Respiratory Distress Syndrome, AdultPhase 2STARTNCT02097641
Human Mesenchymal Stromal Cells For Acute Respiratory Distress Syndrome (START)
A Phase 2 study testing Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells and Plasma-Lyte A in people with Respiratory Distress Syndrome, Adult, run by Michael A. Matthay at 6 sites in United States.
Trial summary
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Respiratory Distress Syndrome, Adult
- What is being tested?
- Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells and Plasma-Lyte A
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 6 sitesUnited States
- Study dates
- 15 Mar 2014to 9 Feb 2018
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:
- Acute onset (defined below) of:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
- No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
Who cannot join
- Age less than 18 years
- Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Pregnant or breast-feeding
- Prisoner
- Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
- Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%
Show all 18Show fewer
- Moderate to severe liver failure (Childs-Pugh Score > 12)
- Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen
- Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest)
- Major trauma in the prior 5 days
- Lung transplant patient
- No consent/inability to obtain consent
- Moribund patient not expected to survive 24 hours
- World Health Organization (WHO) Class III or IV pulmonary hypertension
- Documented deep venous thrombosis or pulmonary embolism within past 3 months
- No arterial line/no intent to place an arterial line
- No intent/unwillingness to follow lung protective ventilation strategy or fluid management protocol
- Currently receiving extracorporeal life support (ECLS) or high-frequency oscillatory ventilation (HFOV)
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Massachusetts General Hospital
Boston, Massachusetts, 02114
Ohio State University
Columbus, Ohio, 43210
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
University of Minnesota Medical Center
Saint Paul, Minnesota, 55108
University of California San Francisco
San Francisco, California, 94143
Stanford University
Stanford, California, 94305
About this study
Official title: Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).
Read the detailed description
We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.
- Conditions
- Respiratory Distress Syndrome, Adult
- Being tested
- Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells, Plasma-Lyte A
- Keywords
- Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells, Acute Respiratory Distress Syndrome
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal CellsBiological
Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes.
Plasma-Lyte ABiological
Plasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Human Mesenchymal Stromal Cells (hMSCs) | Experimental | A single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes. Receives: Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells |
| Plasma-Lyte A (placebo) | Placebo comparator | A single dose of Plasma-Lyte A was administered intravenously over approximately 60-80 minutes. Receives: Biological: Plasma-Lyte A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion
Within 6 h of study product infusion:
- Increase in vasopressor dose to the following values or higher:
- Norepinephrine 10 μg/min
- Phenylephrine 100 μg/min
- Dopamine 10 μg/kg per min
- Epinephrine 0.1 μg/kg per min or addition of a third vasopressor
- New ventricular tachycardia, ventricular fibrillation or asystole
- New cardiac arrhythmia requiring cardioversion
- Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95%
- Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)
Measured: 6 hours
Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion
Within 24 h of study product infusion
- Any cardiac arrest or death
Measured: 24 hours
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
Safety endpoint: Any unexpected severe adverse events in two groups
Measured: 12 months
Secondary outcomes (16)
PaO2:FiO2 Change From Baseline to Day 3
Efficacy endpoint: PaO2:FiO2 change from baseline to day 3
Measured: baseline and day 3
Lung Injury Score From Baseline to Day 3
Murray score for acute lung injury. The range is 0 to 4. The higher score, the worst outcome.
Measured: baseline and day 3
Oxygenation Index Change From Baseline to Day 2
Oxygenation index with the following validated measure of respiratory function: FiO2 (%) x mean airway pressure / PaO2
Measured: baseline and day 2
SOFA Score Change From Baseline to Day 3
Sequential organ failure assessment score (SOFA). The SOFA score ranges from 0 to 24. The higher, the worse.
Measured: baseline and day 3
Number of Patients Death to Day 28
Efficacy endpoint: all-cause mortality at day 28
Measured: 28 days
Mortality to Day 60
Efficacy endpoint: all-cause mortality at day 60
Measured: 60 days
Number of Ventilator-free Days to Day 28
Efficacy endpoint: Number of ventilator-free days to day 28.
Measured: 28 days
Non-pulmonary Organ-failure-free Days to Day 28
Efficacy endpoint: Non-pulmonary organ-failure-free days to day 28
Measured: 28 days
Angiopoietin 2 Change From Baseline to 6 h
Biological markers of endothelial injury: angiopoietin 2
Measured: baseline and 6 hours
Angiopoietin 2 Change From Baseline to 24 h
Biological markers of endothelial injury: angiopoietin 2
Measured: baseline and 24 hours
Interleukin 6 Change From Baseline to 6 h
Biological markers of inflammation: interleukin 6
Measured: baseline and 6 hours
Interleukin 6 Change From Baseline to 24 h
Biological markers of inflammation: interleukin 6
Measured: baseline and 24 hours
Interleukin 8 Change From Baseline to 6 h
Biological markers of inflammation: interleukin 8
Measured: baseline and 6 hours
Interleukin 8 Change From Baseline to 24 h
Biological markers of inflammation: interleukin 8
Measured: baseline and 24 hours
RAGE Change From Baseline to 6 h
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Measured: baseline and 6 hours
RAGE Change From Baseline to 24 h
Biological markers of alveolar epithelial injury: receptor for advanced glycation end products (RAGE)
Measured: baseline and 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study start15 Mar 2014
- Primary completion9 Mar 2017
- Study completion9 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Respiratory Distress Syndrome, AdultStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michael A. Matthay
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Stanford University, University of Pittsburgh, University of Minnesota, Ohio State University
- Responsible party
- Sponsor-investigator, Michael A. Matthay, University of California, San Francisco
- Investigators
- Michael A Matthay, MD, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02097641
- Sponsor's protocol ID
- UCSF-hMSC-ARDS-P2
- Other IDs
- 1U01HL108713-01
- Acronym
- START
- Status last verified
- Mar 2019
- First submitted
- 19 Mar 2014
- Last updated
- 10 Apr 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Publications
Matthay MA, Calfee CS, Zhuo H, Thompson BT, Wilson JG, Levitt JE, Rogers AJ, Gotts JE, Wiener-Kronish JP, Bajwa EK, Donahoe MP, McVerry BJ, Ortiz LA, Exline M, Christman JW, Abbott J, Delucchi KL, Caballero L, McMillan M, McKenna DH, Liu KD. Treatment with allogeneic mesenchymal stromal cells for moderate to severe acute respiratory distress syndrome (START study): a randomised phase 2a safety trial. Lancet Respir Med. 2019 Feb;7(2):154-162. doi: 10.1016/S2213-2600(18)30418-1. Epub 2018 Nov 16.
PubMed 30455077Wick KD, Leligdowicz A, Zhuo H, Ware LB, Matthay MA. Mesenchymal stromal cells reduce evidence of lung injury in patients with ARDS. JCI Insight. 2021 Jun 22;6(12):e148983. doi: 10.1172/jci.insight.148983.
PubMed 33974564Liu KD, Wilson JG, Zhuo H, Caballero L, McMillan ML, Fang X, Cosgrove K, Calfee CS, Lee JW, Kangelaris KN, Gotts JE, Rogers AJ, Levitt JE, Wiener-Kronish JP, Delucchi KL, Leavitt AD, McKenna DH, Thompson BT, Matthay MA. Design and implementation of the START (STem cells for ARDS Treatment) trial, a phase 1/2 trial of human mesenchymal stem/stromal cells for the treatment of moderate-severe acute respiratory distress syndrome. Ann Intensive Care. 2014 Jul 3;4:22. doi: 10.1186/s13613-014-0022-z. eCollection 2014.
PubMed 25593740Asmussen S, Ito H, Traber DL, Lee JW, Cox RA, Hawkins HK, McAuley DF, McKenna DH, Traber LD, Zhuo H, Wilson J, Herndon DN, Prough DS, Liu KD, Matthay MA, Enkhbaatar P. Human mesenchymal stem cells reduce the severity of acute lung injury in a sheep model of bacterial pneumonia. Thorax. 2014 Sep;69(9):819-25. doi: 10.1136/thoraxjnl-2013-204980. Epub 2014 Jun 2.
PubMed 24891325
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Randomized, Multi-center Phase 2 Clinical Trial of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) for the Treatment of Acute Respiratory Distress Syndrome (ARDS)
- ClinicalTrials.gov ID
- NCT02097641
- Acronym / sponsor ID
- START / UCSF-hMSC-ARDS-P2
- Conditions
- Respiratory Distress Syndrome, Adult
- Keywords
- Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells, Acute Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Michael A. MatthayUniversity, hospital or other
- Collaborators
- National Heart, Lung, and Blood Institute (NHLBI), Massachusetts General Hospital, Stanford University, University of Pittsburgh, University of Minnesota, Ohio State University
- Study start
- 15 Mar 2014 (actual)
- Primary completion
- 9 Mar 2017 (actual)
- Study completion
- 9 Feb 2018 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Posted 10 Apr 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This was a Phase 2a, randomized, double-blind, placebo-controlled, multi-center trial to assess the safety and efficacy of a single dose of Allogeneic Bone Marrow-derived Human Mesenchymal Stromal Cells (hMSCs) infusion in patients with Acute Respiratory Distress Syndrome (ARDS).
Detailed description
We carried out a randomized, double-blind placebo-controlled trial of allogeneic bone marrow derived human mesenchymal stromal cells for treatment of moderate to severe ARDS in 60 patients, 40 MSC and 20 placebo, in a 2:1 randomization. This trial is the extension of the Phase 1 pilot trial (NCT01775774). Patients were followed daily for adverse events through day 28, death or hospital discharge, whichever occurs first. Vital status was collected at 6 and 12 months after study enrollment.
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 |
|---|---|---|
| Human Mesenchymal Stromal Cells (hMSCs) | Experimental | Biological: Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal CellsA single dose of 10 million cells/kg PBW (predicted body weight) Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes. |
| Plasma-Lyte A (placebo) | Placebo comparator | Biological: Plasma-Lyte AA single dose of Plasma-Lyte A was administered intravenously over approximately 60-80 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:
- A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)
- Bilateral infiltrates consistent with pulmonary edema on frontal chest radiograph
- No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.
Key exclusion criteria (18 listed)
- Age less than 18 years
- Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS
- Pregnant or breast-feeding
- Prisoner
- Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years
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 |
|---|---|---|
| Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal CellsAllogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells was administered intravenously over approximately 60-80 minutes. | Biological | Human Mesenchymal Stromal Cells (hMSCs) |
| Plasma-Lyte APlasma-Lyte A placebo was administered intravenously over approximately 60-80 minutes. | Biological | Plasma-Lyte A (placebo) |
Primary outcome
Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion
Time frame: 6 hours
Within 6 h of study product infusion: * Increase in vasopressor dose to the following values or higher: * Norepinephrine 10 μg/min * Phenylephrine 100 μg/min * Dopamine 10 μg/kg per min * Epinephrine 0.1 μg/kg per min or addition of a third vasopressor * New ventricular tachycardia, ventricular fibrillation or asystole * New cardiac arrhythmia requiring cardioversion * Hypoxaemia requiring an increase in FiO2 of 0·2 or more and an increase in PEEP of 5·0 or more to maintain SpO2 in the target range of 88-95% * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection (eg, urticaria, new bronchospasm)
Numbers of Patients Occurred Any Cardiac Arrest or Death Within 24 Hours of Study Infusion
Time frame: 24 hours
Within 24 h of study product infusion • Any cardiac arrest or death
Numbers of Patients Occurred Any Unexpected Severe Adverse Events (Including All-cause Deaths)
Time frame: 12 months
Safety endpoint: Any unexpected severe adverse events in two groups
16 secondary outcomes
PaO2:FiO2 Change From Baseline to Day 3
Time frame: baseline and day 3
Lung Injury Score From Baseline to Day 3
Time frame: baseline and day 3
Oxygenation Index Change From Baseline to Day 2
Time frame: baseline and day 2
SOFA Score Change From Baseline to Day 3
Time frame: baseline and day 3
Number of Patients Death to Day 28
Time frame: 28 days
Mortality to Day 60
Time frame: 60 days
Number of Ventilator-free Days to Day 28
Time frame: 28 days
Non-pulmonary Organ-failure-free Days to Day 28
Time frame: 28 days
Angiopoietin 2 Change From Baseline to 6 h
Time frame: baseline and 6 hours
Angiopoietin 2 Change From Baseline to 24 h
Time frame: baseline and 24 hours
Interleukin 6 Change From Baseline to 6 h
Time frame: baseline and 6 hours
Interleukin 6 Change From Baseline to 24 h
Time frame: baseline and 24 hours
Interleukin 8 Change From Baseline to 6 h
Time frame: baseline and 6 hours
Interleukin 8 Change From Baseline to 24 h
Time frame: baseline and 24 hours
RAGE Change From Baseline to 6 h
Time frame: baseline and 6 hours
RAGE Change From Baseline to 24 h
Time frame: baseline and 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 30455077Matthay MA, Calfee CS, Zhuo H, Thompson BT, Wilson JG, Levitt JE, Rogers AJ, Gotts JE, Wiener-Kronish JP, Bajwa EK, Donahoe MP, McVerry BJ, Ortiz LA, Exline M, Christman JW, Abbott J, Delucchi KL, Caballero L, McMillan M, McKenna DH, Liu KD. Treatment with allogeneic mesenchymal stromal cells for moderate to severe acute respiratory distress syndrome (START study): a randomised phase 2a safety trial. Lancet Respir Med. 2019 Feb;7(2):154-162. doi: 10.1016/S2213-2600(18)30418-1. Epub 2018 Nov 16.
- Derived from this study: PubMed 33974564Wick KD, Leligdowicz A, Zhuo H, Ware LB, Matthay MA. Mesenchymal stromal cells reduce evidence of lung injury in patients with ARDS. JCI Insight. 2021 Jun 22;6(12):e148983. doi: 10.1172/jci.insight.148983.
- Derived from this study: PubMed 25593740Liu KD, Wilson JG, Zhuo H, Caballero L, McMillan ML, Fang X, Cosgrove K, Calfee CS, Lee JW, Kangelaris KN, Gotts JE, Rogers AJ, Levitt JE, Wiener-Kronish JP, Delucchi KL, Leavitt AD, McKenna DH, Thompson BT, Matthay MA. Design and implementation of the START (STem cells for ARDS Treatment) trial, a phase 1/2 trial of human mesenchymal stem/stromal cells for the treatment of moderate-severe acute respiratory distress syndrome. Ann Intensive Care. 2014 Jul 3;4:22. doi: 10.1186/s13613-014-0022-z. eCollection 2014.
- Derived from this study: PubMed 24891325Asmussen S, Ito H, Traber DL, Lee JW, Cox RA, Hawkins HK, McAuley DF, McKenna DH, Traber LD, Zhuo H, Wilson J, Herndon DN, Prough DS, Liu KD, Matthay MA, Enkhbaatar P. Human mesenchymal stem cells reduce the severity of acute lung injury in a sheep model of bacterial pneumonia. Thorax. 2014 Sep;69(9):819-25. doi: 10.1136/thoraxjnl-2013-204980. Epub 2014 Jun 2.
- Individual participant dataSharing planned: No
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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.
Michael A Matthay, MD principal investigator
University of California, San Francisco
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Allogeneic Bone Marrow-Derived Human Mesenchymal Stromal Cells and Plasma-Lyte A in people with Respiratory Distress Syndrome, Adult, run by Michael A. Matthay at 6 sites in United States.
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 18 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 10 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in United States. 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 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?
Yes. Results are posted in the registry (first posted 10 Apr 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Numbers of Patients Occurred Pre-specified Infusion Associated Events Occurring Within 6 Hours of Study Infusion (time frame: 6 hours). 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?
On the ClinicalTrials.gov record for NCT02097641, which also lists 4 linked publications.
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 10 Apr 2019.