Normal PhysiologyPhase 1NCT02798523
Genomic Responses of Human Immune and Non-Immune Cells to Glucocorticoids
A Phase 1 study testing Methylprednisolone sodium succinate(Solu-Medrol) and Topical methylprednisolone (Advantan emulsion 0 /1%) in people with Normal Physiology, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.
Trial summary
Background: The immune system defends the body against bacteria and other harmful invaders. But it can overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs) can calm down an overactive immune system. But they often cause negative side effects. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Normal Physiology
- What is being tested?
- Methylprednisolone sodium succinate(Solu-Medrol) and Topical methylprednisolone (Advantan emulsion 0 /1%)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Jan 2017to 14 Nov 2022
- Phase
- Phase 1
- 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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 to 64 years
- Willingness to have samples stored for future research
- Willingness to undergo genetic testing
Who cannot join
- Body Mass Index less than 18 or greater than 35
- Difficult peripheral venous access (as determined by study staff at screening)
- History of severe allergic reaction to glucocorticoids
- History of autoimmune or autoinflammatory disease
- Active solid or hematologic malignancy
- History of a skin condition (such as psoriasis, pemphigus, or atopic dermatitis) that could affect the results of the transcriptional analysis of the skin biopsy samples
Show all 24Show fewer
- Diabetes mellitus
- Cancer chemotherapy within the past 5 years
- Surgery within the past 8 weeks
- History of recent (within the past 30 days) infection
- A positive test for human immunodeficiency virus, or hepatitis A, B or C virus infection (viral markers hepatitis screen, which includes HBsAg, anti-HCV IgG, anti-HAV IgM).
- A positive or indeterminate test for latent tuberculosis (interferon gamma release assay)
- History of parasitic, amebic, fungal or mycobacterial infections, or other possible latent infections
- Coagulation test (PT and PTT) results outside of normal range
- History of a bleeding disorder
- Use of a glucocorticoid (including topical or inhaled), a nonsteroidal anti-inflammatory drug (including aspirin), an anti-epileptic drug, an anticoagulant, a statin, fluoxetine, diltiazem, amiodarone, clarithromycin, ketoconazole, or St. John s wort, within the past 30 days
- Vaccination within the past 30 days
- Receipt of an immunosuppressant or immunomodulatory drug within the past 30 days
- Pregnancy, current or within the past 90 days, or trying to become pregnant during the study
- Current breastfeeding
- Complete blood count (CBC) and/or acute care panel values are both outside of the NIH Department of Laboratory Medicine normal reference range and deemed clinically significant by the principal investigator
- Any Electrocardiogram (ECG) abnormality that is clinically significant
- Any condition that, in the investigator s opinion, may put the participant at undue risk or compromise the study s scientific objectives
- Participation in a clinical protocol which includes an intervention that, in the opinion of the investigator, may affect the results of the current study
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids
Background:
The immune system defends the body against bacteria and other harmful invaders. But it can overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs) can calm down an overactive immune system. But they often cause negative side effects. Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the body. They tell our cells how to function. Researchers hope the results of this study will show them how to develop better drugs that will have the benefits of GCs without the side effects.
Read more
Objectives:
To study how human genes respond to glucocorticoid drugs.
Eligibility:
Healthy adult volunteers ages 18-64.
Design:
Participants will be screened with a medical history and physical exam. They will have a heart test and blood tests.
The study visit will last about 6 hours.
Participants will have medical history, physical exam, and 3 blood draws.
Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool will remove a piece of skin about as big as a pencil eraser.
A GC cream will be applied to the other arm.
Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip through a needle placed in an arm vein.
Participants will have a skin biopsy of the arm that had the cream applied.
Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions or other health problems.
Read the detailed description
Glucocorticoids are among the most frequently prescribed immunosuppressive and anti-inflammatory medications worldwide. Long-term use, however, is complicated by serious non-immunologic side effects. Ongoing in vitro experiments with human primary cells in our laboratory suggest that there are indeed fundamental differences in the genomic response of immune and non-immune cells to glucocorticoids. These and other aspects of drug action at the genomic level have not been completely characterized. This study will attempt to generate a list of human genes and non-coding RNAs that are differentially expressed and regulated in response to glucocorticoids between immune and non-immune cells. These data will be used to identify transcripts, their corresponding proteins, and the molecular pathways that are best candidates for targeted intervention. Potential targets could be validated with small interfering RNA (siRNA) libraries, with the long-term goal of developing small-molecule or nanoparticle-facilitated RNA interference (RNAi) interventions that reproduce the therapeutic action of glucocorticoids in immune cells while avoiding their harmful side effects on other tissues.
Healthy volunteers will undergo baseline blood collection prior to receiving a single intravenous dose of 250 milligrams of methylprednisolone sodium succinate. Blood will be collected in one of two regimens: 1 and 2 hours or 2 and 4 hours after the start of the infusion. A skin punch biopsy may be obtained before healthy volunteers receive IV methylprednisolone. If so, topical methylprednisolone will be applied to a limited area of skin, contralateral to the site of the baseline skin biopsy, and an additional skin biopsy will be obtained 4 hours after drug administration, from the area where topical methylprednisolone was applied. Follow-up phone calls 1 day and 1 week after discharge will document any adverse effects related to the drug or skin biopsy. Total length of individual study participation is 1-5 weeks.
Blood samples will be processed for isolation of hematopoietic cell sub-population (neutrophils, B cells, CD4+ T cells, CD8+ T cells, monocytes, and natural killer [NK] cells). Laboratory studies will be performed in the purified cells, with the goal of understanding the human response to glucocorticoids in vivo at the level of RNA (e.g., RNA sequencing, small -RNA-sequencing, real-time PCR), DNA (e.g., ChIP-seq, methylation analysis, DNA sequencing, genotyping, and protein (e.g., flow cytometry, mass spectrometry). At each time point, serum methylprednisolone levels will be measured and flow cytometry for standard lineage markers will be performed. Skin biopsies will be subjected to RNA isolation for RNA sequencing and small-RNA sequencing. A fragment of each skin biopsy will undergo fibroblast isolation and culture for in vitro exposure to glucocorticoids and for the generation of induced pluripotent stem (iPS) cells.
- Conditions
- Normal Physiology
- Being tested
- Methylprednisolone sodium succinate(Solu-Medrol), Topical methylprednisolone (Advantan emulsion 0 /1%)
- Keywords
- Methylprednisolone, Immunologic, Glucocorticoids, Functional genomics, RNA, Steroids
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone sodium succinate(Solu-Medrol)Drug
Methylprednisolone sodium succinate for injection, USP (SOLU-MEDROL sterile powder, Pfizer, Inc.) is an anti-inflammatory glucocorticoid which occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone.
125-milligram Act-O-Vial (AOV) System: Each 2 mL AOV (when mixed) contains methylprednisolone sodium succinate equivalent to 125 milligrams methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried.
Topical methylprednisolone (Advantan emulsion 0 /1%)Drug
1 g Advantan emulsion 0.1% (Bayer) contains methylprednisolone aceponate (21-acetoxy-11beta-hydroxy-6alpha-methyl-17-propionyloxy-1,4-pregnadiene-3,20-dione) 1 mg, as the active ingredient. It is an oil-in-water emulsion containing medium chain triglycerides, caprylic-capric-stearic triglyceride, polyoxyethylene alcohol 2-stearyl ether, polyoxyethylene alcohol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol, and purified water.
| Study group | Role | What they receive |
|---|---|---|
| Up to 2 hours post infusion | Experimental | Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between one to two hours after the start of the infusion. Receives: Drug: Methylprednisolone sodium succinate(Solu-Medrol) |
| Up to 4 hours post infusion | Experimental | Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between two hours to four hours after the start of the infusion. Receives: Drug: Methylprednisolone sodium succinate(Solu-Medrol); Drug: Topical methylprednisolone (Advantan emulsion 0 /1%) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types.
Measured: Up to 2 or 4 hours post infusion depending on group
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2016 (estimated)
- Study start24 Jan 2017
- Primary completion31 May 2022
- Study completion14 Nov 2022
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 Normal PhysiologyStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Luis M Franco, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02798523
- Sponsor's protocol ID
- 160126
- Other IDs
- 16-I-0126
- Status last verified
- 14 Nov 2022
- First submitted
- 10 Jun 2016
- Last updated
- 22 Jun 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Khoury P, Stokes K, Gadkari M, Makiya MA, Legrand F, Hu Z, Klion A, Franco LM. Glucocorticoid-induced eosinopenia in humans can be linked to early transcriptional events. Allergy. 2018 Oct;73(10):2076-2079. doi: 10.1111/all.13497. Epub 2018 Jul 17. No abstract available.
PubMed 29885264Franco LM, Gadkari M, Howe KN, Sun J, Kardava L, Kumar P, Kumari S, Hu Z, Fraser IDC, Moir S, Tsang JS, Germain RN. Immune regulation by glucocorticoids can be linked to cell type-dependent transcriptional responses. J Exp Med. 2019 Feb 4;216(2):384-406. doi: 10.1084/jem.20180595. Epub 2019 Jan 23.
PubMed 30674564Gadkari M, Makiya MA, Legrand F, Stokes K, Brown T, Howe K, Khoury P, Hu Z, Klion A, Franco LM. Transcript- and protein-level analyses of the response of human eosinophils to glucocorticoids. Sci Data. 2018 Dec 4;5:180275. doi: 10.1038/sdata.2018.275.
PubMed 30512017Hong SG, Sato N, Legrand F, Gadkari M, Makiya M, Stokes K, Howe KN, Yu SJ, Linde NS, Clevenger RR, Hunt T, Hu Z, Choyke PL, Dunbar CE, Klion AD, Franco LM. Glucocorticoid-induced eosinopenia results from CXCR4-dependent bone marrow migration. Blood. 2020 Dec 3;136(23):2667-2678. doi: 10.1182/blood.2020005161.
PubMed 32659786
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genomic Response of Human Immune and Non-Immune Cells to Glucocorticoids
- ClinicalTrials.gov ID
- NCT02798523
- Acronym / sponsor ID
- 160126
- Conditions
- Normal Physiology
- Keywords
- Methylprednisolone, Immunologic, Glucocorticoids, Functional genomics, RNA, Steroids
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 24 Jan 2017 (actual)
- Primary completion
- 31 May 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 14 Jun 2016 (estimated)
- Results
- Posted 22 Jun 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Background:
The immune system defends the body against bacteria and other harmful invaders. But it can overact and attack healthy cells by mistake. The group of drugs called glucocorticoids (GCs) can calm down an overactive immune system. But they often cause negative side effects. Researchers want to learn how human genes respond to GCs. Genes live inside each cell of the body. They tell our cells how to function. Researchers hope the results of this study will show them how to develop better drugs that will have the benefits of GCs without the side effects.
Objectives:
To study how human genes respond to glucocorticoid drugs.
Eligibility:
Healthy adult volunteers ages 18-64.
Design:
Participants will be screened with a medical history and physical exam. They will have a heart test and blood tests.
The study visit will last about 6 hours.
Participants will have medical history, physical exam, and 3 blood draws.
Participants will have a skin biopsy. An injection will numb the skin on one arm. Then a tool will remove a piece of skin about as big as a pencil eraser.
A GC cream will be applied to the other arm.
Participants will get the GC study drug for 30 minutes. It will be a liquid that will drip through a needle placed in an arm vein.
Participants will have a skin biopsy of the arm that had the cream applied.
Participants will have follow-up calls 1 and 4 days later. They will be asked about reactions or other health problems.
Detailed description
Glucocorticoids are among the most frequently prescribed immunosuppressive and anti-inflammatory medications worldwide. Long-term use, however, is complicated by serious non-immunologic side effects. Ongoing in vitro experiments with human primary cells in our laboratory suggest that there are indeed fundamental differences in the genomic response of immune and non-immune cells to glucocorticoids. These and other aspects of drug action at the genomic level have not been completely characterized. This study will attempt to generate a list of human genes and non-coding RNAs that are differentially expressed and regulated in response to glucocorticoids between immune and non-immune cells. These data will be used to identify transcripts, their corresponding proteins, and the molecular pathways that are best candidates for targeted intervention. Potential targets could be validated with small interfering RNA (siRNA) libraries, with the long-term goal of developing small-molecule or nanoparticle-facilitated RNA interference (RNAi) interventions that reproduce the therapeutic action of glucocorticoids in immune cells while avoiding their harmful side effects on other tissues.
Healthy volunteers will undergo baseline blood collection prior to receiving a single intravenous dose of 250 milligrams of methylprednisolone sodium succinate. Blood will be collected in one of two regimens: 1 and 2 hours or 2 and 4 hours after the start of the infusion. A skin punch biopsy may be obtained before healthy volunteers receive IV methylprednisolone. If so, topical methylprednisolone will be applied to a limited area of skin, contralateral to the site of the baseline skin biopsy, and an additional skin biopsy will be obtained 4 hours after drug administration, from the area where topical methylprednisolone was applied. Follow-up phone calls 1 day and 1 week after discharge will document any adverse effects related to the drug or skin biopsy. Total length of individual study participation is 1-5 weeks.
Blood samples will be processed for isolation of hematopoietic cell sub-population (neutrophils, B cells, CD4+ T cells, CD8+ T cells, monocytes, and natural killer [NK] cells). Laboratory studies will be performed in the purified cells, with the goal of understanding the human response to glucocorticoids in vivo at the level of RNA (e.g., RNA sequencing, small -RNA-sequencing, real-time PCR), DNA (e.g., ChIP-seq, methylation analysis, DNA sequencing, genotyping, and protein (e.g., flow cytometry, mass spectrometry). At each time point, serum methylprednisolone levels will be measured and flow cytometry for standard lineage markers will be performed. Skin biopsies will be subjected to RNA isolation for RNA sequencing and small-RNA sequencing. A fragment of each skin biopsy will undergo fibroblast isolation and culture for in vitro exposure to glucocorticoids and for the generation of induced pluripotent stem (iPS) cells.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Up to 2 hours post infusion | Experimental | Drug: Methylprednisolone sodium succinate(Solu-Medrol)Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between one to two hours after the start of the infusion. |
| Up to 4 hours post infusion | Experimental | Drug: Methylprednisolone sodium succinate(Solu-Medrol), Drug: Topical methylprednisolone (Advantan emulsion 0 /1%)Healthy volunteers received a single intravenous dose of 250 mg of methylprednisolone and blood was collected between two hours to four hours after the start of the infusion. |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
Key exclusion criteria (24 listed)
- Body Mass Index less than 18 or greater than 35
- Difficult peripheral venous access (as determined by study staff at screening)
- History of severe allergic reaction to glucocorticoids
- History of autoimmune or autoinflammatory disease
- Active solid or hematologic malignancy
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 |
|---|---|---|
| Methylprednisolone sodium succinate(Solu-Medrol)Methylprednisolone sodium succinate for injection, USP (SOLU-MEDROL sterile powder, Pfizer, Inc.) is an anti-inflammatory glucocorticoid which occurs as a white, or nearly white, odorless hygroscopic, amorphous solid. It is very soluble in water and in alcohol; it is insoluble in chloroform and is very slightly soluble in acetone. 125-milligram Act-O-Vial (AOV) System: Each 2 mL AOV (when mixed) contains methylprednisolone sodium succinate equivalent to 125 milligrams methylprednisolone; also 1.6 mg monobasic sodium phosphate anhydrous; and 17.4 mg dibasic sodium phosphate dried. | Drug | Up to 2 hours post infusion, Up to 4 hours post infusion |
| Topical methylprednisolone (Advantan emulsion 0 /1%)1 g Advantan emulsion 0.1% (Bayer) contains methylprednisolone aceponate (21-acetoxy-11beta-hydroxy-6alpha-methyl-17-propionyloxy-1,4-pregnadiene-3,20-dione) 1 mg, as the active ingredient. It is an oil-in-water emulsion containing medium chain triglycerides, caprylic-capric-stearic triglyceride, polyoxyethylene alcohol 2-stearyl ether, polyoxyethylene alcohol-21-stearyl ether, benzyl alcohol, disodium edetate, glycerol, and purified water. | Drug | Up to 4 hours post infusion |
Primary outcome
Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates)
Time frame: Up to 2 or 4 hours post infusion depending on group
Number of participants (biological replicates) that were successfully sampled for RNA-seq differential gene expression analysis in glucocorticoid-treated immune cells. The analysis employed a cutoff value of < 5% false-discovery rate (FDR) to select the transcripts that were considered differentially expressed at each time point. The resulting gene lists were contrasted to determine which genes were uniquely differentially expressed in different cell types.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 29885264Khoury P, Stokes K, Gadkari M, Makiya MA, Legrand F, Hu Z, Klion A, Franco LM. Glucocorticoid-induced eosinopenia in humans can be linked to early transcriptional events. Allergy. 2018 Oct;73(10):2076-2079. doi: 10.1111/all.13497. Epub 2018 Jul 17. No abstract available.
- Background: PubMed 30674564Franco LM, Gadkari M, Howe KN, Sun J, Kardava L, Kumar P, Kumari S, Hu Z, Fraser IDC, Moir S, Tsang JS, Germain RN. Immune regulation by glucocorticoids can be linked to cell type-dependent transcriptional responses. J Exp Med. 2019 Feb 4;216(2):384-406. doi: 10.1084/jem.20180595. Epub 2019 Jan 23.
- Background: PubMed 30512017Gadkari M, Makiya MA, Legrand F, Stokes K, Brown T, Howe K, Khoury P, Hu Z, Klion A, Franco LM. Transcript- and protein-level analyses of the response of human eosinophils to glucocorticoids. Sci Data. 2018 Dec 4;5:180275. doi: 10.1038/sdata.2018.275.
- Derived from this study: PubMed 32659786Hong SG, Sato N, Legrand F, Gadkari M, Makiya M, Stokes K, Howe KN, Yu SJ, Linde NS, Clevenger RR, Hunt T, Hu Z, Choyke PL, Dunbar CE, Klion AD, Franco LM. Glucocorticoid-induced eosinopenia results from CXCR4-dependent bone marrow migration. Blood. 2020 Dec 3;136(23):2667-2678. doi: 10.1182/blood.2020005161.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
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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.
Luis M Franco, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
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 Methylprednisolone sodium succinate(Solu-Medrol) and Topical methylprednisolone (Advantan emulsion 0 /1%) in people with Normal Physiology, run by National Institute of Allergy and Infectious Diseases (NIAID) 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 3 inclusion and 24 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 22 Jun 2023. 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. 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?
Yes. Results are posted in the registry (first posted 22 Jun 2023). 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?
Number of Participants Sampled for RNA-seq Differential Expression Analysis (Biological Replicates) (time frame: Up to 2 or 4 hours post infusion depending on group). 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 NCT02798523, 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 22 Jun 2023.