GVHD, AcutePhase 22017-00355NCT04118556
Decidua Stroma Cells for Steroid Resistent Acute Graft-versus-host Disease After Allo-HSCT
A Phase 2 study testing Decidua Stroma Cells (DSC) and Best available Treatment (BAT) in people with GVHD, Acute, run by Mats Remberger at 4 sites in 3 countries.
Trial summary
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GVHD, Acute
- What is being tested?
- Decidua Stroma Cells (DSC) and Best available Treatment (BAT)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 4 sitesin 3 countries
- Study dates
- 1 Dec 2021to 29 Apr 2026
- Phase
- Phase 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.
- Signed written study informed consent once SR-aGvHD is confirmed.
Who cannot join
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
- Has received systemic treatment for aGvHD apart from steroids.
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome.
- Pregnant or lactating women.
- Significant respiratory disease.
- Presence of severely impaired renal function
Show all 16Show fewer
- Any corticosteroid therapy for indications other than aGvHD
- Previous participation in a study of any investigational treatment agent within 30 days
- Known human immunodeficiency virus infection (HIV).
- Patients suffering on active tuberculosis or viral hepatitis
- Significant respiratory disease
- Presence of severely impaired renal or liver function
- History of progressive multifocal leuko-encephalopathy
- Patients with coagulopathy
- History of severe chronic history of heart disease
- Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Trial locations and contacts
4 sites in 3 countries.
4 sites in 3 countries
Sweden2 sites
Lund University Hospital
Lund, SE-221 85
Uppsala University Hospital
Uppsala, SE-75185
About this study
Official title: A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem Cell Transplant Treated With DSC or BAT
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response.
No cross-over are planned in the second stage of the study.
Read the detailed description
Main inclusion criteria:
Adult patients (age ≥ 18 years) with steroid refractory (SR) acute GvHD (aGVHD) grades II-IV after allo-HSCT.
Signed written study informed consent once SR-aGvHD is confirmed.
Main exclusion criteria:
Presence of an active uncontrolled infection requiring treatment. Has received systemic treatment for aGvHD apart from steroids. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome. Known human immunodeficiency virus infection (HIV). Patients suffering on active tuberculosis or viral hepatitis. Significant respiratory disease Presence of severely impaired renal function Patients with coagulopathy Pregnant or nursing (lactating) women Malignancy that has required treatment in the previous two years Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Design:
The trial is a Phase II, randomized (1:1), open label study investigating the efficacy and safety of DSC vs. BAT added to the patient's immunosuppressive regimen in adults with SR-aGvHD.
The primary objectives will be safety and to compare durable overall response (DOR) at 56 days after randomization between patients receiving DSC with patients receiving BAT as treatment for SR acute GvHD grades II-IV. Target enrollment is 50 patients, 25 in the DSC treatment-arm and 25 in the BAT arm. Patients will be given the optimal dose of DSC from the Phase I, dose escalating part of the study, as mentioned above. At least 2 doses of DSC will be given one week apart. Additional doses of DSC (maximum 4 doses) may be given depending on response. Additional doses (beyond the first 2 doses) may be given one week apart until response, or whenever needed if aGVHD flare occur within 6 months after randomization (EOT).
BAT: Investigator's choice Best Available Therapy (BAT) will vary depending upon Investigator's choice identified prior to randomization. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
Primary objective
- Assess the Safety of DSC.
- Durable Overall Response (DOR) at Day 56.
Secondary objectives
- To assess Overall Response Rate (ORR) at day 28
- To assess 1-year Overall Survival (OS)
- To assess 1-year Non-Relapse Mortality (NRM)
- To assess incidence of infections
Exploratory objectives
- To assess the cumulative steroid dose until Day 56 and Day 90
- To assess Event-Free Survival (EFS)
- To assess incidence of Malignancy Relapse/Progression
- To measure the incidence of chronic GvHD
- To measure immune reconstitution
- To evaluate changes in Patient Reported Outcomes
- Conditions
- GVHD, Acute
- Being tested
- Decidua Stroma Cells (DSC), Best available Treatment (BAT)
- Keywords
- DSC, BAT, GVHD, HSCT
- Medical subject headings
- Graft vs Host Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decidua Stroma Cells (DSC)Biological
Placenta-derived Decidua Stroma Cells. The product consists of a viable allogeneic DSCs frozen in 5% of human serum albumin (HSA) in sodium chloride (NaCl) 0.9% and 10% dimethylsulfoxide (DMSO), that is thawed and immediately diluted in 40 mL sodium chloride (NaCl) 0.9% prior to infusion. That will give a final concentration of 2.2% HSA and 2% DMSO.
DSC will be infused when steroid-refractory acute GVHD after allogenic stem-cell transplantation has been diagnosed. Two doses, one week apart, will be given to all patients. Additional doses will be used depending on response.
Best available Treatment (BAT)Drug
Also called ECP, Everolimus, Sirolimus, Etanercept, Vedolizumab, Ruxolitinib, Infliximab.
The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
| Study group | Role | What they receive |
|---|---|---|
| Decidua Stroma Cells (DSC) | Experimental | Placenta derived decidua stroma cells (DSC). In the first phase I part, two different dose levels will be used, 1x10^6/kg and 3x10^6/kg. Two doses, one week apart, will be given. The decision to proceed to the next dose level will depend on results observed at the previous dose level.
The dose in the randomized part will be based on the findings in the phase I part. In the Phase II study all patients will receive 2 doses, one week apart. Depending on response, up to 6 doses in total may be given. Additional doses (beyond the first 2 doses) may be given one week apart until response. Receives: Biological: Decidua Stroma Cells (DSC) |
| Best Available Treatment (BAT) | Active comparator | The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT. Receives: Drug: Best available Treatment (BAT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety and tolerability evaluation including Severe Adverse Events (SAE).
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Measured: 5 years
Durable Response to treatment
Durable Overall Response (DOR) day 56.
Measured: 56 days
Secondary outcomes (8)
Number of patients with overall response (CR+PR) at day 28
Overall Response Rate (ORR) at day 28.
Measured: 28 days
Rate of Survival
Death within 1 year after inclusion in study.
Measured: 1 year
Incidence of Non-Relapse Mortality (NRM)
Death of any cause with enduring complete remission.
Measured: 1 year
Incidence of infections
Serious infections occurring after inclusion in study.
Measured: 1 year
Change of Quality of Life
Change of self-experienced well-being (Quality of Life)(FACT-BMT version 4) at four time-points after inclusion. Scoring procedures consist of summing the items with reversed scoring (0-4p where 0=best and 4=worst) for several items which produces individual subscale scores (0-24/28p) and an overall score (0-200p).
The FACT-BMT (Functional Assessment of Cancer Therapy-Bone Marrow Transplant) has a total of 50 questions. This is a questionnaire of general questions divided into four primary quality of life domains: physical well-being (PWB; 7-items), social/family well-being (SWB; 7-items), emotional well-being (EWB; 6-items); and functional well-being (FWB; 7-items), 18 items address the BMT related side effects, specifically designed to assess the BMT patients' quality of life. Five other questions from different QoL questionnaire were added as they were considered relevant to FACT-BMT.
Measured: 1 year
Incidence of Relapse
Recurrence of the disease the patient were transplanted for.
Measured: 5 year
Incidence of secondary malignancies
Occurrence of other malignancies than the patient were transplanted for.
Measured: 5 year
Incidence of chronic GVHD
Occurrence of chronic GVHD.
Measured: 5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2019
- Study start1 Dec 2021
- Primary completion29 Apr 2026
- Study completion29 Apr 2026
Why it stopped: Too slow recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for GVHD, AcuteStudies 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
- Model description
- A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.
- Masking
- None (open label)
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mats Remberger
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Sponsor-investigator, Mats Remberger, Uppsala University Hospital
- Investigators
- Mats Remberger, Professor, Study director, KFUE, Uppsala University Hospital, Uppsala, SwedenUlla Olsson-Strömberg, AssProfessor, Principal investigator, Dep of Hematology, Uppsala University Hospital, Uppsala, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04118556
- Sponsor's protocol ID
- DSC-BROMS-1
- Other IDs
- 2019-002186-36, 2019
- Acronym
- 2017-00355
- Status last verified
- Apr 2026
- First submitted
- 27 Sep 2019
- Last updated
- 6 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ringden O, Baygan A, Remberger M, Gustafsson B, Winiarski J, Khoein B, Moll G, Klingspor L, Westgren M, Sadeghi B. Placenta-Derived Decidua Stromal Cells for Treatment of Severe Acute Graft-Versus-Host Disease. Stem Cells Transl Med. 2018 Apr;7(4):325-331. doi: 10.1002/sctm.17-0167. Epub 2018 Mar 13.
PubMed 29533533Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4.
PubMed 31173898
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label, Randomized, Phase I/II Clinical Trial Comparing Safety and Durable Overall Response Day 56 in Patients With Steroid Resistent Acute GvHD After Allogeneic Hematopoietic Stem Cell Transplant Treated With DSC or BAT
- ClinicalTrials.gov ID
- NCT04118556
- Acronym / sponsor ID
- 2017-00355 / DSC-BROMS-1
- Conditions
- GVHD, Acute
- Keywords
- DSC, BAT, GVHD, HSCT
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Too slow recruitment
- Enrolment
- 12 participants (actual)
- Lead sponsor
- Mats RembergerUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 29 Apr 2026 (actual)
- Study completion
- 29 Apr 2026 (actual)
- First posted
- 8 Oct 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.
A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease in the second part of the study. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response.
No cross-over are planned in the second stage of the study.
Detailed description
Main inclusion criteria:
Adult patients (age ≥ 18 years) with steroid refractory (SR) acute GvHD (aGVHD) grades II-IV after allo-HSCT.
Signed written study informed consent once SR-aGvHD is confirmed.
Main exclusion criteria:
Presence of an active uncontrolled infection requiring treatment. Has received systemic treatment for aGvHD apart from steroids. Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome. Known human immunodeficiency virus infection (HIV). Patients suffering on active tuberculosis or viral hepatitis. Significant respiratory disease Presence of severely impaired renal function Patients with coagulopathy Pregnant or nursing (lactating) women Malignancy that has required treatment in the previous two years Any condition that would, in the Investigator's judgment, interfere with full participation in the study.
Design:
The trial is a Phase II, randomized (1:1), open label study investigating the efficacy and safety of DSC vs. BAT added to the patient's immunosuppressive regimen in adults with SR-aGvHD.
The primary objectives will be safety and to compare durable overall response (DOR) at 56 days after randomization between patients receiving DSC with patients receiving BAT as treatment for SR acute GvHD grades II-IV. Target enrollment is 50 patients, 25 in the DSC treatment-arm and 25 in the BAT arm. Patients will be given the optimal dose of DSC from the Phase I, dose escalating part of the study, as mentioned above. At least 2 doses of DSC will be given one week apart. Additional doses of DSC (maximum 4 doses) may be given depending on response. Additional doses (beyond the first 2 doses) may be given one week apart until response, or whenever needed if aGVHD flare occur within 6 months after randomization (EOT).
BAT: Investigator's choice Best Available Therapy (BAT) will vary depending upon Investigator's choice identified prior to randomization. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT.
Primary objective
- Assess the Safety of DSC.
- Durable Overall Response (DOR) at Day 56.
Secondary objectives
- To assess Overall Response Rate (ORR) at day 28
- To assess 1-year Overall Survival (OS)
- To assess 1-year Non-Relapse Mortality (NRM)
- To assess incidence of infections
Exploratory objectives
- To assess the cumulative steroid dose until Day 56 and Day 90
- To assess Event-Free Survival (EFS)
- To assess incidence of Malignancy Relapse/Progression
- To measure the incidence of chronic GvHD
- To measure immune reconstitution
- To evaluate changes in Patient Reported Outcomes
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A randomized (1:1) phase II open label study of DSC compared to Investigator choice Best Available Therapy (BAT) in allogeneic hematopoietic stem cell transplant recipients with Grades II-IV steroid refractory acute graft vs. host disease. Patients will receive 2 doses of DSC. Additional doses (up to 4 doses) may be given depending on response. No cross-over are planned in the second stage of the study.
| Arm | Type | Receives |
|---|---|---|
| Decidua Stroma Cells (DSC) | Experimental | Biological: Decidua Stroma Cells (DSC)Placenta derived decidua stroma cells (DSC). In the first phase I part, two different dose levels will be used, 1x10^6/kg and 3x10^6/kg. Two doses, one week apart, will be given. The decision to proceed to the next dose level will depend on results observed at the previous dose level. The dose in the randomized part will be based on the findings in the phase I part. In the Phase II study all patients will receive 2 doses, one week apart. Depending on response, up to 6 doses in total may be given. Additional doses (beyond the first 2 doses) may be given one week apart until response. |
| Best Available Treatment (BAT) | Active comparator | Drug: Best available Treatment (BAT)The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: anti-thymocyte globulin (ATG), extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult patients (age ≥ 18 years) with steroid refractory acute GvHD grades II-IV after allo-HSCT.
- Signed written study informed consent once SR-aGvHD is confirmed.
Key exclusion criteria (16 listed)
- Presence of an active uncontrolled infection including significant bacterial, fungal, viral or parasitic infection requiring treatment.
- Has received systemic treatment for aGvHD apart from steroids.
- Clinical presentation resembling de novo chronic GvHD or GvHD overlap syndrome.
- Pregnant or lactating women.
- Significant respiratory disease.
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 |
|---|---|---|
| Decidua Stroma Cells (DSC)Placenta-derived Decidua Stroma Cells. The product consists of a viable allogeneic DSCs frozen in 5% of human serum albumin (HSA) in sodium chloride (NaCl) 0.9% and 10% dimethylsulfoxide (DMSO), that is thawed and immediately diluted in 40 mL sodium chloride (NaCl) 0.9% prior to infusion. That will give a final concentration of 2.2% HSA and 2% DMSO. DSC will be infused when steroid-refractory acute GVHD after allogenic stem-cell transplantation has been diagnosed. Two doses, one week apart, will be given to all patients. Additional doses will be used depending on response. | Biological | Decidua Stroma Cells (DSC) |
| Best available Treatment (BAT)Also: ECP, Everolimus, Sirolimus, Etanercept, Vedolizumab, Ruxolitinib, Infliximab.The BAT in this study will freely be identified by the Investigator prior to patient randomization and may include treatments such as: extracorporeal photopheresis (ECP), low-dose methotrexate (MTX), mycophenolate mofetil (MMF), mTOR inhibitors (everolimus or sirolimus), etanercept, vedolizumab, ruxolitinib or infliximab. Dose and frequency will depend on label (where approved) and institutional guidelines for various BAT. | Drug | Best Available Treatment (BAT) |
Primary outcome
Safety and tolerability evaluation including Severe Adverse Events (SAE).
Time frame: 5 years
Adverse events will be assessed and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03.
Durable Response to treatment
Time frame: 56 days
Durable Overall Response (DOR) day 56.
8 secondary outcomes
Number of patients with overall response (CR+PR) at day 28
Time frame: 28 days
Rate of Survival
Time frame: 1 year
Incidence of Non-Relapse Mortality (NRM)
Time frame: 1 year
Incidence of infections
Time frame: 1 year
Change of Quality of Life
Time frame: 1 year
Incidence of Relapse
Time frame: 5 year
Incidence of secondary malignancies
Time frame: 5 year
Incidence of chronic GVHD
Time frame: 5 year
Results and safety
The study was stopped early (reason given: Too slow recruitment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2026.
- Results publication: PubMed 29533533Ringden O, Baygan A, Remberger M, Gustafsson B, Winiarski J, Khoein B, Moll G, Klingspor L, Westgren M, Sadeghi B. Placenta-Derived Decidua Stromal Cells for Treatment of Severe Acute Graft-Versus-Host Disease. Stem Cells Transl Med. 2018 Apr;7(4):325-331. doi: 10.1002/sctm.17-0167. Epub 2018 Mar 13.
- Results publication: PubMed 31173898Sadeghi B, Remberger M, Gustafsson B, Winiarski J, Moretti G, Khoein B, Klingspor L, Westgren M, Mattsson J, Ringden O. Long-Term Follow-Up of a Pilot Study Using Placenta-Derived Decidua Stromal Cells for Severe Acute Graft-versus-Host Disease. Biol Blood Marrow Transplant. 2019 Oct;25(10):1965-1969. doi: 10.1016/j.bbmt.2019.05.034. Epub 2019 Jun 4.
- 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.
Mats Remberger, Professor study director
KFUE, Uppsala University Hospital, Uppsala, Sweden
Ulla Olsson-Strömberg, AssProfessor principal investigator
Dep of Hematology, Uppsala University Hospital, Uppsala, Sweden
4 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Decidua Stroma Cells (DSC) and Best available Treatment (BAT) in people with GVHD, Acute, run by Mats Remberger at 4 sites in 3 countries.
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 2 inclusion and 16 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 6 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden, Denmark, Norway. 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 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?
The study was stopped early (reason given: Too slow recruitment). 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?
Safety and tolerability evaluation including Severe Adverse Events (SAE). (time frame: 5 years). 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 NCT04118556, which also lists 2 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 6 May 2026.