Covid19Phase 1NCT04611256
Mesenchymal Stem Cells in Patients Diagnosed With COVID-19
A Phase 1 study testing MSC in people with Covid19, run by Hospital Reg. Lic. Adolfo Lopez Mateos at 1 site in Mexico.
Trial summary
The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19
- What is being tested?
- MSC
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteMexico
- Study dates
- 1 Aug 2020to 30 Dec 2020
- 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
- Aged between 18 and 65.
- RT-PCR positive for SARS-CoV-2 (Berlin protocol).
- Moderate to severe acute respiratory insufficiency (100 mmHg <PaO2/FiO2 ≤ 200 mmHg).
- Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
- Being under standard therapy for COVID-19.
- Informed consent signed by the patient or a legally acceptable representative (in the case of the legal representative, informed consent could be obtained by a phone call or email with the subsequent written confirmation).
Who cannot join
- Reserved prognosis (survival expected by the physician of fewer than three days).
- Being under immunosuppressive drug treatment.
- Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
- Immunosuppressed patients (except when the cause is corticosteroid treatment).
- Pregnant or lactating women.
- Patients who plan to become pregnant during the study period or within six months after the end of the study period.
- Participation in another clinical trial with an experimental drug during the last 30 days.
- Pathologies that in medical judgment constitute a contraindication to participate in the study.
Trial locations and contacts
1 site in 1 country.
Mexico1 site, 1 recruiting
- Recruiting
Hospital Regional Lic Adolfo Lopez Mateos
Mexico City, Ciudad de Mexico CDMX (Mexico City), 01030
Martha E. Rodríguez Arellano, MD, +52 5512999131, marthaeunicer@yahoo.com.mx
About this study
Official title: Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition
The propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.
Read the detailed description
Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues.
Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each.
We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25.
Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.
- Conditions
- Covid19
- Being tested
- MSC, Control
- Keywords
- COVID-19, Adjuvant therapy, mesenchymal stem cells, Mexico
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MSCBiological
Two intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach
ControlDrug
Conventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant.
| Study group | Role | What they receive |
|---|---|---|
| MSC transfusion | Experimental | Not described Receives: Biological: MSC |
| Control | Active comparator | Not described Receives: Drug: Control |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change form baseline in Arterial oxygen saturation
Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography
Measured: up to 25 days
Change form baseline in Arterial oxygen saturation
Aretrial oxygen saturation will be taken by an oximeter
Measured: up to 25 days
Days to clinical improvement
Number of days of patient discharge
Measured: up to 25 days
Secondary outcomes (4)
Change Form Baseline in C reactive protein at 25 days
Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Measured: up to 25 days
Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes
Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Measured: up to 25 days
Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10
Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Measured: up to 25 days
Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.
Blood samples will be taken on days 1, 3, 7, 15, 20, 25
Measured: up to 25 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2020
- Study start1 Aug 2020
- Primary completion30 Nov 2020 (estimated)
- Study completion30 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies 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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Reg. Lic. Adolfo Lopez Mateos
- Sponsor type
- Other government
- Collaborators
- Instituto de Terapia Celular: ITC
- Responsible party
- Principal investigator, M. Eunice Rodríguez Arellano, Hospital Reg. Lic. Adolfo Lopez Mateos
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04611256
- Sponsor's protocol ID
- 060I.2020
- Status last verified
- Nov 2020
- First submitted
- 29 Oct 2020
- Last updated
- 12 Nov 2020
- 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 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adjuvant Therapy With Mesenchymal Stem Cells in Patients Diagnosed With COVID-19 in Critical Condition
- ClinicalTrials.gov ID
- NCT04611256
- Acronym / sponsor ID
- 060I.2020
- Conditions
- Covid19
- Keywords
- COVID-19, Adjuvant therapy, mesenchymal stem cells, Mexico
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Hospital Reg. Lic. Adolfo Lopez MateosOther government
- Collaborators
- Instituto de Terapia Celular: ITC
- Study start
- 1 Aug 2020 (actual)
- Primary completion
- 30 Nov 2020 (estimated)
- Study completion
- 30 Dec 2020 (estimated)
- First posted
- 2 Nov 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 propose of this study is implement adjuvant therapy with adipose tissue derived-mesenchymal stem cells (MSCs) for critical COVID-19 patients admitted to the intensive care unit of the Regional Hospital Lic. Adolfo López Mateos of the Institute for Social Security and Services for State Workers to reduce cytokine storm and contribute to the favorable resolution of respiratory insufficiency and multiple organic failure.
Detailed description
Within the epidemic context of phase 3 that currently exists in Mexico, implementation of new treatments that have shown to be beneficial for patients in a critical state in other countries is an urgent need. Adipose tissue derived-mesenchymal stem cells for could favor the regulation of patient immune system to reduce the proinflammatory state and promoting the regeneration of damaged tissues.
Patients diagnosed COVID-19 and confirmed positive with the virus by PCR, will be treated with two intravenous infusions MSCs on the day 1 (D1) and the day 3 (D3) of the treatment consisting of 1X106/kg each.
We will assess the pulmonary lesion area by chest x-ray or computed axial tomography at baseline and days 2, 3, 5, 10, 15, 20, and 25.
Days to clinical improvement (to be evaluated on days 2, 3, 5, 10, 15, 20, 25), considering temperature and other vital signs measurement, arterial oxygen saturation, blood chemistry (including liver function tests), creatine phosphokinase, C reactive protein, immune cells (CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes), pro-inflammatory cytokines (IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10), immunoglobulins (IgA, IgG, IgM, and IgE), HLA profile expression, and weaning from mechanical ventilation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MSC transfusion | Experimental | Biological: MSC |
| Control | Active comparator | Drug: Control |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Aged between 18 and 65.
- RT-PCR positive for SARS-CoV-2 (Berlin protocol).
- Moderate to severe acute respiratory insufficiency (100 mmHg <PaO2/FiO2 ≤ 200 mmHg).
- Confirmatory diagnosis of pulmonary injury by chest teleradiography or computed axial t tomography.
- Being under standard therapy for COVID-19.
Key exclusion criteria (8 listed)
- Reserved prognosis (survival expected by the physician of fewer than three days).
- Being under immunosuppressive drug treatment.
- Severe kidney failure (estimated glomerular filtration rate < 30 ml/min) or under continuous kidney replacement therapy, hemodialysis, or peritoneal dialysis.
- Immunosuppressed patients (except when the cause is corticosteroid treatment).
- 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 |
|---|---|---|
| MSCTwo intravenous infusion of 1*10E6 adipose tissue derived-MSCs /kg body weight reach | Biological | MSC transfusion |
| ControlConventional treatment that may include analgesic, anti-inflammatory, antibiotic, steroid, antiplatelet, and anticoagulant. | Drug | Control |
Primary outcome
Change form baseline in Arterial oxygen saturation
Time frame: up to 25 days
Pulmonary lesion area will be taken by a chest x-ray or computed axial tomography
Change form baseline in Arterial oxygen saturation
Time frame: up to 25 days
Aretrial oxygen saturation will be taken by an oximeter
Days to clinical improvement
Time frame: up to 25 days
Number of days of patient discharge
4 secondary outcomes
Change Form Baseline in C reactive protein at 25 days
Time frame: up to 25 days
Change Form Baseline Immune cells: CD3+, CD4+, CD8+, CD16+, CD19+, and CD56+ lymphocytes
Time frame: up to 25 days
Change Form Baseline in pro-inflammatory cytokines: IL-1β, IL- 2, TNF-α, ITN-γ, IL-4, IL-6, IL-10
Time frame: up to 25 days
Change Form Baseline in Immunoglobulins; IgA, IgG, IgM, and IgE.
Time frame: up to 25 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- 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.
Hospital Regional Lic Adolfo Lopez Mateos
Mexico City, Mexico
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 MSC in people with Covid19, run by Hospital Reg. Lic. Adolfo Lopez Mateos at 1 site in Mexico.
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 8 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: status not confirmed, as of the sponsor's last update on 12 Nov 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 Mexico. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change form baseline in Arterial oxygen saturation (time frame: up to 25 days). The study lists 3 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 12 Nov 2020.