SepsisNCT04850469
Study of MSC-Exo on the Therapy for Intensively Ill Children
An observational study of Sepsis and Critical Illness, run by Children's Hospital of Fudan University at 1 site in China.
Trial summary
At present, a number of projects related to MSCs have been approved for graft-versus-host disease, myocardial infarction, Crohn's disease and other diseases, indicating a strong therapeutic potential of MSCs. However, the efficacy of MSC-Exo for severely infected children is not fully evaluated. Read more about this study
- Who is it for?
- Ages 29 days to 18 years
- Conditions the study is for
- Sepsis, Critical Illness
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2022to 31 Dec 2024
- 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 29 days to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Who may be able to join
- children hospitalized in PICU of Children's Hospital of Fudan University
Who cannot join
- discharge within 48 hours
- patients without informed consent
- incomplete clinical and demographic data
Trial locations and contacts
1 site in 1 country.
China1 site
Children's Hospital of Fudan University
Shanghai, Shanghai Municipality
About this study
Official title: Study of Exosomes Derived From Mesenchymal Stem Cells on the Therapy for Children With Severe Infection
At present, a number of projects related to MSCs have been approved for graft-versus-host disease, myocardial infarction, Crohn's disease and other diseases, indicating a strong therapeutic potential of MSCs. However, the efficacy of MSC-Exo for severely infected children is not fully evaluated. In our study, patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. This study will evaluate the application and therapeutic effect of MSC-Exo in severely infected children, and determine the Optimal dosage and infusion.
Read the detailed description
Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multidirectional differentiation potential. studies revealed that local or systemic administration of mesenchymal stem cell-derivrd exosomes (MSC-Exo) efficiently suppressed detrimental immune response in inflamed tissues and promoted survival and regeneration of injured parenchymal cells. European Union countries have written MSCs into treatment guidelines for refractory graft-versus-host disease.
In China, the technology for isolation, in vitro culture and expansion of MSCs is already mature. With further research on the therapeutic efficacy of MSC-Exo and the development of clinical trials, it is expected to become a treatment for severe illness.
A predictable infection plan is going to be widely used in clinics to provide individualized treatment for patients, improve the prognosis of patients and improve the quality of life.
The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded.
- Conditions
- Sepsis, Critical Illness
- Keywords
- Sepsis, Critical Illness, Mesenchymal Stem Cell Derived Exosomes
- Medical subject headings
- Sepsis, Critical Illness
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 |
|---|---|---|
| trial group | Mesenchymal Stem Cell-Derived Exosomes | |
| control group | conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The death rate of children
The death rate of children in 28 days after their discharged from PICU
Measured: within 28 days after they discharged from PICU
Marshall Multiple Organ Dysfunction Score
The Marshall Multiple Organ Dysfunction Score (MODS) assesses the same six organ systems using slightly different values for four grades of organ dysfunction. The total score, ranging from 0 to 24, arises from the sum of all single organ scores using the first measured value of the day. Intervals for the most abnormal value of each variable were constructed on a scale from 0 to 4 so that a value of 0 represented essentially normal function and was associated with an ICU mortality rate of < 5%, whereas a value of 4 represented marked functional derangement and an ICU mortality rate of > or = 50%.
Measured: Within 3 to 15 days after the start of treatment
the APPS score
The APPS is a 9-point score that is calculated by measuring the age, PaO2/FIO2 ratio, and plateau pressure at 24 h after the patient is diagnosed with moderate to severe ARDS and counting each one to 1-3. Since many variables are not needed for calculations, clinicians can easily predict the in-hospital mortality of mechanically ventilated patients with moderate to severe ARDS patients at bedside.
Measured: Within 3 to 15 days after the start of treatment
Secondary outcomes (1)
length of stay in PICU
Time from PICU admission to discharge
Measured: up to 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2021
- Study start1 Sep 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Dec 2024 (estimated)
Why it stopped: Lacking of funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Children's Hospital of Fudan 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Hospital of Fudan University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Guoping Lu, Doctor, Principal investigator, Children's Hospital of Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04850469
- Sponsor's protocol ID
- fdpicu-13
- Status last verified
- Jun 2022
- First submitted
- 26 Mar 2021
- Last updated
- 15 Jun 2022
- 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 15 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Exosomes Derived From Mesenchymal Stem Cells on the Therapy for Children With Severe Infection
- ClinicalTrials.gov ID
- NCT04850469
- Acronym / sponsor ID
- fdpicu-13
- Conditions
- Sepsis, Critical Illness
- Keywords
- Sepsis, Critical Illness, Mesenchymal Stem Cell Derived Exosomes
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Lacking of funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Children's Hospital of Fudan UniversityUniversity, hospital or other
- Study start
- 1 Sep 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 20 Apr 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.
At present, a number of projects related to MSCs have been approved for graft-versus-host disease, myocardial infarction, Crohn's disease and other diseases, indicating a strong therapeutic potential of MSCs. However, the efficacy of MSC-Exo for severely infected children is not fully evaluated. In our study, patients who met the inclusion criteria will be divided into trial group and control group. Clinical and demographic data, as well as treatment outcome will be collected from the electronic health record. This study will evaluate the application and therapeutic effect of MSC-Exo in severely infected children, and determine the Optimal dosage and infusion.
Detailed description
Mesenchymal stem cells (MSCs) are pluripotent stem cells with high self-renewal ability and multidirectional differentiation potential. studies revealed that local or systemic administration of mesenchymal stem cell-derivrd exosomes (MSC-Exo) efficiently suppressed detrimental immune response in inflamed tissues and promoted survival and regeneration of injured parenchymal cells. European Union countries have written MSCs into treatment guidelines for refractory graft-versus-host disease.
In China, the technology for isolation, in vitro culture and expansion of MSCs is already mature. With further research on the therapeutic efficacy of MSC-Exo and the development of clinical trials, it is expected to become a treatment for severe illness.
A predictable infection plan is going to be widely used in clinics to provide individualized treatment for patients, improve the prognosis of patients and improve the quality of life.
The investigators intend to enroll all children who were hospitalized in pediatric intensive care unit PICU of Children's Hospital of Fudan University from January 2022 to December 2023. Children with a PICU length of day less than 48h will be excluded.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| trial group | – | –Mesenchymal Stem Cell-Derived Exosomes |
| control group | – | –conventional treatment |
Who may qualify
- Ages
- 29 days to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- All children hospitalized in PICU of Children's Hospital of Fudan University from January 2022 to December 2023
Key inclusion criteria (1 listed)
- children hospitalized in PICU of Children's Hospital of Fudan University
Key exclusion criteria (3 listed)
- discharge within 48 hours
- patients without informed consent
- incomplete clinical and demographic data
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
The death rate of children
Time frame: within 28 days after they discharged from PICU
The death rate of children in 28 days after their discharged from PICU
Marshall Multiple Organ Dysfunction Score
Time frame: Within 3 to 15 days after the start of treatment
The Marshall Multiple Organ Dysfunction Score (MODS) assesses the same six organ systems using slightly different values for four grades of organ dysfunction. The total score, ranging from 0 to 24, arises from the sum of all single organ scores using the first measured value of the day. Intervals for the most abnormal value of each variable were constructed on a scale from 0 to 4 so that a value of 0 represented essentially normal function and was associated with an ICU mortality rate of < 5%, whereas a value of 4 represented marked functional derangement and an ICU mortality rate of > or = 50%.
the APPS score
Time frame: Within 3 to 15 days after the start of treatment
The APPS is a 9-point score that is calculated by measuring the age, PaO2/FIO2 ratio, and plateau pressure at 24 h after the patient is diagnosed with moderate to severe ARDS and counting each one to 1-3. Since many variables are not needed for calculations, clinicians can easily predict the in-hospital mortality of mechanically ventilated patients with moderate to severe ARDS patients at bedside.
1 secondary outcome
length of stay in PICU
Time frame: up to 28 days
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 15 Jun 2022.
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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.
Guoping Lu, Doctor principal investigator
Children's Hospital of Fudan University
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 Sepsis and Critical Illness, run by Children's Hospital of Fudan University 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 1 inclusion and 3 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 15 Jun 2022. 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 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?
The death rate of children (time frame: within 28 days after they discharged from PICU). The study lists 3 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 15 Jun 2022.