Paraquat PoisoningPhase 1/2UCMSC-PQLINCT02444858
Human Umbilical-Cord-Derived Mesenchymal Stem Cell Therapy in Paraquat Poisoning Induced Lung Injury
A Phase 1/2 study testing UCMSC group in people with Paraquat Poisoning and Lung Injury, 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 paraquat poisoning induced lung injury, randomized,single blind, controlled prospective study. Read more about this study
- Who is it for?
- Ages 15 to 60 years
- Conditions the study is for
- Paraquat Poisoning, Lung Injury
- 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
- 40 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 15 to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 15 and 60 y(including 15y)
- A history of ingestion paraquat, and hospitalization within 96 hours after paraquat poisoning
- No previous organic disease history of serious heart, liver, kidney and lung, etc;
- Patients with moderate poisoning (oral dose of 20-40mg of PQ ion/kg of body weight)
- Patient or his legal agent signed informed consent voluntarily
- Capable of good communication with researchers and follow the entire test requirements
Who cannot join
- Refused to sign informed consent
- Elderly high-risk patients
- Socially and mentally disabilities
- Hepatitis B, hepatitis C, HIV and tuberculosis patients
- Pregnant or perinatal women
- Severe organ failure patients
- Patients participated in clinical trials of other drugs within 3 months
- Other circumstances not suitable to the trial(mixed toxicants poisoning)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of poisoning and treatment,Affiliated Hospital to Academy of Military Medical Sciences
Beijing, 100071
Zewu Qiu, M.D., +86-010-66947376, qiuzw828@163.com
About this study
Official title: Safety and Efficacy of Human Umbilical-Cord-derived Mesenchymal Stem Cell Transplantation in Paraquat Poisoning Induced Lung Injury
Phase I-II Clinical Trial-Safety and efficacy of umbilical-cord-derived mesenchymal stem cell (UC-MSC) in patients with paraquat poisoning induced lung injury, randomized,single blind, 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 paraquat poisoning induced lung injury,randomized, single blind, controlled prospective study.
Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.
Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.
The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.
Clinical results will be analyzed after completion of 2 months of followup.
- Conditions
- Paraquat Poisoning, Lung Injury
- Being tested
- UCMSC group, Control group(Normal saline)
- Keywords
- paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation
- Medical subject headings
- Lung Injury
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 injection(5×10^5/kg) ，once a day,a total of three times.
Control group(Normal saline)Other
Normal saline in same volume as MSCs are transplanted to patients.
| Study group | Role | What they receive |
|---|---|---|
| UCMSC group | Experimental | Human umbilical cord MSCs are administrated to patients by intravenous injection Receives: Biological: UCMSC group |
| Control group(Normal saline) | Other | Patients will receive normal saline at the same time points as that in experimental group. Receives: Other: Control group(Normal saline) |
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 trial-related death,required hospitalization or prolonged hospitalization time, persistent or significant loss of organ function，other serious adverse events.
Measured: 2 months
Secondary outcomes (4)
The efficacy of UC-MSC treatment was measured clinical evaluation.
The efficacy of UC-MSC treatment was measured clinical evaluation defined as wheezing, coughing and other symptoms improved than before.
Measured: 2 months
The efficacy of UC-MSC treatment was measured by chest computerized tomography.
The efficacy of UC-MSC treatment was quantified by the differences between the two groups and from baseline to 2 months, as measured by chest computerized tomography(CT).
Measured: 2 months
The efficacy of UC-MSC treatment was monitored by pulmonary function.
The pulmonary function efficacy of UC-MSC treatment was measured by arterial blood gas analysis (oxygenation index).
Measured: 2 months
The efficacy of UC-MSC treatment was measured by lab Indicators.
The efficacy of UC-MSC treatment was measured by lab Indicators defined as blood cell analysis, markers of inflammation (C-reactive protein).
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2015 (estimated)
- Study startMay 2015
- Primary completionMay 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 Paraquat PoisoningStudies 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 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 CenterZewu Qiu, M.D., Study director, Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical SciencesHaochun Wang, M.D., Principal investigator, Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical SciencesXiaobo Peng, M.D., Principal investigator, Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical SciencesChunyan Wang, M.D., Principal investigator, Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02444858
- Sponsor's protocol ID
- 307-IVY-SC-004
- Acronym
- UCMSC-PQLI
- Status last verified
- Apr 2015
- First submitted
- 12 May 2015
- Last updated
- 15 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 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 Paraquat Poisoning Induced Lung Injury
- ClinicalTrials.gov ID
- NCT02444858
- Acronym / sponsor ID
- UCMSC-PQLI / 307-IVY-SC-004
- Conditions
- Paraquat Poisoning, Lung Injury
- Keywords
- paraquat poisoning, lung injury, stem cell therapy, human umbilical cord mesenchymal stem cell, phase 1/2 clinical study, allogeneic stem cell transplantation
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 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
- May 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 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 paraquat poisoning induced lung injury, randomized,single blind, 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 paraquat poisoning induced lung injury,randomized, single blind, controlled prospective study.
Forty patients will be selected and randomized into two groups: the first group of 20 patients will receive three-time injection of UC-MSC and the remaining 20 patients will comprise the control group.
Every patient will maintain their standard treatment of paraquat poisoning, with maximum tolerated dosage without side effects.
The day of last infusion will be considered day zero. From that moment, followup will be divided into 2 d,7 d,14 d, 28 d and 2 m.
Clinical results will be analyzed after completion of 2 months of followup.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UCMSC group | Experimental | Biological: UCMSC groupHuman umbilical cord MSCs are administrated to patients by intravenous injection |
| Control group(Normal saline) | Other | Other: Control group(Normal saline)Patients will receive normal saline at the same time points as that in experimental group. |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- Age between 15 and 60 y(including 15y)
- A history of ingestion paraquat, and hospitalization within 96 hours after paraquat poisoning
- No previous organic disease history of serious heart, liver, kidney and lung, etc;
- Patients with moderate poisoning (oral dose of 20-40mg of PQ ion/kg of body weight)
- Patient or his legal agent signed informed consent voluntarily
Key exclusion criteria (8 listed)
- Refused to sign informed consent
- Elderly high-risk patients
- Socially and mentally disabilities
- Hepatitis B, hepatitis C, HIV and tuberculosis patients
- Pregnant or perinatal women
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 injection(5×10^5/kg) ，once a day,a total of three times. | Biological | UCMSC group |
| Control group(Normal saline)Normal saline in same volume as MSCs are transplanted to patients. | Other | Control group(Normal saline) |
Primary outcome
Safety will be determined by the assessment of major adverse events.
Time frame: 2 months
Safety will be determined by the assessment of major adverse events defined as trial-related death,required hospitalization or prolonged hospitalization time, persistent or significant loss of organ function，other serious adverse events.
4 secondary outcomes
The efficacy of UC-MSC treatment was measured clinical evaluation.
Time frame: 2 months
The efficacy of UC-MSC treatment was measured by chest computerized tomography.
Time frame: 2 months
The efficacy of UC-MSC treatment was monitored by pulmonary function.
Time frame: 2 months
The efficacy of UC-MSC treatment was measured by lab Indicators.
Time frame: 2 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2015.
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
Zewu Qiu, M.D. study director
Department of poisoning treatment,Affiliated Hospital to Academy of Military Medical Sciences
Haochun Wang, M.D. principal investigator
Department of poisoning treatment,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 Paraquat Poisoning and Lung Injury, 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 8 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 15 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 Zewu Qiu, M.D. (+86-010-66947376, qiuzw828@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: 2 months). 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 May 2015.