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COVID-19 PneumoniaPhase 1/2NCT04461925

Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic P_MMSCs and UC-MMSCs

A Phase 1/2 study testing Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells, Antibiotics and Hormones in people with COVID-19 Pneumonia, run by Institute of Cell Therapy at 1 site in Ukraine.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
COVID-19 Pneumonia
What is being tested?
Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells, Antibiotics and Hormones
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteUkraine
Study dates
2 May 2020to Dec 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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Male or female, aged at 18 years (including) - 75 years old.
  • Laboratory confirmation of SARS-CoV-2 infection by reverse-transcription polymerase chain reaction (RT-PCR) from any diagnostic sampling source.
  • Pneumonia that is judged by X-ray imaging.
  • In accordance with any one of the following:
  • dyspnea (RR ≥ 30 times / min);
  • finger oxygen saturation ≤ 93% in resting state;
  • arterial oxygen partial pressure (PaO2) / oxygen absorption concentration (FiO2) ≤ 300MMHG (if possible);
  • invasive ventilation< 48 h.

Who cannot join

  • Male or female, aged at <18 years and > 75 years old.
  • Pregnancy, lactation and those who are not pregnant but do not take effective contraceptives measures.
  • Patients with malignant tumor, other serious systemic diseases and psychosis.
  • Patients who are participating in other clinical trials.
  • Inability to provide informed consent or to comply with test requirements.
  • Co-Infection of HIV, syphilis.
  • Invasive ventilation > 48 h.
  • Combined with other organ failure (need organ support).

Trial locations and contacts

1 site in 1 country.

Peter Nemtinov, MD contact

+380442079207

nemtinov@stemcellclinic.com

Alina Ustymenko, PhD contact

+380442079207

ustimenko@stemcellclinic.com

Ukraine1 site, 1 recruiting

  • Institute of Cell Therapy

    Kyiv, 04073

    Peter Nemtinov, MD, +380442079207, nemtinov@stemcellclinic.com

    Alina Ustymenko, PhD, +380442079207, ustimenko@stemcellclinic.com

    Recruiting

Other trials in Ukraine

About this study

Official title: Treatment of Coronavirus COVID-19 Pneumonia (Pathogen SARS-CoV-2) With Cryopreserved Allogeneic Multipotent Mesenchymal Stem Cells of the Placenta and Umbilical Cord

Assessment of the clinical effects of infusions of cryopreserved allogeneic multipotent mesenchymal stem cells of the placenta and umbilical cord for COVID-19 patients with acute respiratory distress syndrome.

Read the detailed description

Currently, cell-based therapy and especially stem cell therapy has become a promising therapeutic field, in which many see opportunities to cure incurable diseases. Severe respiratory consequences of the COVID-19, the disease caused by the novel SARS-CoV-2 coronavirus, have prompted urgent need for novel therapies.

Cell-based approaches, primarily using mesenchymal stem cells (MSCs), have demonstrated safety and efficacy in patients with the acute respiratory distress syndrome (ARDS) - common manifestation of cytokine storms, and the cause of death in many COVID-19 patients.

Mesenchymal stem cells are a powerful immunomodulator, they secrete many anti-inflammatory biologically active substances (cytokines) that reduce the inflammatory process in the lungs. Also mesenchymal stem cells secrete numerous growth factors that contribute to the recovery of not only the affected lung tissue but also other organs.

Being tested
Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells, Antibiotics, Hormones, Anticoagulant Therapy, Оxygen therapy
Keywords
Placenta-derived MMSCs, i/v infusions

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal CellsProcedure or surgery

    Also called P-MMSCs

    i/v infusions

  • AntibioticsDrug

    Also called ceftriaxone and azithromycin capsules

    per os

  • HormonesDrug

    Also called dexamethasone

    a moderate amount of dexamethasone i/v

  • Anticoagulant TherapyDrug

    Also called Еnoxaparin

    Sub-Q

  • Оxygen therapyDevice

    Also called Оxygen insufflation

    Оxygen therapy, mechanical ventilation and other supportive therapies

Study groups in NCT04461925
Study groupRoleWhat they receive
Experimental groupExperimentalOn the basis conventional symptomatic treatment and supportive therapy, P-MMSCs were given at 1 million cells/kg body weight/ time, once every 3 days for a total of 3 times: Day "1", Day "4", Day "7".
Receives: Procedure: Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells; Drug: Antibiotics; Drug: Hormones; Drug: Anticoagulant Therapy; Device: Оxygen therapy
Control GroupActive comparatorConventional symptomatic treatments such as antibacterial (ceftriaxone, azithromycin), anticoagulants, hormones, oxygen therapy, mechanical ventilation and other supportive therapies
Receives: Drug: Antibiotics; Drug: Hormones; Drug: Anticoagulant Therapy; Device: Оxygen therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio.

    Improvement of pulmonary function. Arterial oxygen tension PaO2 (in mmHg)/fractional inspired oxygen FiO2 (expressed as a fraction, not a percentage), most conveniently the P/F ratio. The normal P/F ratio is ~ 400-500 mmHg (~55-65 kPa). P/F ratio <300mmHg - sign of Acute Respiratory Distress Syndrome (ARDS)

    Measured: up to 28 days

  2. Changes in length of hospital stay

    Length of Hospital Stay

    Measured: up to 28 days

  3. Changes in mortality rate

    Marker for efficacy of treatment

    Measured: up to 28 days

Secondary outcomes (4)

  1. Changes of С-reactive protein (CRP, mg/L)

    Infection biomarker. Serum CRP levels can be used for early diagnosis of pneumonia, patients with severe pneumonia had high CRP levels.

    Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

  2. Evaluation of Pneumonia Improvement

    CT assessment of pulmonary lesions and lung tissue changes

    Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

  3. Duration of respiratory symptoms (difficulty breathing, dry cough, fever, etc.)

    Indirect response to lung function

    Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

  4. Peripheral blood count recovery time

    Degree of infection

    Measured: At baseline, Day 1, Week 1, Week 2, Week 4, Week 8

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jul 2020
  2. Study start2 May 2020
  3. Primary completion2 May 2021 (estimated)
  4. Study completionDec 2021 (estimated)

Resources

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
Non-randomised
Intervention model
Parallel groups
Model description
Experimental: stem cells therapy + treatment in according with approved by Ukrainian Health Ministry COVID-19 clinical protocol Experimental Group 1: Subjects with severe COVID-19 pneumonia shall be received three infusions of cryopreserved allogeneic P-MMSCs (1 million cells/kg body weight) at 2-days intervals: Day "1", Day "4", Day "7". Control Group: treatment in according with approved by Ukrainian MoH COVID-19 clinical protocol.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04461925
Sponsor's protocol ID
#4/24.04.2020
Status last verified
Jun 2020
First submitted
1 Jul 2020
Last updated
8 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Placenta-Derived MMSCs; Cryopreserved Placenta-Derived Multipotent Mesenchymal Stromal Cells, Antibiotics and Hormones in people with COVID-19 Pneumonia, run by Institute of Cell Therapy at 1 site in Ukraine.

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 8 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 8 Jul 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 Ukraine. 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 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?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Peter Nemtinov, MD (+380442079207, nemtinov@stemcellclinic.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes of oxygenation index PaO2/FiO2, most conveniently the P/F ratio. (time frame: up to 28 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?

On the ClinicalTrials.gov record for NCT04461925.

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 8 Jul 2020.

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