Respiratory Tract DiseasesPhase 1/2ASC COVID-19NCT04341610
ASC Therapy for Patients With Severe Respiratory COVID-19
A Phase 1/2 study testing Stem Cell Product in people with Respiratory Tract Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
Trial summary
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Respiratory Tract Diseases
- What is being tested?
- Stem Cell Product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteDenmark
- Study dates
- 20 Apr 2020to 30 Apr 2021
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients between 18-80 years
- Confirmed HCoV-19 infection
- Temperature above 38.0o C
- Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:
- Respiratory distress, RR ≥ 30/min;
- Oxygen saturation ≤ 93% at rest state;
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- Arterial partial pressure of oxygen (PaO2) / Fraction of inspiration O2 (FiO2) ≤ 300mmHg, 1mmHg=0.133kPa
- Pneumonia that is judged by chest radiograph or computed tomography
- In respirator and possible for treatment within the first 24 hours
Who cannot join
- Patients that have need for additional immunosuppressive treatment
- Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
- Co-Infection with other infectious agent.
- Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
- Patients who are participating in other clinical trials.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
2014 Department of Cardiology, The Heart Centre, University Hospital Rigshospitalet
Copenhagen, 2100
About this study
Official title: Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system.
This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death.
Read more
We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function.
The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
- Conditions
- Respiratory Tract Diseases
- Being tested
- Stem Cell Product
- Medical subject headings
- Respiratory Tract Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stem Cell ProductDrug
100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline
| Study group | Role | What they receive |
|---|---|---|
| ASC | Active comparator | 100 million allogeneic adipose-derived mesenchymal stromal cell Receives: Drug: Stem Cell Product |
| Placebo | Placebo comparator | Saline Receives: Drug: Stem Cell Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in clinical critical treatment index
Measured: day 7 from randomization
Secondary outcomes (8)
Days of respirator treatment
Measured: 3 months
Improvement of clinical symptoms including duration of fever and respiratory need
Measured: 3 months
Mortality
Measured: 3 months
Marker of Immunological function -CD4+ and CD8+ T cell count
Measured: 3 months
C-reactive protein and leucocyte
Measured: 3 months
Cytokine profile
Measured: 3 months
Glomerular Filtration Rate
Measured: 3 months
Duration of hospitalization
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2020
- Study start20 Apr 2020 (estimated)
- Primary completion30 Jan 2021 (estimated)
- Study completion30 Apr 2021 (estimated)
Why it stopped: Not approved by ethical committee
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory Tract DiseasesStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Double-blind placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, JKastrup, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04341610
- Sponsor's protocol ID
- EudraCT number: 2020-001330-36
- Acronym
- ASC COVID-19
- Status last verified
- May 2020
- First submitted
- 7 Apr 2020
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Adipose Tissue Derived Mesenchymal Stromal Cell Therapy for Treating Patients With Severe Respiratory COVID-19. A Danish, Double-blind, Randomized Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT04341610
- Acronym / sponsor ID
- ASC COVID-19 / EudraCT number: 2020-001330-36
- Conditions
- Respiratory Tract Diseases
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Not approved by ethical committee
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Study start
- 20 Apr 2020 (estimated)
- Primary completion
- 30 Jan 2021 (estimated)
- Study completion
- 30 Apr 2021 (estimated)
- First posted
- 10 Apr 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.
The emerging field of stem cell therapy holds promise of treating a variety of diseases. Especially the mesenchymal stromal cells from bone marrow or adipose tissue (ASCs) have proven their potential for regenerative therapy in patients with ischemic heart disease. Both of these cell types have putative immunomodulatory properties, as they have demonstrated their ability to evade recognition and actively suppress the immune system.
This knowledge is transferred into studies with COVID-19 patients having severe pulmonary dysfunction, to modify the virus induced immunological and inflammatory activity involved in the progression of disease often leading to prolonged ICU stay and in some occasion's death.
We will conduct a clinical trial in which patients with COVID-19 and severe pulmonary symptoms will be randomized to either placebo or treatment with allogeneic CSCC_ASCs from adipose tissue. The aim is to assess the impact of CSCC_ASCs on the activated immune system and clinical efficacy on pulmonary function.
The perspective is that this new information can be of pivotal importance and potentially be a paradigm shift for the clinical problems and severe outcome seen in some patients with severe COVID-19 and other severe diseases with Acute Respiratory Distress Syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Double-blind placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| ASC | Active comparator | Drug: Stem Cell Product100 million allogeneic adipose-derived mesenchymal stromal cell |
| Placebo | Placebo comparator | Drug: Stem Cell ProductSaline |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Patients between 18-80 years
- Confirmed HCoV-19 infection
- Temperature above 38.0o C
- Pulmonary symptoms and signs, at least one of the following before clinical decision for intubation and respirator treatment:
- Pneumonia that is judged by chest radiograph or computed tomography
Key exclusion criteria (5 listed)
- Patients that have need for additional immunosuppressive treatment
- Patients with any past (within the past 3-5 years) or present malignancy (other than excised basal cell carcinoma).
- Co-Infection with other infectious agent.
- Females capable of becoming pregnant must have a negative pregnancy test prior to treatment. After inclusion, they must use contraceptives for 2 months following the given stem cell treatment. The pill, spiral, depot injection of progesterone, sub-dermal implantation, hormonal vaginal ring and transdermal patch regarded as safe contraceptives.
- Patients who are participating in other clinical trials.
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 |
|---|---|---|
| Stem Cell Product100 million allogeneic adipose-derived mesenchymal stromal cells diluted in 100 ml saline | Drug | ASC, Placebo |
Primary outcome
Changes in clinical critical treatment index
Time frame: day 7 from randomization
8 secondary outcomes
Days of respirator treatment
Time frame: 3 months
Improvement of clinical symptoms including duration of fever and respiratory need
Time frame: 3 months
Mortality
Time frame: 3 months
Marker of Immunological function -CD4+ and CD8+ T cell count
Time frame: 3 months
C-reactive protein and leucocyte
Time frame: 3 months
Cytokine profile
Time frame: 3 months
Glomerular Filtration Rate
Time frame: 3 months
Duration of hospitalization
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Stem Cell Product in people with Respiratory Tract Diseases, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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 9 inclusion and 5 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: withdrawn, as of the sponsor's last update on 27 May 2020. 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 Denmark. 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Changes in clinical critical treatment index (time frame: day 7 from randomization). 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 27 May 2020.