guangzhou Women and Children's Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05131412
- Sponsor's protocol ID
- GWCMC_HJ_XY_001
- Acronym
- MSCTPHSCT
- Status last verified
- Nov 2021
- First submitted
- 11 Nov 2021
- Last updated
- 3 Dec 2021
- 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 3 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stem Cells for the Treatment of Pneumonia Post Haematopoietic Stem Cell Transplantation: a a Retrospective Cohort Study
- ClinicalTrials.gov ID
- NCT05131412
- Acronym / sponsor ID
- MSCTPHSCT / GWCMC_HJ_XY_001
- Conditions
- Pneumonia, Hematopoietic Stem Cell Transplantation
- Keywords
- Mesenchymal Stromal Cell, Pneumonia, Hematopoietic Stem Cell Transplantation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 107 participants (actual)
- Lead sponsor
- Guangzhou Women and Children's Medical CenterUniversity, hospital or other
- Study start
- 8 Aug 2018 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 31 Oct 2021 (actual)
- First posted
- 23 Nov 2021 (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.
The aim of this study is to determine whether mesenchymal stromal cell (MSC) treatment contribute to the good prognosis in patients with transplant-related complication, pneumonia post hematopoietic stem cell transplantation (HSCT).
Detailed description
Hematopoietic stem cell transplantation (HSCT) is a standard therapy strategy for most hematologic disorders and malignancies. Despite the improved survival attributed to advances in HSCT including transplantation techniques and supportive care, transplant-related pneumonia (severe pneumonia in particular) remains the leading cause of death for most HSCT patients and a major challenge for clinicians.
Mesenchymal stromal cells (MSCs), a form of multipotent cells, have been applied in therapy for various intractable disorders. MSC exerts its therapeutic effect through various biological functions including immunoregulation, tissue repairing, self-renew and differentiating into various cell lines. The American Thoracic Society has also suggested MSCs as a cell therapy agent for lung diseases. However, MSC therapy for pneumonia following HSCT has not been well investigated.
By investigating the efficacy of MSC treatment for HSCT-related pneumonia via comparing the outcomes in patients with and without MSC treatment, this study will provide a promising therapy for HSCT-related pneumonia.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mesenchymal stromal cell | – | –Patients treated with mesenchymal stromal cell |
| non-mesenchymal stromal cell | – | –Patients treated without mesenchymal stromal cell |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Patients who underwent hematopoietic stem cell transplantation (HSCT) in Guangzhou Women and Children's Medical Center and got pneumonia after HSCT.
Key inclusion criteria (3 listed)
- patients with pneumonia after HSCT;
- patients under the age of 18 years;
- patients with normal pulmonary function before HSCT.
Key exclusion criteria (1 listed)
- patients with other severe complications in progress when pneumonia occurred.
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
overall cure rate
Time frame: 12 months
the proportion of cured cases in all cases
time to cure
Time frame: 12 months
the time from the first diagnosis of pneumonia to a cure was achieved
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2021.
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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.
Hua Jiang study director
Guangzhou Women and Children's Medical Center
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 Pneumonia and Hematopoietic Stem Cell Transplantation, run by Guangzhou Women and Children's Medical Center 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 3 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
overall cure rate (time frame: 12 months). 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 3 Dec 2021.