Study with stem cells from allogenic adipose tissue, in patients with coronavirus severe pneumonia

Phase I/II clinical trial to evaluate the safety and efficacy of Allogenic Adipose Tissue-Derived Mesenchymal Stem Cells Expanded in patients with severe COVID-19 pneumonia

Status

Not yet recruiting

Phases

Phase 1Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-001364-29-ES

Enrollment

Registered

2020-04-27

Start date

2020-04-20

Completion date

Unknown

Last updated

2020-05-04

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

Conditions

Severe COVID-19 pneumonia MedDRA version: 23.0 Level: PT Classification code 10051905 Term: Coronavirus infection System Organ Class: 10021881 - Infections and infestations MedDRA version: 20.0 Level: PT Classification code 10070255 Term: Coronavirus test positive System Organ Class: 10022891 - Investigations MedDRA version: 21.1 Level: PT Classification code 10035737 Term: Pneumonia viral System Organ Class: 10021881 - Infections and infestations

Interventions

Product Name: ALLOGENEIC ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS EXPANDED Product Code: CMTAd Pharmaceutical Form: Suspension for injection INN or Proposed INN: EXPANDED HUMAN ALLOGENEIC MESENCH

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age = 18 2. Clinical diagnosis of Pneumonia, severe or critical, caused by COVID-19 infection 3. Life expectancy > 48 hours. 4. Commitment to use a contraceptive method of proven efficacy in both men and women during the duration of the clinical trial. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 26 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 26

Exclusion criteria

Exclusion criteria: 1. Coinfection with other viruses or bacteria (HIV, tuberculosis, influenza virus, adenovirus or other respiratory infections, active infection by HBV or C). 2. History of multiple allergies, including allergy to Penicillin or other B-lactams. 3. Pregnant and lactating women. 4. Patients with malignant tumors or hemopathies or any state of immunosuppression considered as severe. 5. Patients with autoimmune diseases. 6. Chronic heart failure with ejection fraction less than 30%. 7. Any other condition for which, in the opinion of the main investigator, the subject is considered not to be in compliance with the study.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the safety and efficacy of the administration of two doses of Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in severe or critical pneumonia caused by COVID-19 infection;Secondary Objective: To assess the immunomodulatory effects of MSC against the control group through changes in immune markers, using flow cytometry, collecting samples on days 1, 3, 6, and 15 days after administration of the investigational therapy. To study the expression of coronavirus receptors in mesenchymal cells through the analysis of gene expression of the angiotensin convertase-2 enzyme (ACE-2 or ACE2) and the TMPRSS2 protease used by SARS-CoV-2 as a gateway to the alveolar cell;Primary end point(s): Safety endpoints: Incidence of Adverse Events and Serious Adverse Events, related to the investigational drug or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). Efficacy endpoints: Reduction of the SARS-CoV-2 viral load by PCR on days 6 and 15. Mortality at day 15. Mortality at day 28. Proportion of patients in categories 5, 6 or 7 of the ordinal scale of 7 points on days 15 and 28 days Proportion of patients needing rescue therapy (Tocilizumab, corticosteroids, or therapies under investigation in clinical trials) Time to get an improvement in a category since admission to the ordinal scale.;Timepoint(s) of evaluation of this end point: For safety: 12 months post-infusión For efficacy: At baseline and at 1, 3, 6, 9, 15, 21 and 28 days after infusion, acording to the visits and assessments schedule of the trial protocol.	—

Measure

Time frame

Main Objective: To evaluate the safety and efficacy of the administration of two doses of Allogeneic Adipose Tissue-derived Mesenchymal Stem Cells in severe or critical pneumonia caused by COVID-19 infection;Secondary Objective: To assess the immunomodulatory effects of MSC against the control group through changes in immune markers, using flow cytometry, collecting samples on days 1, 3, 6, and 15 days after administration of the investigational therapy. To study the expression of coronavirus receptors in mesenchymal cells through the analysis of gene expression of the angiotensin convertase-2 enzyme (ACE-2 or ACE2) and the TMPRSS2 protease used by SARS-CoV-2 as a gateway to the alveolar cell;Primary end point(s): Safety endpoints: Incidence of Adverse Events and Serious Adverse Events, related to the investigational drug or the administration procedure, graduated according to the common toxicity criteria scale (CTCAE). Efficacy endpoints: Reduction of the SARS-CoV-2 viral load by PCR on days 6 and 15. Mortality at day 15. Mortality at day 28. Proportion of patients in categories 5, 6 or 7 of the ordinal scale of 7 points on days 15 and 28 days Proportion of patients needing rescue therapy (Tocilizumab, corticosteroids, or therapies under investigation in clinical trials) Time to get an improvement in a category since admission to the ordinal scale.;Timepoint(s) of evaluation of this end point: For safety: 12 months post-infusión For efficacy: At baseline and at 1, 3, 6, 9, 15, 21 and 28 days after infusion, acording to the visits and assessments schedule of the trial protocol.

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Secondary

Measure	Time frame
Secondary end point(s): Prior to MSC treatment, an aliquot will be obtained that will be cryopreserved at UPCIT, to subsequently carry out a study of the possible expression of coronavirus receptors in mesenchymal cells:It will analyze the gene expression of the angiotensin convertase enzyme - 2. (ECA-2 or ACE2) and the TMPRSS2 protease used by SARS-CoV-2 as a gateway to the alveolar cell.;Timepoint(s) of evaluation of this end point: At day 1 and 3, prior to infusion.	—

Measure

Time frame

Secondary end point(s): Prior to MSC treatment, an aliquot will be obtained that will be cryopreserved at UPCIT, to subsequently carry out a study of the possible expression of coronavirus receptors in mesenchymal cells:It will analyze the gene expression of the angiotensin convertase enzyme - 2. (ECA-2 or ACE2) and the TMPRSS2 protease used by SARS-CoV-2 as a gateway to the alveolar cell.;Timepoint(s) of evaluation of this end point: At day 1 and 3, prior to infusion.

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Countries

Spain

Contacts

Public ContactClinical Trial Unit

Red Andaluza de Diseño y Traslación de Terapias Avanzadas-Fundación Progreso y Salud

fabiola.lora@juntadeandalucia.es+34671 533 802NA

Outcome results

None listed

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