ARDSPhase 1NCT01902082
Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
A Phase 1 study testing Mesenchymal stem cells in people with ARDS, run by Shaoxing Second Hospital at 1 site in China.
Trial summary
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- ARDS
- What is being tested?
- Mesenchymal stem cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteChina
- Study dates
- Nov 2012to Jun 2014
- Phase
- Phase 1
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ARDS diagnosed using Berlin definition
- Eligible patients were at least 18 years of age had acute onset of ARDS.
- Bilateral opacities in chest radiography
- No cardiac failure
- PaO2/FiO2 ratio < 200
Who cannot join
- 72 hours after all inclusion criteria met
- Pre-existing severe diseases of any major organs
- Pregnancy
- Pulmonary hypertension
- Malignant diseases
- HIV infections.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shaoxing Second Hospital
Shaoxing, Zhejiang, 312000
Guoping Zheng, MD, 13385851678, zgp28037@163.com
Jianguo Xu, PhD, 575-88053995, jxu6325@yahoo.com
About this study
Official title: Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.
- Conditions
- ARDS
- Being tested
- Mesenchymal stem cells, Placebo
- Keywords
- ARDS, mesenchymal stem cells, Safety, Cytokines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal stem cellsDrug
PlaceboDrug
Also called Intravenous saline infusion will be designated as placebo.
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal stem cell arm | Experimental | Patients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment. Receives: Drug: Mesenchymal stem cells |
| Placebo | Placebo comparator | Patients received one dose of normal saline. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the adverse events between mesenchymal stem cell treatment and placebo groups
Measured: From day 0 at the start of treatment to day 28.
Secondary outcomes (1)
Hospital indices by treatment group
Days in hospital ICU free days at day 28 Ventilator free days at day 28
Measured: From admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2013 (estimated)
- Study startNov 2012
- Primary completionJun 2014 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ARDSStudies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shaoxing Second Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01902082
- Sponsor's protocol ID
- MSCs in ARDS
- Status last verified
- Jul 2013
- First submitted
- 14 Jul 2013
- Last updated
- 18 Jul 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Zheng G, Huang L, Tong H, Shu Q, Hu Y, Ge M, Deng K, Zhang L, Zou B, Cheng B, Xu J. Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study. Respir Res. 2014 Apr 4;15(1):39. doi: 10.1186/1465-9921-15-39.
PubMed 24708472
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Study of Allogeneic Adipose-derived Mesenchymal Stem Cells in Acute Respiratory Distress Syndrome
- ClinicalTrials.gov ID
- NCT01902082
- Acronym / sponsor ID
- MSCs in ARDS
- Conditions
- ARDS
- Keywords
- ARDS, mesenchymal stem cells, Safety, Cytokines
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Shaoxing Second HospitalUniversity, hospital or other
- Study start
- Nov 2012
- Primary completion
- Jun 2014 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 18 Jul 2013 (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.
Currently, there is no proven effective pharmacologic treatment available for patients with the acute respiratory distress syndrome (ARDS). Mesenchymal stem cells have been shown to be effective in treating several inflammatory diseases. The main purpose of this study is to assess the safety of allogeneic adipose-derived mesenchymal stem cells in patients with ARDS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal stem cell arm | Experimental | Drug: Mesenchymal stem cellsPatients received one dose of 1x 10^6 allogeneic adipose-derived mesenchymal stem cells/kg body weight intravenously within 48 hours of enrollment. |
| Placebo | Placebo comparator | Drug: PlaceboPatients received one dose of normal saline. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- ARDS diagnosed using Berlin definition
- Eligible patients were at least 18 years of age had acute onset of ARDS.
- Bilateral opacities in chest radiography
- No cardiac failure
- PaO2/FiO2 ratio < 200
Key exclusion criteria (6 listed)
- 72 hours after all inclusion criteria met
- Pre-existing severe diseases of any major organs
- Pregnancy
- Pulmonary hypertension
- Malignant diseases
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 |
|---|---|---|
| Mesenchymal stem cells | Drug | Mesenchymal stem cell arm |
| PlaceboAlso: Intravenous saline infusion will be designated as placebo. | Drug | Placebo |
Primary outcome
Compare the adverse events between mesenchymal stem cell treatment and placebo groups
Time frame: From day 0 at the start of treatment to day 28.
1 secondary outcome
Hospital indices by treatment group
Time frame: From admission to discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2013.
- Derived from this study: PubMed 24708472Zheng G, Huang L, Tong H, Shu Q, Hu Y, Ge M, Deng K, Zhang L, Zou B, Cheng B, Xu J. Treatment of acute respiratory distress syndrome with allogeneic adipose-derived mesenchymal stem cells: a randomized, placebo-controlled pilot study. Respir Res. 2014 Apr 4;15(1):39. doi: 10.1186/1465-9921-15-39.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Mesenchymal stem cells in people with ARDS, run by Shaoxing Second 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 5 inclusion and 6 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 18 Jul 2013. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this 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.
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 Guoping Zheng, MD (13385851678, zgp28037@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compare the adverse events between mesenchymal stem cell treatment and placebo groups (time frame: From day 0 at the start of treatment to day 28.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01902082, which also lists 1 linked publication.
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 18 Jul 2013.