COVIDPhase 2NCT04348461
BAttLe Against COVID-19 Using MesenchYmal Stromal Cells
A Phase 2 study testing Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells in people with COVID and Respiratory Distress Syndrome, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
Trial summary
The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously. The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID, Respiratory Distress Syndrome
- What is being tested?
- Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 6 May 2020to 30 Sep 2021
- 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
- Patients of both sexes.
- Over 18 years.
- Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
- Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
- Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
- Women of childbearing potential should have a negative urine pregnancy test performed at the time of study enrollment.
- Written or verbal informed consent from the patient, family member or legal representative.
Who cannot join
- Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
- RT-PCR of SARS-Cov-2 negative.
- Multi-organ failure (more than three organs)
- Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
- Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
- Active tumor disease.
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- Previous immunosuppressive treatment.
- Allergy or hypersensitivity to the administered products.
- History of deep vein thrombosis or pulmonary embolism in the last 3 years.
- Participation in other clinical trials during the 3 months prior to the initial visit.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19
The investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously.
The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.
- Conditions
- COVID, Respiratory Distress Syndrome
- Being tested
- Allogeneic and expanded adipose tissue-derived mesenchymal stromal 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.
Allogeneic and expanded adipose tissue-derived mesenchymal stromal cellsDrug
Two serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Patients receiving regular respiratory distress treatment |
| Treatment | Experimental | Patients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells Receives: Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
Measured: 28 days
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2020
- Study start6 May 2020
- Primary completion15 Sep 2020
- Study completion30 Sep 2021 (estimated)
Why it stopped: lack of financial support
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVIDStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria y Biomédica de Alicante, Hospital General Universitario Gregorio Marañon, Clinica Universidad de Navarra, Universidad de Navarra, University of Salamanca, Hospital General Universitario de Alicante, Hospital Universitario Virgen de la Arrixaca
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04348461
- Sponsor's protocol ID
- BALMYS-19
- Status last verified
- May 2020
- First submitted
- 10 Apr 2020
- Last updated
- 17 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Two-treatment,Randomized, Controlled, Multicenter Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Expanded Allogeneic Adipose Tissue Adult Mesenchymal Stromal Cells in Critically Ill Patients COVID-19
- ClinicalTrials.gov ID
- NCT04348461
- Acronym / sponsor ID
- BALMYS-19
- Conditions
- COVID, Respiratory Distress Syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: lack of financial support
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Instituto de Investigación Sanitaria de la Fundación Jiménez DíazUniversity, hospital or other
- Collaborators
- Instituto de Investigación Sanitaria y Biomédica de Alicante, Hospital General Universitario Gregorio Marañon, Clinica Universidad de Navarra, Universidad de Navarra, University of Salamanca, Hospital General Universitario de Alicante, Hospital Universitario Virgen de la Arrixaca
- Study start
- 6 May 2020 (actual)
- Primary completion
- 15 Sep 2020 (actual)
- Study completion
- 30 Sep 2021 (estimated)
- First posted
- 16 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 investigational medicinal product consists of expanded allogeneic mesenchymal stromal cells derived from adipose tissue and administered intravenously.
The objective of this project is to evaluate the safety and efficacy of the administration of expanded allogeneic adipose tissue adult mesenchymal stem cells, in patients infected with SARS-COV-2 with COVID-19 type complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | –Patients receiving regular respiratory distress treatment |
| Treatment | Experimental | Drug: Allogeneic and expanded adipose tissue-derived mesenchymal stromal cellsPatients receiving two serial doses of allogeneic and expanded adipose tissue-derived mesenchymal stromal cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patients of both sexes.
- Over 18 years.
- Confirmation of SARS-COV-2 infection by RT-PCR in respiratory sample.
- Respiratory failure requiring intubation and connection to mechanical ventilation, secondary to SARS-CoV-2 infection.
- Criteria for acute respiratory distress: acute bilateral alveolar-interstitial infiltrate not compatible with left ventricular failure (demonstrated with ultrasound or hemodynamic parameters), sudden onset, and blood gas compromise with a PaO2 / FiO2 ratio <200 mm-Hg.
Key exclusion criteria (10 listed)
- Any other cause of acute respiratory distress not attributable to SARS-Cov-2.
- RT-PCR of SARS-Cov-2 negative.
- Multi-organ failure (more than three organs)
- Severe respiratory failure requiring extracorporeal support (ECMO) Grave Moderate severe COPD requiring chronic home oxygen therapy, need for prior home oxygen therapy for any reason.
- Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures.
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 |
|---|---|---|
| Allogeneic and expanded adipose tissue-derived mesenchymal stromal cellsTwo serial doses of 1.5 million adipose-tissue derived mesenchymal stem cells per kg | Drug | Treatment |
Primary outcome
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate)
Time frame: 28 days
Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Mar 2021.
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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 2 study testing Allogeneic and expanded adipose tissue-derived mesenchymal stromal cells in people with COVID and Respiratory Distress Syndrome, run by Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz at 1 site in Spain.
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 7 inclusion and 10 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: paused, as of the sponsor's last update on 17 Mar 2021. 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 Spain. 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?
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?
Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate) (time frame: 28 days). 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?
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 17 Mar 2021; AzTrials last refreshed its copy on 3 Nov 2026.