Clinical trial of administration of MSC to patients with respiratory distress type COVID-19

Two-center, randomized, controlled clinical trial with two treatment arms to evaluate the safety and efficacy of intravenous administration of expanded allogeneic adipose tissue adult mesenchymal cells in critically ill patients COVID-19.

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001266-11-ES

Enrollment

100

Registered

2020-04-16

Start date

2020-04-16

Completion date

Unknown

Last updated

2021-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory distress secondary to SARS-Cov-2 infection

Interventions

Product Name: Allogeneic mesenchymal stromal cells isolated from adipose tissue Pharmaceutical Form: Solution for injection INN or Proposed INN: Allogeneic adipose-derived mesenchymal stromal cells in

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: -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 =65 years) yes F.1.3.1 Number of subjects for this age range 100

Exclusion criteria

Exclusion criteria: -Any other cause of acute respiratory distress not attributable to SARS-Cov-2. -RT-PCR of SARS-Cov-2 negative. Mult Multi-organ failure (more than three organs) -Severe respiratory failure requiring extracorporeal support (ECMO) -Moderate- severe COPD requiring chronic home oxygen therapy. -Pregnancy, lactation and women of childbearing age but who do not take effective contraceptive measures. -Active tumor disease. -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.

Design outcomes

Primary

Measure	Time frame
Main Objective: The main objective of this project is to evaluate the efficacy of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19.;Secondary Objective: -To evaluate the safety of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19. -To evaluate preclincial variables;Primary end point(s): ?% survival at 28 days after treatment ? Days from the patient enters the study until the temperature normalizes: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. o Normalization of the temperature defined as: reaching a body temperature between 35ºC and 37ºC ? Days until patient was extuted: defined as (Total days with mechanical ventilation) - (Total days without mechanical ventilation) Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Number of patients who abandoned mechanical ventilation, defined as: (Total of patients with mechanical ventilation at the time of inclusion) - (Total of patients who abandoned mechanical ventilation) Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Number of patients that go from Mechanical Ventilation to oxygen therapy: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Duration of oxygen therapy (days), defined as: (Total days in the study) - (Total days of need for oxygen therapy). Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Days of stay in the Intensive Care Unit: defined as (Total days in the study) - (Total days in the Intensive Care Unit). ? Duration of hospitalization (days): defined as (Total days in the study) - (Total days hospitalized) ? Oxygen saturation: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month Pa PaO2 / FiO2 ratio: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month, and 6th month. Radi Radiological pattern on Che	—

Measure

Time frame

Main Objective: The main objective of this project is to evaluate the efficacy of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19.;Secondary Objective: -To evaluate the safety of the administration of expanded allogeneic adipose tissue mesenchymal stem cells, in patients infected with SARS-COV-2 with complications like COVID-19. -To evaluate preclincial variables;Primary end point(s): ?% survival at 28 days after treatment ? Days from the patient enters the study until the temperature normalizes: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. o Normalization of the temperature defined as: reaching a body temperature between 35ºC and 37ºC ? Days until patient was extuted: defined as (Total days with mechanical ventilation) - (Total days without mechanical ventilation) Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Number of patients who abandoned mechanical ventilation, defined as: (Total of patients with mechanical ventilation at the time of inclusion) - (Total of patients who abandoned mechanical ventilation) Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Number of patients that go from Mechanical Ventilation to oxygen therapy: measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Duration of oxygen therapy (days), defined as: (Total days in the study) - (Total days of need for oxygen therapy). Measured on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month. ? Days of stay in the Intensive Care Unit: defined as (Total days in the study) - (Total days in the Intensive Care Unit). ? Duration of hospitalization (days): defined as (Total days in the study) - (Total days hospitalized) ? Oxygen saturation: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month and 6th month Pa PaO2 / FiO2 ratio: measurement on Day 1, Day 3, Day 7, Day 10, 3rd month, and 6th month. Radi Radiological pattern on Che

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Secondary

Measure	Time frame
Secondary end point(s): Preclinical variables ? Immune functions o T lymphocyte count o Count of CD4 + T lymphocytes, CD8 + T lymphocytes and B lymphocytes (flow cytometry) o Alanine aminotransferase ? Analytics o Blood concentration of IL-1ß, IL-2R, IL-4 IL-6, IL-8, IL-10, TNF-a, IFN?, TGFß o Pro-Peptide B natriuretic (pro-BNP) Safety variables ?% and type of complications derived from treatment. o Complications during the application of the treatment (Day 1) o Complications on Day 3, Day 7, Day 10, Day 28, 3rd month and 6th month.;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 7, Day 10, Third Month, Sixth Month	—

Measure

Time frame

Secondary end point(s): Preclinical variables ? Immune functions o T lymphocyte count o Count of CD4 + T lymphocytes, CD8 + T lymphocytes and B lymphocytes (flow cytometry) o Alanine aminotransferase ? Analytics o Blood concentration of IL-1ß, IL-2R, IL-4 IL-6, IL-8, IL-10, TNF-a, IFN?, TGFß o Pro-Peptide B natriuretic (pro-BNP) Safety variables ?% and type of complications derived from treatment. o Complications during the application of the treatment (Day 1) o Complications on Day 3, Day 7, Day 10, Day 28, 3rd month and 6th month.;Timepoint(s) of evaluation of this end point: Day 1, Day 3, Day 7, Day 10, Third Month, Sixth Month

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Countries

Spain

Contacts

Public ContactUnidad de Investigación Clínica

Fundación Instituto de Investigación Sanitaria Fundación Jiménez Díaz

mireia.arcas@fjd.es0034915 50 48 003214

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026