Diabetes MellitusPhase 1/2MSCTXT1DMNCT04078308
Mesenchymal Stem Cells Transplantation in Newly Diagnosed Type-1 Diabetes Patients
A Phase 1/2 study testing Intravenous Injection of autologous mesenchymal stem cells in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Royan Institute at 1 site in Iran.
Trial summary
Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving regeneration. Read more about this study
- Who is it for?
- Ages 8 to 40 years
- Conditions the study is for
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Diabetes Mellitus, Insulin-Dependent
- What is being tested?
- Intravenous Injection of autologous 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 siteIran
- Study dates
- 6 Jul 2015to 1 Apr 2020
- 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 8 to 40 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Type 1 diabetes detection in less than 6 weeks
- Diabetes diagnosis according to American Diabetes Association (ADA)
- Presence of Antibodies against pancreatic beta cells
- Fasting C-peptide ≥ 0.3 ng/ml
Who cannot join
- Pregnancy or breastfeeding
- Cancer
- Any acute or severe disease (According to physicians' diagnosis: such as cardiac, pulmonary, hepatic, kidney, mental, … diseases)
- Positive results for: Human Immunodeficiency Virus (HIV), Human T-Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Cytomegalovirus (CMV)
- Immune deficient or hyper aesthesia
- History of severe ketoacidosis
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase I/II Clinical Trial to Examine the Safety and Efficacy of Transplantation of Mesenchymal Stem Cells in New-onset Type 1 Diabetes Patients
Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving regeneration. Study design and method: In a Triple blinded randomized placebo-controlled phase I/II clinical trial, 20 patients with newly diagnosed type-1 diabetes who would be visited in Children's Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group and the placebo group. Participants: Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. Interventions: Intravascular transplantation of autologous mesenchymal stem cells in the case group; placebo injection in the control group. Outcome variables: safety and efficacy.
Read the detailed description
Diabetes is an autoimmune disease which is mainly caused by an immune reaction to beta cells in the pancreas. Today, insulin injection is a routine treatment for diabetes. Although injected insulin maintains blood glucose, this method cannot result in physiologic reaction to blood glucose changes. Moreover, patients are encountered with diabetes complications like neuropathy, nephropathy, visual and cardiovascular problems, and hypoglycemic unawareness. Therefore, based on previous studies, a treatment option that leads to pancreatic beta cell restoration and inhibits the immune response to these cells could be a hopeful clinical choice. In this clinical trial, autologous bone marrow-derived mesenchymal stem cells will be used for immune response modulation and improving regeneration. Hence, based on inclusion and exclusion criteria, 20 patients with type-1 diabetes will be selected and after clarifying the procedure and fulfilling the agreement to participate in this trial, they will be sorted in two groups. Bone marrow is aspirated from patients bone and after isolation of Mesenchymal stem cells and characterization of these cells, patients in case group will be intravenously injected by 1 million autologous mesenchymal stem cells per kg of patient's body weight in each dose in week 0 and 3, whereas the control group receives a placebo. Then patients will be followed up for 1 year. During this time, different parameters would be evaluated in weeks 1, 2,4, and Months 2,3,6,9 and 12. Laboratory screenings will be done during this period to evaluate the safety and efficacy of this treatment.
- Being tested
- Intravenous Injection of autologous mesenchymal stem cells, Intravenous injection of placebo
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Cell Transplantation, Autologous Transplantation, Mesenchymal Stem Cell
- Medical subject headings
- Diabetes Mellitus, Diabetes Mellitus, Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous Injection of autologous mesenchymal stem cellsBiological
Intravenous injection 1 millions of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) per kg of patient's body weight in each dose, weeks 0 \& 3
Intravenous injection of placeboOther
Intravenous injection of normal saline (sodium chloride 0.9%)
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stem Cells Transplantation | Experimental | The patients with Type 1 Diabetes, who will receive Intravenous injection of autologous bone-marrow derived mesenchymal stem cells Receives: Biological: Intravenous Injection of autologous mesenchymal stem cells |
| Placebo | Placebo comparator | The patients with Type 1 Diabetes, who will receive intravenous injection of normal saline (sodium chloride 0.9%) Receives: Other: Intravenous injection of placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Safety will be assessed by evaluating patients based on CTCAE (v.5) to assess treatment-related adverse events after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Measured: 12 months after the first infusion
Change from baseline number of hypoglycemic Unawareness episodes at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Number of hypoglycemic unawareness episodes will be assessed by evaluating patients' blood glucose monitoring sheets
Measured: 12 months after the first infusion
Secondary outcomes (10)
Change from Baseline Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline Fasting Blood Sugar (FBS)
Measured: 12 months after the first infusion
Change from Baseline C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing serum C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline serum C-peptide level
Measured: 12 months after the first infusion
Change from Baseline HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline HbA1C
Measured: 12 months after the first infusion
Change from Baseline 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells and compare the results with baseline 2-hour postprandial blood glucose
Measured: 12 months after the first infusion
Change from Baseline daily dose of exogenous insulin injected by patients (IU/kg/day) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Exogenous Insulin requirement of patients will be measured based on their daily insulin injection report sheets, total injected insulin units per day will be divided by patient's weight in order to be comparable between different patients.
Measured: 12 months after the first infusion
Change from baseline Lability Index (LI) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing 2 weeks of blood glucose report sheets, calculation is based on the changes in blood glucose levels over time
Measured: 12 months after the first infusion
Change from Baseline SF-36 Quality of life (QOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing change in patients' Quality of life by answering SF-36 questionnaire before transplantation and 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells; This questionnaire asks about general aspects of patients' life.
The results would be reported as the total score and the scale range is from 0% to 100%. 0% is considered as worse condition and 100% is considered as the best condition.
Measured: 12 months after the first infusion
Change from Baseline Diabetes Specific Quality of life (DQOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing change in patients' Quality of life by answering Diabetes Specific Quality of Life (DQOL) questionnaire before transplantation and 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells; This questionnaire asks about different aspects of patients' life in relation to diabetes.
The results would be reported as the total score and the scale range is from 0% to 100%. 0% is considered as worse condition and 100% is considered as the best condition.
Measured: 12 months after the first infusion
Changes from baseline Autoantibodies levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing patients Islet Cell Antibodies (ICA), Glutamic Acid Decarboxylase Antibodies (GADA), Insulinoma-Associated protein-2 Antibodies (IA-2A) levels after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Measured: 12 months after the first infusion
Changes from baseline serum cytokines levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Assessing serum cytokines levels of patients after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Measured: 12 months after the first infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2019
- Study start6 Jul 2015
- Primary completion26 Sep 2019 (estimated)
- Study completion1 Apr 2020 (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 Diabetes MellitusStudies 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royan Institute
- Sponsor type
- Other government
- Collaborators
- Tehran University of Medical Sciences, Iranian Stem Cell Council
- Responsible party
- Sponsor
- Investigators
- Abdolhossein Shahverdi, PhD, Study chair, Royan Institute, ACECR, Tehran, I.R. IranHossein Baharvand, PhD, Study director, Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, ACECR, Tehran, I.R. IranAli Rabbani, MD, Study director, Tehran University of Medical Sciences, Tehran, I.R. IranEnsiyeh Hajizadeh saffar, MD,PhD, Principal investigator, Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, ACECR, Tehran, I.R. Iran
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04078308
- Sponsor's protocol ID
- RI-SCBT-94000019
- Other IDs
- IRCT2016070428786N1, 94000019, REP-441
- Acronym
- MSCTXT1DM
- Status last verified
- Sep 2019
- First submitted
- 24 Jun 2019
- Last updated
- 6 Sep 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Izadi M, Sadr Hashemi Nejad A, Moazenchi M, Masoumi S, Rabbani A, Kompani F, Hedayati Asl AA, Abbasi Kakroodi F, Jaroughi N, Mohseni Meybodi MA, Setoodeh A, Abbasi F, Hosseini SE, Moeini Nia F, Salman Yazdi R, Navabi R, Hajizadeh-Saffar E, Baharvand H. Mesenchymal stem cell transplantation in newly diagnosed type-1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial. Stem Cell Res Ther. 2022 Jun 20;13(1):264. doi: 10.1186/s13287-022-02941-w.
PubMed 35725652
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I/II Clinical Trial to Examine the Safety and Efficacy of Transplantation of Mesenchymal Stem Cells in New-onset Type 1 Diabetes Patients
- ClinicalTrials.gov ID
- NCT04078308
- Acronym / sponsor ID
- MSCTXT1DM / RI-SCBT-94000019
- Keywords
- Diabetes Mellitus, Diabetes Mellitus, Type 1, Cell Transplantation, Autologous Transplantation, Mesenchymal Stem Cell
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Royan InstituteOther government
- Collaborators
- Tehran University of Medical Sciences, Iranian Stem Cell Council
- Study start
- 6 Jul 2015 (actual)
- Primary completion
- 26 Sep 2019 (estimated)
- Study completion
- 1 Apr 2020 (estimated)
- First posted
- 6 Sep 2019 (actual)
- 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.
Study Objects: Diabetes is an autoimmune disease which is mainly caused an immune reaction to beta cells in the pancreas. In this study, mesenchymal stem cells will be used for immune response modulation and improving regeneration. Study design and method: In a Triple blinded randomized placebo-controlled phase I/II clinical trial, 20 patients with newly diagnosed type-1 diabetes who would be visited in Children's Growth and Development Research Center of Tehran University of Medical Sciences and Royan Institute Cell Therapy Center, would be assessed through two groups including the case group and the placebo group. Participants: Patients of both sexes in a range of 8 to 40 years old who have been diagnosed to have type-1 diabetes in no more than 6 weeks, antibody against beta cells diagnosed in their blood, fasting c-peptide more than or equal to 0.3 ng/ml, and are not suffered from other acute or chronic diseases and cancers, would be studied. Interventions: Intravascular transplantation of autologous mesenchymal stem cells in the case group; placebo injection in the control group. Outcome variables: safety and efficacy.
Detailed description
Diabetes is an autoimmune disease which is mainly caused by an immune reaction to beta cells in the pancreas. Today, insulin injection is a routine treatment for diabetes. Although injected insulin maintains blood glucose, this method cannot result in physiologic reaction to blood glucose changes. Moreover, patients are encountered with diabetes complications like neuropathy, nephropathy, visual and cardiovascular problems, and hypoglycemic unawareness. Therefore, based on previous studies, a treatment option that leads to pancreatic beta cell restoration and inhibits the immune response to these cells could be a hopeful clinical choice. In this clinical trial, autologous bone marrow-derived mesenchymal stem cells will be used for immune response modulation and improving regeneration. Hence, based on inclusion and exclusion criteria, 20 patients with type-1 diabetes will be selected and after clarifying the procedure and fulfilling the agreement to participate in this trial, they will be sorted in two groups. Bone marrow is aspirated from patients bone and after isolation of Mesenchymal stem cells and characterization of these cells, patients in case group will be intravenously injected by 1 million autologous mesenchymal stem cells per kg of patient's body weight in each dose in week 0 and 3, whereas the control group receives a placebo. Then patients will be followed up for 1 year. During this time, different parameters would be evaluated in weeks 1, 2,4, and Months 2,3,6,9 and 12. Laboratory screenings will be done during this period to evaluate the safety and efficacy of this treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stem Cells Transplantation | Experimental | Biological: Intravenous Injection of autologous mesenchymal stem cellsThe patients with Type 1 Diabetes, who will receive Intravenous injection of autologous bone-marrow derived mesenchymal stem cells |
| Placebo | Placebo comparator | Other: Intravenous injection of placeboThe patients with Type 1 Diabetes, who will receive intravenous injection of normal saline (sodium chloride 0.9%) |
Who may qualify
- Ages
- 8 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Type 1 diabetes detection in less than 6 weeks
- Diabetes diagnosis according to American Diabetes Association (ADA)
- Presence of Antibodies against pancreatic beta cells
- Fasting C-peptide ≥ 0.3 ng/ml
Key exclusion criteria (6 listed)
- Pregnancy or breastfeeding
- Cancer
- Any acute or severe disease (According to physicians' diagnosis: such as cardiac, pulmonary, hepatic, kidney, mental, … diseases)
- Positive results for: Human Immunodeficiency Virus (HIV), Human T-Lymphotropic Virus (HTLV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Cytomegalovirus (CMV)
- Immune deficient or hyper aesthesia
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 |
|---|---|---|
| Intravenous Injection of autologous mesenchymal stem cellsIntravenous injection 1 millions of bone-marrow derived autologous Mesenchymal Stem Cells (MSCs) per kg of patient's body weight in each dose, weeks 0 \& 3 | Biological | Mesenchymal Stem Cells Transplantation |
| Intravenous injection of placeboIntravenous injection of normal saline (sodium chloride 0.9%) | Other | Placebo |
Primary outcome
Number of participants with treatment-related adverse events as assessed by CTCAE v5.0
Time frame: 12 months after the first infusion
Safety will be assessed by evaluating patients based on CTCAE (v.5) to assess treatment-related adverse events after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Change from baseline number of hypoglycemic Unawareness episodes at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Number of hypoglycemic unawareness episodes will be assessed by evaluating patients' blood glucose monitoring sheets
10 secondary outcomes
Change from Baseline Fasting Blood Sugar (FBS) at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline C-peptide at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline HbA1C at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline 2-hour postprandial blood glucose at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline daily dose of exogenous insulin injected by patients (IU/kg/day) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from baseline Lability Index (LI) at 12 Months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline SF-36 Quality of life (QOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Change from Baseline Diabetes Specific Quality of life (DQOL) questionnaire score at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Changes from baseline Autoantibodies levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Changes from baseline serum cytokines levels in patients' blood at 12 months after intravenous transplantation of autologous bone marrow derived Mesenchymal Stem Cells
Time frame: 12 months after the first infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2019.
- Derived from this study: PubMed 35725652Izadi M, Sadr Hashemi Nejad A, Moazenchi M, Masoumi S, Rabbani A, Kompani F, Hedayati Asl AA, Abbasi Kakroodi F, Jaroughi N, Mohseni Meybodi MA, Setoodeh A, Abbasi F, Hosseini SE, Moeini Nia F, Salman Yazdi R, Navabi R, Hajizadeh-Saffar E, Baharvand H. Mesenchymal stem cell transplantation in newly diagnosed type-1 diabetes patients: a phase I/II randomized placebo-controlled clinical trial. Stem Cell Res Ther. 2022 Jun 20;13(1):264. doi: 10.1186/s13287-022-02941-w.
- Royan Stem Cell webpageLink provided by the sponsor.
- Royan Institute webpageLink provided by the sponsor.
- 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.
Abdolhossein Shahverdi, PhD study chair
Royan Institute, ACECR, Tehran, I.R. Iran
Hossein Baharvand, PhD study director
Department of Stem Cells Biology and Technology, Cell Science Research Center, Royan Institute for Stem Cells Biology & Technology, ACECR, Tehran, I.R. Iran
Ali Rabbani, MD study director
Tehran University of Medical Sciences, Tehran, I.R. Iran
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 Intravenous Injection of autologous mesenchymal stem cells in people with Diabetes Mellitus and Diabetes Mellitus, Type 1, run by Royan Institute at 1 site in Iran.
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 4 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 6 Sep 2019. 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 Iran. 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 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?
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 with treatment-related adverse events as assessed by CTCAE v5.0 (time frame: 12 months after the first infusion). The study lists 2 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 NCT04078308, 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 6 Sep 2019.