Idiopathic Pulmonary Fibrosis (IPF)Phase 1AETHERNCT02013700
Allogeneic Human Cells (hMSC)in Patients With Idiopathic Pulmonary Fibrosis Via Intravenous Delivery (AETHER)
A Phase 1 study testing Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Joshua M Hare at 1 site in United States.
Trial summary
This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Idiopathic Pulmonary Fibrosis (IPF)
- What is being tested?
- Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 9 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2013to 24 Nov 2016
- 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 40 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Provide written informed consent.
- Subjects age equal to or greater than 40 and equal to or less than 90 years at the time of signing the Informed Consent Form.
- Have a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) prior to screening
- Forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity (DLCO) ≥30% (corrected for hemoglobin but not alveolar volume).
- RVSP equal to or less than 50 mmHg, as documented by Doppler echo or right heart catheterization.
- Female subjects must be surgically sterile or post-menopausal (greater than 1 year).
Who cannot join
- HRCT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF.
- Infiltrative lung disease of any type other than Idiopathic Pulmonary Fibrosis (IPF), lungs disease related to fibrogenic agents, toxins, drugs or other exposures, granulomatous lung disease, pulmonary vascular disease, or known connective tissue disease.
- Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests or high resolution CT (HRCT), undergo blood draws, read and respond to questionnaires.
- Currently receiving (or received within four weeks of screening) any medication, treatment, or experimental agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF), except for patients receiving non drug therapies will include oxygen saturation therapy (oxygen supplementation) and pulmonary rehabilitation.
- Active listing (or expected future listing) for transplant of any organ.
- Clinically important abnormal screening laboratory values, including but not limited to: hemoglobin <8 g/dl, white blood cell count <3000/mm3, platelets <80,000/mm3, INR > 1.5, aspartate transaminase, alanine transaminase, or alkaline phosphatase > 3 times upper limit of normal, total bilirubin > 1.5 mg/dl.
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- Serious comorbid illness that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study. Including, but not limited to: HIV, advanced liver or renal failure, class III/IV congestive heart failure, myocardial infarction, unstable angina, or cardiac revascularization within the last six months, or severe obstructive ventilatory defect.
- Any other condition that, in the opinion of the investigator, may compromise the safety or compliance of the patient or preclude successful completion of the study.
- Have known allergies to penicillin or streptomycin.
- Be an organ transplant recipient.
- Have a clinical history of malignancy within 5 years (i.e., patients with prior malignancy must be disease free for 5 years), except curatively- treated basal cell carcinoma, squamous cell carcinoma, or cervical carcinoma.
- Have a non-pulmonary condition that limits lifespan to less than 1 year.
- Have a history of drug or alcohol abuse within the past 24 months.
- Be serum positive for Human immunodeficiency virus (HIV), hepatitis BsAg or Viremic hepatitis C.
- Be currently participating (or participated within the previous 30 days) in an investigational therapeutic or device trial.
- Be a female who is pregnant, nursing, or of childbearing potential while not practicing effective contraceptive methods. Female patients must undergo a blood or urine pregnancy test at screening and within 36 hours prior to injection.
- Female subjects must have a FSH less than 25.8 IU/L
- Subject with hypersensitivity to dimethyl sulfoxide (DMSO)
- Saturated oxygen (SpO2 of less than 93% (room air [sea level] at rest). SpO2 of less than 88% (room air [>5,000 feet above sea level (1524 meters) at rest).
Trial locations and contacts
1 site in 1 country.
United States1 site
Interdisciplinary Stem Cell Institute / University of Miami
Miami, Florida, 33136
About this study
Official title: A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary Fibrosis
This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will receive either allogenic mesenchymal stem cells or matched placebo.
Read the detailed description
Idiopathic Pulmonary Fibrosis (IPF) is a progressive and debilitating lung disease characterized by interstitial fibrosis with decreasing lung volumes and pulmonary insufficiency eventually resulting in death. Patients with Idiopathic Pulmonary Fibrosis (IPF) typically present with complaints of sub acutely progressive dyspnea and non-productive cough, often accompanied by digital clubbing. Due to the insidious onset of symptoms, however, most patients are diagnosed at late stages of the disease after significant fibrosis has occurred. Physical exam is characterized by hypoxemia, "dry" inspiratory crackles on auscultation, and occasional digital clubbing (6). Pulmonary function tests (PFTs) usually reveal restrictive lung physiology with progressive decline of forced vital capacity (FVC), diffusion capacity (DLCO) and six-minute walk distances. Diagnosis is established by the pathologic finding of usual interstitial pneumonia (with sub epithelial fibroblastic foci) by open lung biopsy (7), and/or by high resolution CT (HRCT) demonstrating the characteristic findings of peripheral/basal sub pleural reticulonodular changes with fibrosis, honeycombing, and traction bronchiectasis (8, 9).
The prognosis for patients with Idiopathic Pulmonary Fibrosis (IPF) is uniformly poor. The natural history of the disease is characterized by inexorable progressive decline interspersed with "exacerbations" or periods of accelerated disease which are often fatal (5). There are no FDA approved treatment options for patients with Idiopathic Pulmonary Fibrosis (IPF) and thus no standard of care. In cases of patients under the age of 60 with limited comorbid disease, lung transplant may be offered. Patients with Idiopathic Pulmonary Fibrosis (IPF) receive empiric treatment, supportive care alone, and more recently, are offered enrollment in clinical trials.
The pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) is characterized by epithelial cell injury and activation with interstitial inflammation, fibroblast proliferation with extracellular matrix collagen deposition, and eventual loss of function. Because mesenchymal stem cells are known to home to sites of injury, inhibit inflammation, and contribute to epithelial tissue repair, their use has been suggested as a novel therapy for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Being tested
- Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs), matched placebo
- Keywords
- IPF, Pulmonary fibrosis
- Medical subject headings
- Idiopathic Pulmonary Fibrosis, Pulmonary Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)Biological
matched placeboBiological
The placebo will be 25 ml of Plasma-Lyte A with 1% HSA in a Cryostore bag.
| Study group | Role | What they receive |
|---|---|---|
| 20 million hMSCs | Experimental | Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 2 x10^6 (20 million) cells delivered via peripheral intravenous infusion Receives: Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) |
| Placebo | Placebo comparator | Patients will receive a matched placebo delivered via peripheral intravenous infusion Receives: Biological: matched placebo |
| 100 million hMSCs | Experimental | Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 100 x10^6 (20 million) cells delivered via peripheral intravenous infusion Receives: Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) |
| 200 million hMSCs | Experimental | Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 200 x10^6 (200 million) cells delivered via peripheral intravenous infusion Receives: Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the safety and tolerability of intravenous allo hMSCs in patients with Idiopathic Pulmonary Fibrosis (IPF).
Safety (Primary): Incidence (one month post infusion) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
Measured: One month post infusion
Secondary outcomes (5)
- To explore effects of allo hMSCs on lung function: forced vital capacity (FVC).
- Difference in absolute decline of forced vital capacity (FVC) percent predicted.
Measured: Participants will be followed from 12 weeks to an expected average of 60 weeks following infusion.
To explore effects of allogenic human mesenchymal stem cells on symptom related quality of life.
- Quality of Life endpoint tools to be used include: University of California San Diego-Shortness of breath (UCSD-SOBQ), short form - 36 (SF-36), and St. George's respiratory questionnaire (SGRQ) questionnaires.
Measured: Participants will be followed from 4 weeks to an expected average of 60 weeks following infusion.
Difference in frequency of acute exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
Defined as:
- New or worsened dyspnea (<30 days).
- New ground glass opacities on High Resolution CT (HRCT) superimposed on chronic findings.
- New or worsened hypoxemia in the absence of other identifiable causes.
Measured: 4 weeks following infusion
Death from any cause.
Participants will be followed for the duration of the trial, which is an expected average of 60 weeks.
Measured: 60 weeks.
To explore effects of allogenic human mesenchymal stem cells on lung function: Diffusing Capacity (DLCO)
- Difference in absolute decline of Diffusing capacity (DLCO).
Measured: Participants will be followed from 12 weeks to an expected average of 60 weeks following infusion.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2013 (estimated)
- Study start13 Nov 2013
- Primary completion11 Dec 2015
- Study completion24 Nov 2016
Why it stopped: Study completed
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 Idiopathic Pulmonary Fibrosis (IPF)Studies 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
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Joshua M Hare
- Sponsor type
- University, hospital or other
- Collaborators
- The Lester And Sue Smith Foundation, The Emmes Company, LLC
- Responsible party
- Sponsor-investigator, Joshua M Hare, University of Miami
- Investigators
- Marilyn K. Glassberg, MD, Principal investigator, University of Miami
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02013700
- Sponsor's protocol ID
- 20120946
- Acronym
- AETHER
- Status last verified
- Mar 2021
- First submitted
- 2 Dec 2013
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.
PubMed 27890713
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Randomized, Blinded and Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Potential Efficacy of Allogeneic Human Mesenchymal Stem Cell Infusion in Patients With Idiopathic Pulmonary Fibrosis
- ClinicalTrials.gov ID
- NCT02013700
- Acronym / sponsor ID
- AETHER / 20120946
- Conditions
- Idiopathic Pulmonary Fibrosis (IPF)
- Keywords
- IPF, Pulmonary fibrosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Joshua M HareUniversity, hospital or other
- Collaborators
- The Lester And Sue Smith Foundation, The Emmes Company, LLC
- Study start
- 13 Nov 2013 (actual)
- Primary completion
- 11 Dec 2015 (actual)
- Study completion
- 24 Nov 2016 (actual)
- First posted
- 17 Dec 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.
This is a phase I, randomized, blinded, placebo-controlled 9 subjects pilot safety run-in followed by an additional 16 randomized subjects for a total of 25 subjects. In the pilot phase subjects will be randomized into three treatment groups of allogenic mesenchymal stem cells and in the randomized phase subjects will receive either allogenic mesenchymal stem cells or matched placebo.
Detailed description
Idiopathic Pulmonary Fibrosis (IPF) is a progressive and debilitating lung disease characterized by interstitial fibrosis with decreasing lung volumes and pulmonary insufficiency eventually resulting in death. Patients with Idiopathic Pulmonary Fibrosis (IPF) typically present with complaints of sub acutely progressive dyspnea and non-productive cough, often accompanied by digital clubbing. Due to the insidious onset of symptoms, however, most patients are diagnosed at late stages of the disease after significant fibrosis has occurred. Physical exam is characterized by hypoxemia, "dry" inspiratory crackles on auscultation, and occasional digital clubbing (6). Pulmonary function tests (PFTs) usually reveal restrictive lung physiology with progressive decline of forced vital capacity (FVC), diffusion capacity (DLCO) and six-minute walk distances. Diagnosis is established by the pathologic finding of usual interstitial pneumonia (with sub epithelial fibroblastic foci) by open lung biopsy (7), and/or by high resolution CT (HRCT) demonstrating the characteristic findings of peripheral/basal sub pleural reticulonodular changes with fibrosis, honeycombing, and traction bronchiectasis (8, 9).
The prognosis for patients with Idiopathic Pulmonary Fibrosis (IPF) is uniformly poor. The natural history of the disease is characterized by inexorable progressive decline interspersed with "exacerbations" or periods of accelerated disease which are often fatal (5). There are no FDA approved treatment options for patients with Idiopathic Pulmonary Fibrosis (IPF) and thus no standard of care. In cases of patients under the age of 60 with limited comorbid disease, lung transplant may be offered. Patients with Idiopathic Pulmonary Fibrosis (IPF) receive empiric treatment, supportive care alone, and more recently, are offered enrollment in clinical trials.
The pathogenesis of Idiopathic Pulmonary Fibrosis (IPF) is characterized by epithelial cell injury and activation with interstitial inflammation, fibroblast proliferation with extracellular matrix collagen deposition, and eventual loss of function. Because mesenchymal stem cells are known to home to sites of injury, inhibit inflammation, and contribute to epithelial tissue repair, their use has been suggested as a novel therapy for the treatment of Idiopathic Pulmonary Fibrosis (IPF).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 20 million hMSCs | Experimental | Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 2 x10^6 (20 million) cells delivered via peripheral intravenous infusion |
| Placebo | Placebo comparator | Biological: matched placeboPatients will receive a matched placebo delivered via peripheral intravenous infusion |
| 100 million hMSCs | Experimental | Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 100 x10^6 (20 million) cells delivered via peripheral intravenous infusion |
| 200 million hMSCs | Experimental | Biological: Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs)Patients will receive a single administration of Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs): 200 x10^6 (200 million) cells delivered via peripheral intravenous infusion |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Provide written informed consent.
- Subjects age equal to or greater than 40 and equal to or less than 90 years at the time of signing the Informed Consent Form.
- Have a clinical diagnosis of Idiopathic Pulmonary Fibrosis (IPF) prior to screening
- Forced vital capacity (FVC) ≥ 50% predicted and diffusing capacity (DLCO) ≥30% (corrected for hemoglobin but not alveolar volume).
- RVSP equal to or less than 50 mmHg, as documented by Doppler echo or right heart catheterization.
Key exclusion criteria (19 listed)
- HRCT and/or surgical lung biopsy results inconsistent with the diagnosis of IPF.
- Infiltrative lung disease of any type other than Idiopathic Pulmonary Fibrosis (IPF), lungs disease related to fibrogenic agents, toxins, drugs or other exposures, granulomatous lung disease, pulmonary vascular disease, or known connective tissue disease.
- Inability to perform any of the assessments required for endpoint analysis (report safety or tolerability concerns, perform pulmonary function tests or high resolution CT (HRCT), undergo blood draws, read and respond to questionnaires.
- Currently receiving (or received within four weeks of screening) any medication, treatment, or experimental agents for the treatment of Idiopathic Pulmonary Fibrosis (IPF), except for patients receiving non drug therapies will include oxygen saturation therapy (oxygen supplementation) and pulmonary rehabilitation.
- Active listing (or expected future listing) for transplant of any organ.
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 Adult Human Mesenchymal Stem Cells (hMSCs) | Biological | 100 million hMSCs, 20 million hMSCs, 200 million hMSCs |
| matched placeboThe placebo will be 25 ml of Plasma-Lyte A with 1% HSA in a Cryostore bag. | Biological | Placebo |
Primary outcome
To determine the safety and tolerability of intravenous allo hMSCs in patients with Idiopathic Pulmonary Fibrosis (IPF).
Time frame: One month post infusion
Safety (Primary): Incidence (one month post infusion) of any treatment-emergent serious adverse events (TE-SAEs), defined as the composite of: death, non-fatal pulmonary embolism, stroke, hospitalization for worsening dyspnea and clinically significant laboratory test abnormalities.
5 secondary outcomes
- To explore effects of allo hMSCs on lung function: forced vital capacity (FVC).
Time frame: Participants will be followed from 12 weeks to an expected average of 60 weeks following infusion.
To explore effects of allogenic human mesenchymal stem cells on symptom related quality of life.
Time frame: Participants will be followed from 4 weeks to an expected average of 60 weeks following infusion.
Difference in frequency of acute exacerbations of Idiopathic Pulmonary Fibrosis (IPF)
Time frame: 4 weeks following infusion
Death from any cause.
Time frame: 60 weeks.
To explore effects of allogenic human mesenchymal stem cells on lung function: Diffusing Capacity (DLCO)
Time frame: Participants will be followed from 12 weeks to an expected average of 60 weeks following infusion.
Results and safety
The study was stopped early (reason given: Study completed). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Background: PubMed 27890713Glassberg MK, Minkiewicz J, Toonkel RL, Simonet ES, Rubio GA, DiFede D, Shafazand S, Khan A, Pujol MV, LaRussa VF, Lancaster LH, Rosen GD, Fishman J, Mageto YN, Mendizabal A, Hare JM. Allogeneic Human Mesenchymal Stem Cells in Patients With Idiopathic Pulmonary Fibrosis via Intravenous Delivery (AETHER): A Phase I Safety Clinical Trial. Chest. 2017 May;151(5):971-981. doi: 10.1016/j.chest.2016.10.061. Epub 2016 Nov 24.
- Interdisciplinary Stem Cell Institute University of MiamiLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Marilyn K. Glassberg, MD principal investigator
University of Miami
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 Allogeneic Adult Human Mesenchymal Stem Cells (hMSCs) in people with Idiopathic Pulmonary Fibrosis (IPF), run by Joshua M Hare at 1 site 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 6 inclusion and 19 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: stopped early, as of the sponsor's last update on 9 Mar 2021. 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 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 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?
The study was stopped early (reason given: Study completed). Results are not available in the source record.
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?
To determine the safety and tolerability of intravenous allo hMSCs in patients with Idiopathic Pulmonary Fibrosis (IPF). (time frame: One month post infusion). 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 NCT02013700, 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 9 Mar 2021; AzTrials last refreshed its copy on 8 Nov 2026.