Acute Lung InjuryPhase 1/2UCMSC-ALINCT02444455
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Acute Lung Injury
A Phase 1/2 study testing UCMSC group in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Affiliated Hospital to Academy of Military Medical Sciences at 1 site in China.
Trial summary
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study. Read more about this study
- Who is it for?
- Ages 35 to 70 years
- Conditions the study is for
- Acute Lung Injury, Acute Respiratory Distress Syndrome
- What is being tested?
- UCMSC group
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- May 2015to Dec 2017
- Phase
- Phase 1/2
- 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 35 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent
- Age between 35 and 70 y
- Acute onset within 7 days.
- Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg
- Bilateral infiltrates on chest radiography
- No cardiac failure
Who cannot join
- Declined to sign informed consent
- Socially and mentally disabilities
- Malignant diseases
- Combined with severe infectious diseases
- Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
- Pregnant or perinatal women
- Severe diseases of any major organs
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Respiration,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071
Changqing Bai, M.D., +86-010-66947356, baicq307@163.com
About this study
Official title: Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.
Read the detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.
Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.
Clinical results will be analyzed after completion of 14 days of followup.
- Being tested
- UCMSC group
- Keywords
- cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation, ALI, ARDS
- Medical subject headings
- Acute Lung Injury, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCMSC groupBiological
Human umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times.
| Study group | Role | What they receive |
|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by intravenous infusion Receives: Biological: UCMSC group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety will be determined by the assessment of major adverse events
Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.
Measured: From day 0 at the start of treatment to day 14.
Secondary outcomes (4)
Quantify pulmonary respiratory function measured by chest computerized tomography
Measured: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
The efficacy of UC-MSC treatment was measured by arterial blood gas analysis
Measured: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6
Measured: 6 hours post-infusion, and days 1, 2, and 3
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8
Measured: 6 hours post-infusion, and days 1, 2, and 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2015 (estimated)
- Study startMay 2015
- Primary completionMar 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Lung InjuryStudies 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
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Responsible party
- Sponsor
- Investigators
- Bing Liu, M.D., Study chair, 307-IVY Translational Medicine CenterChangqing Bai, M.D., Study director, Department of Respiration, Affiliated Hospital to Academy of Military Medical SciencesHuiying Liu, M.D., Principal investigator, Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444455
- Sponsor's protocol ID
- 307-IVY-SC-003
- Acronym
- UCMSC-ALI
- Status last verified
- May 2015
- First submitted
- 8 May 2015
- Last updated
- 14 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy of Human Umbilical-Cord-Derived Mesenchymal Stem Cell Transplantation in Acute Lung Injury
- ClinicalTrials.gov ID
- NCT02444455
- Acronym / sponsor ID
- UCMSC-ALI / 307-IVY-SC-003
- Keywords
- cellular therapy, acute lung injury, acute respiratory distress snydrome, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation, ALI, ARDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Affiliated Hospital to Academy of Military Medical SciencesUniversity, hospital or other
- Collaborators
- Ivy Institute of Stem Cells Co. Ltd
- Study start
- May 2015
- Primary completion
- Mar 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 14 May 2015 (estimated)
- 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.
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with Acute Lung Injury ,open label, controlled prospective study.
Detailed description
Phase I-II Clinical Trial - Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with acute lung injury,open label, controlled prospective study.
Every patient will maintain their standard treatment of acute lung injury, with maximum tolerated dosage without side effects.
The day of infusion will be considered day zero. From that moment, followup will be divided into 2,7,14 days.
Clinical results will be analyzed after completion of 14 days of followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCMSC group | Experimental | Biological: UCMSC groupHuman umbilical cord MSCs are administrated to patients by intravenous infusion |
Who may qualify
- Ages
- 35 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Signed informed consent
- Age between 35 and 70 y
- Acute onset within 7 days.
- Oxygenation index:200<PaO2/FiO2≤300mmHg; alveolar-arterial oxygen differences:P(A-a)O2>35mmHg
- Bilateral infiltrates on chest radiography
Key exclusion criteria (7 listed)
- Declined to sign informed consent
- Socially and mentally disabilities
- Malignant diseases
- Combined with severe infectious diseases
- Patients with positive blood tests for Hepatitis B or Hepatitis C or HIV or tuberculosis at the time of screening
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 |
|---|---|---|
| UCMSC groupHuman umbilical cord MSCs are transplanted by intravenous infusion(5×10^5/kg) once a day,a total of three times. | Biological | UCMSC group |
Primary outcome
Safety will be determined by the assessment of major adverse events
Time frame: From day 0 at the start of treatment to day 14.
Safety will be determined by the assessment of major adverse events defined as death, and the incidence of prespecified infusion-associated events and non-serious adverse events thought to be related to the MSC infusion.
4 secondary outcomes
Quantify pulmonary respiratory function measured by chest computerized tomography
Time frame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
The efficacy of UC-MSC treatment was measured by arterial blood gas analysis
Time frame: Participants will be followed for the duration of hospital,2 day post-infusion, and days 7,14.
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-6
Time frame: 6 hours post-infusion, and days 1, 2, and 3
The efficacy of UC-MSC treatment was measured by biological markers,including markers of inflammation，IL-8
Time frame: 6 hours post-infusion, and days 1, 2, and 3
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2015.
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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.
Bing Liu, M.D. study chair
307-IVY Translational Medicine Center
Changqing Bai, M.D. study director
Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
Huiying Liu, M.D. principal investigator
Department of Respiration, Affiliated Hospital to Academy of Military Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing UCMSC group in people with Acute Lung Injury and Acute Respiratory Distress Syndrome, run by Affiliated Hospital to Academy of Military Medical Sciences 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 7 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 14 May 2015. 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Changqing Bai, M.D. (+86-010-66947356, baicq307@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety will be determined by the assessment of major adverse events (time frame: From day 0 at the start of treatment to day 14.). 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 14 May 2015.