Clinical Trial to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Sars-CoV2 Clinical Trial

Official title:

Phase I / II Clinical Trial, Multicenter, Randomized and Controlled, to Assess the Safety and Efficacy of Intravenous Administration of Allogeneic Adult Mesenchymal Stem Cells of Expanded Adipose Tissue in Patients With Severe Pneumonia Due to COVID-19

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04366323
• Other study ID #: AdiQure/COVID-19
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: April 27, 2020
• Est. completion date: December 30, 2021

Study information

• Verified date: April 2022
• Source: Andalusian Network for Design and Translation of Advanced Therapies
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: December 30, 2021
• Est. primary completion date: December 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

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 Blactams.

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.

Related Conditions & MeSH terms

• Pneumonia
• Sars-CoV2

Intervention

Drug:
• ALLOGENEIC AND EXPANDED ADIPOSE TISSUE-DERIVED MESENCHYMAL STEM CELLS
Two doses of 80 million adipose-tissue derived mesenchymal stem cells

Locations

Country	Name	City	State
Spain	Hospital Reina Sofía	Córdoba
Spain	Hospital Universitario Virgen de las Nieves	Granada
Spain	Hospital Universitario de Jerez de la Frontera	Jerez de la Frontera	Cádiz
Spain	Hospital Nuestra Señora de Valme	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Unversitario Virgen del Rocío	Sevilla

Sponsors (1)

Lead Sponsor	Collaborator
Andalusian Network for Design and Translation of Advanced Therapies

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Adverse Event Rate		12 months
Primary	Efficacy of the administration of allogeneic mesenchymal stem cells derived from adipose tissue assessed by Survival Rate		28 days