ARDS, HumanPhase 1ARDS-MSC-205NCT04447833
Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome
A Phase 1 study testing Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 in people with ARDS, Human and COVID, run by Uppsala University at 1 site in Sweden.
Trial summary
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- ARDS, Human, COVID
- What is being tested?
- Mesenchymal Stromal Stem Cells - KI-MSC-PL-205
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteSweden
- Study dates
- 17 Jun 2020to 15 Apr 2026
- 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)
- Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening
- Male or female patient aged 18 to 65 years old
- Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
- Patient is on respirator support within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
- Pregnancy test in blood confirming negative results before enrolment (for women ≤55 years old)
Who cannot join
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded
- Pregnant or breast feeding female
- Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery
- Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications)
- Patients with a history during the latest five years and/or on-going treatment for systemic infection (e.g. Septicaemia due to in vivo foreign body (e.g. stents, catheters, heart valve), tuberculosis, malaria, other opportunistic and parasite infections)
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- Prisoner
- Any other irreversible disease or condition for which six-month mortality is estimated to be greater than 50%
- Moderate to severe liver failure (Child-Pugh Score >12)
- Reduced renal function with a creatinine clearance (Cockcroft-Gault Equation) < 45 mL/min/1.73m2
- Severe chronic respiratory disease with a PaCO2 >50 mmHg or the use of home oxygen
- Major trauma in the prior 5 days
- Lung transplant patient
- Patients on ECMO-support
- Patients with a previous history of severe burns
- Documented deep venous thrombosis or pulmonary embolism within past three months
- Known hypersensitivity to DMSO
- Investigator considers the patient unlikely to comply with study procedures, restrictions and requirements
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome Validation of Mechanistic Pathways and Clinical Efficacy
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
- Conditions
- ARDS, Human, COVID
- Being tested
- Mesenchymal Stromal Stem Cells - KI-MSC-PL-205
- Keywords
- Mesenchymal Stromal Stem Cells
- Medical subject headings
- Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mesenchymal Stromal Stem Cells - KI-MSC-PL-205Drug
Also called Allogeneic Bone Marrow Derived Mesenchymal Stem Cells
Allogeneic bone marrow derived mesenchymal stromal stem cells (MSCs).
| Study group | Role | What they receive |
|---|---|---|
| Mesenchymal Stromal Stem Cell Treatment | Experimental | Infusion of allogeneic bone marrow derived mesenchymal stromal stem cells (MSC). First three patients receive a singe dose of 1x10^6 MSC/kg dose, next six patients receive a single dose of 2x10^6 MSC/kg. Receives: Drug: Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of pre-specified treatment related adverse events of interest (TRAEIs).
The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion:
- New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion
- New cardiac arrhythmia requiring cardioversion within 10 days after infusion
- Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion
- Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion
- Cardiac arrest or death within 10 days after infusion
Measured: From drug administration to day 10 post-infusion
Secondary outcomes (24)
Safety; All-cause mortality
All-cause mortality at 60 days and then annually
Measured: 60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Leucocytes
Changes from baseline (Day 1; prior to administration of ATIMP) in the leucocyte Count (number/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Trombocytes
Changes from baseline (Day 1; prior to administration of ATIMP) in the trombocyte Count (number/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of C-reactive protein (CRP)
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of CRP (mg/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Prothrombin complex (PK)
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of PK (INR)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Creatinine
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of creatinine (μmol/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Aspartate amino transferase (ASAT)
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ASAT (μkat/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Alanine amino transferase (ALAT)
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of ALAT (μkat/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP)
Changes from baseline (Day 1; prior to administration of ATIMP) in the plasma concentration of NT-proBNP (ng/L)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Blood pressure
Changes from baseline (Day 1; prior to administration of ATIMP) in blood pressure (mmHg)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Body temperature
Changes from baseline (Day 1; prior to administration of ATIMP) in body temperature (°C)
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Efficacy; Changes in pulmonary compliance
Changes from baseline (Day 1; prior to administration of ATIMP) in pulmonary compliance (dynamic and static) until day 10 post-infusion
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Changes in driving pressure (Plateau pressure- PEEP)
Changes from baseline (Day 1; prior to administration of ATIMP) in driving pressure (Plateau pressure- PEEP) until day 10 post-infusion
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Changes in oxygenation (PaO2/FiO2)
Changes from baseline (Day 1; prior to administration of ATIMP) in oxygenation (PaO2/FiO2) until day 10 post-infusion
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Duration of ventilator support
Number of days with ventilator support
Measured: Baseline (pre-infusion),day 1, 2, 3, 4, 7, 10 and 60 post-infusion
Efficacy; Pulmonary bilateral infiltrates
Changes in amount of pulmonary bilateral infiltrates assessed by pulmonary X-ray from baseline (Day 1; prior to administration of ATIMP) until day 60
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Efficacy; Sequential Organ Failure Assessment (SOFA) score
Changes in Sequential Organ Failure Assessment (SOFA) score from baseline (Day 1; prior to administration of ATIMP) and during the ICU-period
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, end of ICU
Efficacy; Hospital stay
Duration of ICU stay and hospital stay (number of days; whole hospital period + calculated from Day 1)
Measured: Day 60 post-infusion
Lung function
Recovery of lung function assessed by Spirometry (FEV1, Vital Capacity) at day 60 and then annually
Measured: Day 60 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Lung fibrosis
To assess development of lung fibrosis using the HRCT Fibrosis Score using Computed tomography (CT) at baseline and on day 1, 3, 7, 10, end of ICU-residence, end of hospital stay, day 60, 6 month and 12 month and end of study (if possible during the infectious stage depending on hospital safety regimen during the pandemic).
Measured: Baseline (pre-infusion), day 1, 3, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Six minutes walk test
Assessment of the patient's physical capacity by 6-Minute-Walk-Test (6MWT), starting at 6 months post Day 1 and then annually
Measured: 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Quality of life
Changes in Quality of Life by assessing the Short Form Health Survey (SF-36) score (starting at 6 months post Day 1 and then annually; patient reported outcome)
Measured: 6 months, 1, 2, 3, 4 and 5 years post-infusion
Blood biomarkers
Change in blood biomarkers related to the proposed mechanisms of action of KI-MSC-PL-205 in ARDS
Measured: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Sensitisation test
Sensitisation tests (test for donor-specific antibodies) against KI-MSC-PL-205 donor
Measured: Baseline (pre-infusion), day 60 post-infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jun 2020
- Study start17 Jun 2020
- Primary completion30 Jan 2021
- Study completion15 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ARDS, HumanStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS).
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Collaborators
- Uppsala University Hospital
- Responsible party
- Sponsor
- Investigators
- Oscar Simonsson, MD, PhD, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04447833
- Sponsor's protocol ID
- 2020-02238
- Acronym
- ARDS-MSC-205
- Status last verified
- Apr 2026
- First submitted
- 20 Jun 2020
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mesenchymal Stromal Cell Therapy For The Treatment Of Acute Respiratory Distress Syndrome Validation of Mechanistic Pathways and Clinical Efficacy
- ClinicalTrials.gov ID
- NCT04447833
- Acronym / sponsor ID
- ARDS-MSC-205 / 2020-02238
- Conditions
- ARDS, Human, COVID
- Keywords
- Mesenchymal Stromal Stem Cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Collaborators
- Uppsala University Hospital
- Study start
- 17 Jun 2020 (actual)
- Primary completion
- 30 Jan 2021 (actual)
- Study completion
- 15 Apr 2026 (actual)
- First posted
- 25 Jun 2020 (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.
This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS), according to the Berlin Definition, and who are on respirator/ventilator (used synonymously in this protocol) support due to respiratory insufficiency with or without concomitant circulatory problems, will be included and treated with a single dose of KI-MSC-PL-205.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is an open label, dose escalating safety study of the advanced therapy investigational medicinal product (ATIMP) KI-MSC-PL-205, where patients diagnosed with SARS-CoV-2-induced severe acute respiratory distress syndrome (ARDS).
| Arm | Type | Receives |
|---|---|---|
| Mesenchymal Stromal Stem Cell Treatment | Experimental | Drug: Mesenchymal Stromal Stem Cells - KI-MSC-PL-205Infusion of allogeneic bone marrow derived mesenchymal stromal stem cells (MSC). First three patients receive a singe dose of 1x10^6 MSC/kg dose, next six patients receive a single dose of 2x10^6 MSC/kg. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Willing and able to provide written informed consent prior to performing study procedures (and have given written consent)
- Coronavirus (SARS-CoV-2) infection confirmed by polymerase chain reaction (PCR) test at screening
- Male or female patient aged 18 to 65 years old
- Patient must fulfil the Berlin Definition of severe ARDS within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
- Patient is on respirator support within 3 weeks to 48 hours prior to enrolment (Will be assessed once the patient has been admitted to the ICU)
Key exclusion criteria (18 listed)
- History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the patient at risk because of participation in the study, or influence the results or the patient's ability to participate in the study
- Patients with history of treated blood and/or solid organ malignancy with recurrence within five years prior to dosing of the ATIMP are to be excluded. Patients with history of cervix cancer and non-melanoma skin cancer with recurrence within two years prior to dosing of the ATIMP are to be excluded
- Pregnant or breast feeding female
- Patient with a history of anti-coagulation therapy for other indications that short-term prophylaxis after surgery
- Patients with a history and/ or on-going treatment for entity associated with bleeding disorder or potential risk for bleeding (e.g. inflammatory bowel disease, gastro-esophagitis with or without ulcers, haemophilia and other bleeding disorders, inflammatory musculo-skeletal disease with potential bleeding complications)
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 |
|---|---|---|
| Mesenchymal Stromal Stem Cells - KI-MSC-PL-205Also: Allogeneic Bone Marrow Derived Mesenchymal Stem CellsAllogeneic bone marrow derived mesenchymal stromal stem cells (MSCs). | Drug | Mesenchymal Stromal Stem Cell Treatment |
Primary outcome
The incidence of pre-specified treatment related adverse events of interest (TRAEIs).
Time frame: From drug administration to day 10 post-infusion
The incidence of pre-specified treatment related adverse events of interest (TRAEIs) occurring during the 10 days interval beginning with the start of the ATIMP infusion: * New ventricular tachycardia, ventricular fibrillation or asystole within 10 days after infusion * New cardiac arrhythmia requiring cardioversion within 10 days after infusion * Clinical scenario consistent with transfusion incompatibility or transfusion-related infection within 10 days after infusion * Thromboembolic events (e.g. Pulmonary embolism) within 10 days after infusion * Cardiac arrest or death within 10 days after infusion
24 secondary outcomes
Safety; All-cause mortality
Time frame: 60 days post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Leucocytes
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Trombocytes
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of C-reactive protein (CRP)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Prothrombin complex (PK)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Creatinine
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Aspartate amino transferase (ASAT)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of Alanine amino transferase (ALAT)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in plasma concentration of N-terminal pro-brain natriuretic peptide (NT-proBNP)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Blood pressure
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Body temperature
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Efficacy; Changes in pulmonary compliance
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Changes in driving pressure (Plateau pressure- PEEP)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Changes in oxygenation (PaO2/FiO2)
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion
Efficacy; Duration of ventilator support
Time frame: Baseline (pre-infusion),day 1, 2, 3, 4, 7, 10 and 60 post-infusion
Efficacy; Pulmonary bilateral infiltrates
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Efficacy; Sequential Organ Failure Assessment (SOFA) score
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, end of ICU
Efficacy; Hospital stay
Time frame: Day 60 post-infusion
Lung function
Time frame: Day 60 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Lung fibrosis
Time frame: Baseline (pre-infusion), day 1, 3, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Six minutes walk test
Time frame: 6 months, 1, 2, 3, 4 and 5 years post-infusion
Changes in Quality of life
Time frame: 6 months, 1, 2, 3, 4 and 5 years post-infusion
Blood biomarkers
Time frame: Baseline (pre-infusion), day 1, 2, 3, 4, 7 and 10 post-infusion, 6 months, 1, 2, 3, 4 and 5 years post-infusion
Sensitisation test
Time frame: Baseline (pre-infusion), day 60 post-infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Apr 2026.
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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.
Oscar Simonsson, MD, PhD principal investigator
Uppsala University
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 Mesenchymal Stromal Stem Cells - KI-MSC-PL-205 in people with ARDS, Human and COVID, run by Uppsala University at 1 site in Sweden.
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 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Apr 2026. 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 Sweden. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
The incidence of pre-specified treatment related adverse events of interest (TRAEIs). (time frame: From drug administration to day 10 post-infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Apr 2026.