COVID-19Phase 1/2COVIDMESNCT04390139
Efficacy and Safety Evaluation of Mesenchymal Stem Cells for the Treatment of Patients With Respiratory Distress Due to COVID-19
A Phase 1/2 study testing XCEL-UMC-BETA in people with COVID-19 and SARS-CoV 2, run by Banc de Sang i Teixits at 5 sites in Spain.
Trial summary
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- COVID-19, SARS-CoV 2, Adult Respiratory Distress Syndrome
- What is being tested?
- XCEL-UMC-BETA
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 26 participants
- Where
- 5 sitesSpain
- Study dates
- 13 May 2020to 20 Dec 2022
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Positive PCR fpr SARS-CoV-2
- Intensive Care Unit admission for less than 3 days
- Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 ≤ 200 mmHg)
- Male or female, aged 18 to 70 years old
- Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)
Who cannot join
- Expected survival less than 3 days
- Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
- Neoplastic disease either active or without complete remission
- Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
- Pregnant or lactating women
- Participation in another clinical trial with an experimental drug in the last 30 days
- Other pathologies that, in medical judgment, contraindicate participation in the study
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital del Mar
Barcelona, 08003
Hospital Vall d'Hebron
Barcelona, 08035
Hospital Clínic de Barcelona
Barcelona, 08036
Hospital de Bellvitge
L'Hospitalet de Llobregat, Barcelona, 08907
Mútua de Terrassa
Terrassa, Barcelona, 08221
About this study
Official title: A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
Read the detailed description
This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.
The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.
Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
- Conditions
- COVID-19, SARS-CoV 2, Adult Respiratory Distress Syndrome
- Being tested
- XCEL-UMC-BETA, Placebo
- Keywords
- ARDS
- Medical subject headings
- COVID-19, Respiratory Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
XCEL-UMC-BETADrug
Also called WJ-MSC
Administration on top of the standard administered treatment
PlaceboOther
Administration on top of the standard administered treatment
| Study group | Role | What they receive |
|---|---|---|
| Treatment A | Experimental | Wharton-Jelly mesenchymal stromal cells on D1 and D3 Receives: Drug: XCEL-UMC-BETA |
| Treatment B | Placebo comparator | Placebo on D1 and D3 Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
All-cause mortality at day 28
Number of patients who died, by treatment group
Measured: Day 28
Secondary outcomes (15)
Safety of WJ-MSC
Number of patients with treatment-emergent adverse events, by treatment group
Measured: Day 28
Need for treatment with rescue medication
Number of patients who, after the start of treatment, required rescue medication, by treatment group
Measured: Day 28
Need and duration of mechanical ventilation
Number of days that the patient requires invasive mechanical ventilation from the start of treatment to day +28, by treatment group
Measured: Day 28
Ventilator free days
Days after treatment in which the patient remains alive and free of invasive mechanical ventilation, per treatment group.
Measured: Day 28
Evolution of PaO2 / FiO2 ratio
Variation of the oxygenation index (PaO2 / FiO2) with respect to the baseline value, by treatment group.
Measured: Day 28
Evolution of the SOFA index
Variation of the score of the Sequential Organ Failure Assessment (SOFA) Index with respect to the baseline value, by treatment group.
Measured: Day 28
Evolution of the APACHE II score
Variation of Acute Physiology and Chronic Health disease Classification System II (APACHE II) score, by treatment group.
Measured: Day 28
Duration of hospitalization
Days of stay in the ICU from the day of admission until discharge to day 28, or date of death if earlier, by treatment group.
Measured: Day 28
Evolution of markers of immune response (leucocyte count, neutrophils)
Variation in the count and percentage of leukocytes and neutrophils, by treatment group.
Measured: Day 28
Feasibility of WJ-MSC administration
Feasibility will be evaluated by the time elapsed from the request of the treatment by the hospital center until the delivery date
Measured: Day 28
Feasibility of WJ-MSC administration
Feasibility will be evaluated by the number of patients treated within 2 days of the request for treatment.
Measured: Day 28
Evolution of disease biomarker: polymerase chain reaction (RT-PCR)
Variation in the values of the biomarker, by treatment group.
Measured: Day 28
Evolution of disease biomarker: lactate dehydrogenase (LDH)
Variation in the values of the biomarker, by treatment group.
Measured: Day 28
Evolution of disease biomarker: D-dimer
Variation in the values of the biomarker, by treatment group.
Measured: Day 28
Evolution of disease biomarker: Ferritin
Variation in the values of the biomarker, by treatment group.
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 May 2020
- Study start13 May 2020
- Primary completion20 Dec 2022
- Study completion20 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies 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
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoni Torres, MD, PhD, Study chair, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04390139
- Sponsor's protocol ID
- BST-COVID-01
- Acronym
- COVIDMES
- Status last verified
- Jan 2023
- First submitted
- 7 May 2020
- Last updated
- 26 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Double-blind, Randomized, Parallel, Placebo-controlled Pilot Clinical Trial for the Evaluation of the Efficacy and Safety of Two Doses of WJ-MSC in Patients With Acute Respiratory Distress Syndrome Secondary to Infection by COVID-19
- ClinicalTrials.gov ID
- NCT04390139
- Acronym / sponsor ID
- COVIDMES / BST-COVID-01
- Conditions
- COVID-19, SARS-CoV 2, Adult Respiratory Distress Syndrome
- Keywords
- ARDS
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Study start
- 13 May 2020 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Dec 2022 (actual)
- First posted
- 15 May 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.
Randomized, double-blind, parallel, two-arms clinical trial to assess the efficacy and safety of 2 infusions of Wharton-Jelly mesenchymal stromal cells (day 1 and day 3, endovenously at 1E6cells/Kg per dose) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. Follow-up will be established on days 3, 5, 7, 14, 21, and 28. Long term follow-up will be performed at 3, 6 and 12 months.
Detailed description
This is a prospective, double-blind, randomized, parallel, placebo-controlled pilot clinical trial to assess the efficacy and safety of two infusions of Wharton Jelly mesenchymal stromal cells (WJ-MSC) in patients with moderate acute respiratory distress syndrome (ARDS) secondary to SARS-CoV-2 infection. The study will enroll 30 patients who after signing the informed consent will be checked for inclusion and exclusion criteria. Patients will then be randomized (1:1) to one of the 2 treatment arms: Treatment A WJ-MSC/WJ-MSC; Treatment B Placebo/ Placebo. The 2 infusions will be administered endovenously on day 1 (D1) and on D3. Thereafter, patients will be followed-up on days 3, 5, 7, 14, 21, and 28 Once the study is completed, controls will be established at 3 months, 6 months and 12 months as long-term follow-up.
The study treatments (A or B) will be added on top of the Standard of Care treatment prescribed by the attending physician. Each dose of MSC-WJ will consist of the intravenous administration of 1E6cells/Kg.
Recruitment will be competitive for the centers participating in the study. A Data Safety and Monitoring Board (DSMB) will be established to review safety and efficacy along the trial.
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 |
|---|---|---|
| Treatment A | Experimental | Drug: XCEL-UMC-BETAWharton-Jelly mesenchymal stromal cells on D1 and D3 |
| Treatment B | Placebo comparator | Other: PlaceboPlacebo on D1 and D3 |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Positive PCR fpr SARS-CoV-2
- Intensive Care Unit admission for less than 3 days
- Moderate acute respiratory distress (Berlin criteria definition with 100 mmHg < PaO2/FiO2 ≤ 200 mmHg)
- Male or female, aged 18 to 70 years old
- Signed informed consent by the patient or by a legal representative (in this case, can be obtained by phone, although it must be confirmed in writing later, accepted by email)
Key exclusion criteria (7 listed)
- Expected survival less than 3 days
- Treatment with immunosuppressive drugs (tocilizumab, sarilumab) with corticosteroids being allowed
- Neoplastic disease either active or without complete remission
- Immunosuppressed patients (except treatment with corticosteroids for respiratory distress)
- Pregnant or lactating women
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 |
|---|---|---|
| XCEL-UMC-BETAAlso: WJ-MSCAdministration on top of the standard administered treatment | Drug | Treatment A |
| PlaceboAdministration on top of the standard administered treatment | Other | Treatment B |
Primary outcome
All-cause mortality at day 28
Time frame: Day 28
Number of patients who died, by treatment group
15 secondary outcomes
Safety of WJ-MSC
Time frame: Day 28
Need for treatment with rescue medication
Time frame: Day 28
Need and duration of mechanical ventilation
Time frame: Day 28
Ventilator free days
Time frame: Day 28
Evolution of PaO2 / FiO2 ratio
Time frame: Day 28
Evolution of the SOFA index
Time frame: Day 28
Evolution of the APACHE II score
Time frame: Day 28
Duration of hospitalization
Time frame: Day 28
Evolution of markers of immune response (leucocyte count, neutrophils)
Time frame: Day 28
Feasibility of WJ-MSC administration
Time frame: Day 28
Feasibility of WJ-MSC administration
Time frame: Day 28
Evolution of disease biomarker: polymerase chain reaction (RT-PCR)
Time frame: Day 28
Evolution of disease biomarker: lactate dehydrogenase (LDH)
Time frame: Day 28
Evolution of disease biomarker: D-dimer
Time frame: Day 28
Evolution of disease biomarker: Ferritin
Time frame: Day 28
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 26 Jan 2023.
- Blood and Tissue Bank of CataloniaLink provided by the sponsor.
- Hospital Clínic de BarcelonaLink provided by the sponsor.
- Hospital Vall d'HebronLink provided by the sponsor.
- Hospital del MarLink provided by the sponsor.
- Mútua de TerrassaLink provided by the sponsor.
- Hospital de BellvitgeLink 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.
Antoni Torres, MD, PhD study chair
Hospital Clinic of Barcelona
5 sites 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 XCEL-UMC-BETA in people with COVID-19 and SARS-CoV 2, run by Banc de Sang i Teixits at 5 sites 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 5 inclusion and 7 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 26 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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. 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 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?
All-cause mortality at day 28 (time frame: Day 28). 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 26 Jan 2023.